Lonza Capsules and Health Ingredients

Contracting And Outsourcing Agenda

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09.11.23

MHI Introduces Small-batch Blister Machine

Designed as a reliable, cost-effective solution for development stages, stability testing and initial small-batch production.

02.02.23

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Andelyn Biosciences, Odylia Therapeutics Partner to Manufacture Gene Therapy for Vision Loss

Novel AAV capsid Anc80 enables efficient gene transfer.

02.01.23

Breaking News | Facilities | Industry News

Lonza Breaks Ground on Commercial Drug Product Facility in Stein

Milestone for the development of Lonza’s first large-scale drug product manufacturing facility based in Stein.

02.01.23

Biologics, Proteins, Vaccines | Breaking News | Industry News

New CDMO Vector BioMed Launches Operations

The biomanufacturing company’s mission is to provide access to high-quality lentiviral vectors and address the vector supply bottleneck.

02.01.23

Breaking News | Drug Development | Facilities | Industry News

Mikart Invests in New Liquids and Suspensions Suite

Enhances liquid oral drug product development and manufacturing capabilities of complex formulations.

02.01.23

Breaking News

Jones Healthcare Increases Production Capabilities for Complex Folding Cartons

Installs BOBST NOVACUT 106 ER flatbed die-cutter for complex folding cartons in support of regulated health and wellness clients.

01.31.23

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Lonza Further Invests in Drug Product Manufacturing Capabilities

New filling line to process various modalities, including monoclonal antibodies, bioconjugates, viral vectors, and other gene therapy products.

09.22.21

Breaking News | Clinical Trials

pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray

According to the study, the novel prophylactic nasal spray prevented infection from SARS-CoV-2, the virus that causes COVID-19.

09.22.21

Biologics, Proteins, Vaccines | Breaking News | Clinical Trials

Immunic Inc. Signs In-License Agreement with University Medical Center Goettingen, Germany

Covers the combination of DHODH inhibitors and nucleoside analogues to treat viral infections, including Covid-19.

09.22.21

Breaking News | Clinical Trials

First Patient is Dosed with Triumvira's Investigational TAC-T Cell Adoptive Immunotherapy

TAC01-HER2 was developed for the treatment of HER2-overexpressing cancers.

09.21.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate

Will initiate the GMP manufacturing of the clinical batches of FluGen’s M2SR influenza vaccine candidate for upcoming clinical trials.

09.21.21

Biologics, Proteins, Vaccines | Reader Showcase

Thermo Fisher Launches Gibco AAV Production System

Aims to address the need to make adeno-associated virus (AAV) production more efficient and scalable.

09.20.21

Breaking News | Collaborations & Alliances | Drug Development | Industry News

Oxford Bio Advances Boehringer Oncology Candidate

Receives another milestone payment from Boehringer Ingelheim for progressing a second oncology drug candidate (BI 765049) into the clinic.

09.20.21

Breaking News | Collaborations & Alliances | Industry News

Asychem Partners with LaNova Medicines

Will provide one-stop services such as small molecule drugs, ADC project CMCs, R&D, production and IND China-US declaration.

09.16.21

Tevogen Completes Tech Transfer to CDMO BioCentriq

Reaches commercial manufacturing readiness milestone for its investigational COVID-19 therapy TVGN-489.

09.16.21

BioVaxys Reports Progress on Covid-19 Vax Candidate

Bioproduction partner Wuxi Biologics completes synthesis of recombinant SARS-CoV-2 s-proteins for BVX-0320 and CoviDTH programs.

09.16.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Vaccine Developer Intravacc Adopts Hybrid Business Model

Aims to spur further innovation and sustainable growth over the next five years.

09.16.21

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Clean Cells Expands Bioproduction Capabilities

Invests $15.3 million in new biopharmaceutical production site.

09.16.21

Breaking News | Facilities | Industry News | Inspections

Symbiosis Completes Successful MHRA Audit

Will expand facility at its Stirling, UK site with new storage and warehousing capability.

09.16.21

Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments

Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals

Will make lead compound vonoprazan from Winchester, KY facility if approved by FDA.

09.16.21

Breaking News | Clinical Trials

Syneos Health Acquires Clinical Trial Recruitment and Retention Company StudyKIK

Accelerates product development by better connecting patients, sites and communities.

09.15.21

Breaking News | Clinical Trials | Collaborations & Alliances

Hookipa Enters Clinical Collaboration & Supply Agreement with Merck & Co.

Will evaluate HB-200 in combination with Keytruda (pembrolizumab) in patients with advanced head and neck cancers.

09.15.21

Breaking News | Industry News | Promotions & Moves

Aurion Biotech Makes Strategic Investments in Manufacturing

Appoints Tim Largen as VP of manufacturing to drive cell therapy production strategy and direct collaborations with leading CDMOs.

09.14.21

Drug Development | Laboratory Testing

Eliminating Endotoxins – Reagent Quality Testing for Cell and Gene Therapies

The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.

Garrett Perry, Technical Services Specialists at Teknova 09.14.21

Emergent BioSolutions, Providence Therapeutics Enter Vaccine Manufacturing Partnership

Ink multi-year development and manufacturing agreement for mRNA COVID-19 vaccine candidate, PTX-COVID19-B.

09.14.21

Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

FUJIFILM Diosynth Biotechnologies, NeuExcell Enter Gene Therapy Mfg. Pact

Aims to rapidly advance NXL-001, a potential neuro-regeneration gene therapy to treat ischemic cortical stroke.

09.13.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

AbbVie, REGENXBIO Enter Eye Care Collaboration

Strategic partnership combines eye care and gene therapy expertise.

09.13.21

Breaking News | Formulation Development

AzurRx BioPharma Acquires First Wave Bio Inc.

Expands its GI development pipeline and positions itself for new growth opportunities in the inflammatory bowel disease therapeutic space.

09.13.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

UK Govt. Terminates Valneva COVID Vax Agreement

Valneva is continuing its VLA2001 development plan with Phase III results expected 4Q21 and potential MHRA approval in late 2021.

09.13.21

Breaking News | Promotions & Moves

Boyds Opens US Office in PA

Welcomes Katy Rudnick as VP and head of US regulatory affairs.

09.13.21

Breaking News | Promotions & Moves

Eloxx Pharmaceutical Appoints Ali Hairiri as Chief Medical Officer

Hairiri will oversee clinical development efforts for the company’s pipeline of therapies to treat rare diseases.

09.10.21

Bio News | Breaking News | Collaborations & Alliances | Drug Discovery | Industry News

Boehringer Ingelheim, Twist Bioscience Enter Antibody Discovery Collaboration

Research collaboration covers multiple antibody research programs.

09.10.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Repligen and Navigo Launch Antibody Technology Platform

Introduce industry-first protein A ligand for purification of pH sensitive antibodies.

09.10.21

Antimicrobial Resistance ‘Arms Race’ Realizes Advancements as Post-Antibiotic Era Ensues

Emerging innovations and non-antibiotic approaches to address urgent need to control infectious diseases, including multiple-drug resistant ‘super-bugs’.

Merilee Kern, MBA, Brand Analyst, Strategist and Futurist, and Forbes Business Council Member 09.09.21

Clinical Trials

The Future of Clinical Trials

Dr. Greg Licholai of ICON plc on key market trends, the future of clinical trials and the acquisition of PRA.

Kristin Brooks, Managing Editor 09.09.21

Trust, but Verify

Or, R.I.P, CoA.

Emil W. Ciurczak, DoraMaxx Consulting 09.09.21

Planning For Better Clinical Trials

Faster, smoother and more approvable clinical trials start with you.

Ben Locwin, Contributing Editor 09.09.21

APIs | Drug Development

API Development Trends

Why is it important to consider solid form in API development?

John Mykytiuk, Jamie Marshall and Andrew Blythe-Dickens, Sterling Pharma Solutions 09.09.21

Analytical Services | Laboratory Testing

Raman Spectroscopy for Pharmaceutical Analysis & Quality Control

Raman spectroscopy helps ensure quality along the pharma supply chain of materials—from incoming raw materials through to finished product.

Jacques Ledru, Head of Characterization, Catalent, Nottingham 09.09.21

APIs | Solid Dosage/Creams/Ointments

Spray Drying: A Proven Approach to Enhance the Solubility of APIs

Spray drying is an established particle engineering technology that offers several advantages over other methods used for improving API bioavailability.

Benzion Dolitzky, PhD, VP R&D, Wavelength Pharmaceuticals 09.09.21

APIs | Clinical Trial Materials

Outsourcing the Manufacture of Clinical Trial APIs

What to consider when deciding to partner with a CDMO for manufacturing.

Josh Hoerner, General Manager, Purisys 09.09.21

Drug Delivery

Inhaled Drug Delivery Trends

Designing dry powder devices for inhaled drugs.

Andreas M. Meliniotis, Director of Device Development, Vectura 09.09.21

A Strong Partnership in Drug Development

How CDMOs and consultants mutually benefit their clients.

09.09.21

Clinical Trial Materials | Clinical Trials | Supply Chain

Clinical Trial Kitting

Overcome the challenges to make every sample count.

Claudia Berrón and Arbi Harootoonian, Avantor 09.09.21

Drug Development

Partnering with a CDMO for Orphan Drug Development

Challenges and considerations for advancing rare disease drugs to market.

Susan Billings, Vice President & Global Head of Business Development, Curia (formerly known as AMRI) 09.09.21

Analytical Services | Bioanalytical Services

Putting Laboratory Suppliers to the Test in the COVID Era – and Beyond

Build resiliency into analytical methods through careful consideration of chromatography partners.

Hazel Dickson, PhD, Marketing Manager, Chemistry Group, Waters Corporation 09.09.21

Choosing and Managing a CDMO

Speed up your time-to-market, keep development costs under control and smooth the FDA approval and commercial launch process.

Dana Toops, President, Avema Pharma Solutions 09.09.21

Global Outsourcing Trends

Lonza’s Jan Vertommen talks about building global manufacturing and development networks to advance innovative, life-saving therapies.

Tim Wright, Editor, Contract Pharma 09.09.21

Breaking News | Chemistry | Industry News | Laboratory Testing

Sterling Pharma Solutions Creates Flow Chemistry CoE

Completes initial phase of investment at its site in Dudley, UK for research into commercial applications of continuous flow chemistry.

09.09.21

Breaking News | Industry News

Sanofi to Acquire Kadmon in $1.9B Deal

Adds Rezurock, a recently FDA-approved first-in-class treatment for chronic graft-versus-host disease (cGVHD)

09.08.21

Breaking News | Industry News

Citius Acquires Cancer Drug Asset from Dr. Reddy's

Expands late-stage pipeline with the acquisition of exclusive license rights to E7777, an improved formulation of previously FDA-approved ONTAK.

09.08.21

Breaking News | Industry News | Information Technology

Medrio and Phastar Partner to Leverage Metadata for Advanced Data Visualization

Aim to monitor compliance, patient burden and any anomalies that may ultimately impact the interpretation of results.

09.08.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

Recro and BioCorRx Expand Development and Manufacturing Relationship

Will support BICX104, an implantable naltrexone pellet for the treatment of opioid use disorder.

09.08.21

cGMP Manufacture | Drug Development | QA/QC

Three Tips for Navigating Post-Approval Pharmacovigilance

Seamlessly transition from regulatory reporting to post-approval safety surveillance in today’s market.

Emmanuel Belabe, Associate Vice President, Safety Product Management, ArisGlobal, Nina Patel Lahanis, Associate Vice President, Safety Science, EVERSANA 09.08.21

Breaking News | Clinical Trials | Collaborations & Alliances

LTO Network, Sphereon, Triall to Deliver COVID-19 Trials Anchored to Blockchain Tech

Will anchor research data to the blockchain, securing the integrity and security of clinical trial data.

09.07.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

CEVEC, UCB Ink AAV Mfg. Technology Agreement

UCB will use of CEVEC’s ELEVECTA AAV manufacturing technology in gene therapy.

09.07.21

Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery

Adaptimmune, Genentech Enter Strategic R&D Collaboration

To research, develop, and commercialize cancer-targeted Allogeneic T-cell therapies.

09.07.21

Bio News | Breaking News | Collaborations & Alliances | Facilities | Industry News

CRB, Umoja Biopharma Begin Construction at Development and Manufacturing Site

CRB is using its ONESolution Integrated Project Delivery method to design and construct Umoja’s development and manufacturing facility.

09.03.21

Clinical Trials | Information Technology

Clinical Trials are Transforming Right Before Our Eyes

Decentralized clinical trials, an innovation just a short time ago, are now mainstream.

Kristin Brooks, Managing Editor, Contract Pharma 09.03.21

Breaking News | Cytotoxics and High Potency Manufacturing | Industry News

Ardena Acquires Idifarma from Suanfarma and Sodena

Adds spray drying technology and high potency capabilities.

09.02.21

Promotions & Moves

Avacta Names Fiona McLaughlin as Therapeutics Division CSO

Dr. McLaughlin is a highly experienced oncology drug developer, bringing over 25 years of experience in research and translational drug development.

09.02.21

Breaking News | Collaborations & Alliances

Thermo Fisher, AstraZeneca Collaborate on NGS-Based Companion Diagnostics

Aim to accelerate development and introduction of targeted precision medicine therapies for patients.

09.02.21

Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery

Secarna, Evotec Expand Strategic Antisense Discovery Pact

To discover, research and develop programs leveraging Secarna’s antisense oligonucleotide expertise with Evotec’s discovery and development capabilities.

09.02.21

Bachem reports excellent results for the first half-year 2021

Sales of CHF 500 million are now expected for the year 2021.

Breaking News | Injectables | Reader Showcase | Solid Dosage/Semi-solids

MHI EAGLE-Omni Blister Machine Features Enhanced Printer Module

Designed for packaging development, materials testing and production, the unit performs forming, sealing and punching operations at sequential stations.

09.01.21

FairJourney Biologics Expands into New Facilities

Newly purpose-built research center in Porto, Portugal supports rapid expansion.

09.01.21

Breaking News | Industry News

Cytocom to Become Statera BioPharma

New name reflects strategic focus on addressing autoimmune and inflammatory diseases, blood disorders, infectious disease and cancer.

08.31.21

Biologics, Proteins, Vaccines | Breaking News

Avantor Commences Multi-Year Investment in Global Hydration Capabilities

Completes a major expansion of its facility in Gliwice, Poland, and begins a multi-stage expansion of its facility in Aurora, Ohio.

08.31.21

Breaking News | cGMP Manufacture | Clinical Trial Materials | Formulation Development | Promotions & Moves

Avomeen Appoints Formulation and Clinical Trial Mfg. Director

Alex Garner will work to further expand and strengthen Avomeen’s formulation and clinical trial manufacturing capabilities to support biopharmaceutical clients.

08.31.21

Breaking News | Industry News | Promotions & Moves

Forge Biologics Expands Leadership Team

Announces two key hires in process development and medical affairs.

08.30.21

Breaking News | Facilities | Industry News

USAntibiotics Reopens Manufacturing Facility

At full capacity, the Bristol, TN facility will be able to meet 100 percent of the nation's demand for Amoxicillin.

08.30.21

Bio News | Breaking News | Facilities | Industry News

Umoja Biopharma Breaks Ground on Cancer Drug Manufacturing Facility

State-of-the-art 146,000 square foot facility in Louisville, CO will produce next-generation CAR T immunotherapies.

08.30.21

Breaking News | Industry News | Promotions & Moves

PharmaBlock Appoints Dr. Xudong Wei as SVP and Head of CDMO Business

Wei’s scientific and management career spans over 20 years.

08.30.21

Breaking News | Promotions & Moves

Lonza Appoints Philippe Deecke as CFO

Deecke joins Lonza Group from Novartis, where he held a succession of senior finance positions.

08.27.21

Breaking News | Drug Development | Industry News

Innovent Biologics, Bolt Biotherapeutics Enter Immuno-oncology Alliance

Will leverage Innovent's therapeutic antibody portfolio and discovery capability against undisclosed oncology targets in combination with Bolt's ISAC technology

08.27.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Drug Discovery | Industry News

Heat Biologics Launches New Drug Discovery Subsidiary

Will focus on the development of a drug discovers paradigm to enable rapid drug development.

08.26.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

iBio Enters AI Partnership with RubrYc Therapeutics

Secures option to license additional antibodies developed with RubrYc’s predictive algorithms.

08.26.21

Breaking News | Collaborations & Alliances | Drug Development | Industry News

SignalRx, Crystec and ADYA Partner to Develop Treatment for SARS-CoV-2 Related Illnesses

Aim to develop an inhaled dry powder formulation of SF2523.

08.26.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Pfizer, BioNTech Collaborate with Brazil’s Eurofarma to Manufacture Covid-19 Vaccines

The annual production is expected to exceed 100 million finished doses annually for Latin America.

08.26.21

EOC Pharma and Chime Biologics Extend Partnership

For the CMC development of EOC202, a recombinant LAG-3 protein for cancer immunotherapy.

08.26.21

Breaking News | Collaborations & Alliances

Cryoport and Mitsubishi Logistics Corporation Partner

Will work together to bring temperature-controlled supply chain solutions to Asia-Pacific.

08.25.21

Breaking News | cGMP Manufacture | Drug Development | Industry News

ExoCoBio to Build World’s First Clinical Grade Exosome GMP Mfg. Facility

Will invest approximately $20 million to install two types of advanced exosome production lines in Osong South Korea.

08.25.21

Breaking News | Collaborations & Alliances

Lilly, Lycia Therapeutics Enter Multi-Year R&D Alliance

Will leverage Lycia's LYTAC protein degradation technology to discover, develop and commercialize targeted therapeutics in immunology and pain.

08.25.21

APIs

Propofol – A Bachem Success Story

The COVID-19 pandemic has rapidly expanded awareness of the API Propofol, produced by Bachem in Vionnaz.

FDA Approves Pfizer-BioNTech COVID-19 Vaccine COMIRNATY

Grants first full approval for COVID vaccine.

08.23.21

Bio News | Breaking News | Industry News

Pfizer to Acquire Trillium Therapeutics for $2.3B

Strengthens oncology portfolio with addition of next-generation, investigational immuno-therapeutics for hematological malignancies.

08.23.21

Bioanalytical Services

Ensuring Equitable Access to Next-generation Sequencing in Oncology

Recent advances in sequencing techniques have transformed cancer treatment.

Gang Song, Ph.D., CEO & Co-Founder, Pillar Biosciences 08.20.21

Bio News | Breaking News | Industry News

PBS Biotech Scales-Up Manufacturing Solutions for Cell Therapies

Raises $10 million to grow its product offerings and capabilities.

08.20.21

cGMP Manufacture | Fill/Finish | Parenterals

Modularity in Injectables Manufacturing

Raffaele Pace of Stevanato Group discusses injectable trends, challenges for manufacturers, and solutions for production customization.

Kristin Brooks, Managing Editor, Contract Pharma 08.19.21

Breaking News | Facilities | Industry News

Sai Life Sciences Opens New Biology Facility in Hyperbad, India

Positions itself as a differentiated player in Discovery Biology.

08.19.21

Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments

Alladapt Initiates Buildout of New Manufacturing Facility

For production of novel, investigational oral immunotherapeutic designed to treat food allergies.

08.19.21

Bio News | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News

Beroni Begins Manufacture of Anti-Cancer Drug PENAO

Inks contract manufacturing deal with Aurigene Pharma Services.

08.19.21

Drug Development | Drug Discovery

Antimicrobial Resistance ‘Arms Race’ Realizes Advancements as Post-Antibiotic Era Ensues

Emerging innovations and non-antibiotic approaches to address urgent need to control infectious diseases, including multiple-drug resistant ‘super-bugs’

Merilee Kern 08.18.21

Breaking News

AltheaDx Expands Commercial Leadership Team

Appoints Jonathan Yount as SVP, Sales and Croom Lawrence as SVP, Marketing.

08.18.21

Clinical Trials | Information Technology

Enabling Decentralized Clinical Trials through Digital Transformation

Adopting a strategy of “bringing the technology to the data.”

Temitope Keyes, Executive Director, Business Development at Cmed Technology 08.17.21

Innoforce Expands Cell and Gene Therapy Capabilities

Opens analytical development and process development facility in Hangzhou, China.

08.17.21

Bio News | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News

Cellectar, Evergreen Enter Clinical Manufacturing and Supply Agreement

Evergreen to provide clinical and commercial supply of iopofosine I-131.

08.17.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Biotage Opens New UK Facility

Triples production capacity for equipment crucial in the supply chain for the production of mRNA vaccines.

08.17.21

Breaking News | Drug Delivery | Industry News

Aptar Pharma, Pharmaxis Enter Orbital DPI Agreement

Aptar has the option to acquire rights to Pharmaxis’ Orbital high payload dry powder inhaler.

08.17.21

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Syngene Expands Biopharma Manufacturing Capacity

Sets up a state-of-the-art microbial facility; expands mammalian facility.

08.17.21

Breaking News | Industry News | Promotions & Moves

Sharp Names Paul Thomas as Business Development Manager for UK Commercial Services

Thomas has over twenty years’ experience in healthcare and pharma packaging sales.

08.13.21

Breaking News | Industry News

Recro Acquires IRISYS to Expand CDMO Capabilities

From pre-IND development to commercial manufacturing and packaging for wide range of dosage forms.

08.13.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

Lykan and Vineti Form Cell Therapy Agreement

Partnership will streamline process development and manufacturing to deliver therapies to patients in need.

08.13.21

Breaking News | Facilities | Industry News | Packaging & Tracking

Comar Cuts Ribbon on New West Coast Facility

The 230,000 square foot facility houses injection molding, injection blow molding and injection stretch blow molding cells.

08.13.21

Breaking News | Collaborations & Alliances | Industry News

TerraPower, Cardinal Health Enter Manufacturing Agreement

Collaboration will increase access to Actinium-225, a medical isotope used with radiopharmaceutical drugs in clinical trials for advanced cancer therapy.

08.13.21

Breaking News | Industry News

FDA Amends EUAs for COVID-19 Vaccines

Allows for the use of an additional dose of the Pfizer-BioNTech and Moderna COVID-19 vaccines in certain immunocompromised individuals.

08.13.21

Breaking News | Promotions & Moves

Catalent Appoints GM of Philadelphia Clinical Supply Facility

Harold A. Jenkins III brings more than 28 years of leadership experience.

08.13.21

Clinical Trials | Cold Chain Management | Logistics

Flexible Ultracold Chain Critical to Decentralized Clinical Trials

Addressing barriers to further grow and accelerate the adoption of patient-focused DCTs.

Timothy Root, Marketing Director, Stirling Ultracold 08.12.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News | Scale-up/Technology Transfer

Lonza, Sheba Medical Center Leverage Cocoon Platform for Cell Therapy

Customizable, patient-scale cell therapy platform aims to streamline manufacturing to improve process efficiency and reliability.

08.12.21

Breaking News | Drug Development

Precision NanoSystems Announces Plans to Expand Global Headquarters

Will improve capabilities to include the clinical manufacturing of RNA vaccines and therapeutics.

08.11.21

Biologics, Proteins, Vaccines | Breaking News

Evotec Opens cGMP Manufacturing Facility in Redmond, WA

Expands capabilities into commercial biologics manufacturing and adds late stage clinical development and commercial supply for drug substance.

08.11.21

Clinical Trials | Logistics

Fortifying Logistics with Technology for Decentralized Trials

UPS Healthcare President Wes Wheeler shares insights on key challenges associated with decentralized clinical trials and how they can be overcome.

Kristin Brooks, Managing Editor, Contract Pharma 08.11.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Lumen Bioscience, Google Partner to Apply ML to Biologics Manufacturing

Aims to double biomanufacturing productivity.

08.11.21

CMO Becoming a Powerhouse With Expansions and New Facilities, Looking to Add Strategic Customers

Aphena is a service provider in the pharmaceutical, OTC, medical device, biologics and personal care industries.

Breaking News | Drug Development | R&D

Veraxa Biotech and Indivumed to Jointly Develop Precision Oncology Antibody Drugs

Aim to discover new possibilities for cancer treatment in the shortest-possible time.

08.10.21

APIs | Formulation Development

Microspheres and Nanoparticles for Peptide Delivery

Navigating The Benefits And Challenges Of Microspheres And Nanoparticles For Peptide Delivery.

Breaking News | cGMP Manufacture | Drug Development | Promotions & Moves

Metrics Appoints Senior Director, Scientific and Technical Affairs

Anshul Gupte will be responsible for technical and scientific oversight of client projects, reporting to John Ross, President of Metrics Contract Services.

08.10.21

Breaking News | Industry News

KYOWA, Bora Pharmaceuticals Enter Mfg. Pact

Upon approval in Japan, Bora will be the commercial manufacturing site for the generic product production.

08.10.21

Breaking News | Financial Reports

BioNTech’s 2Q Revenue Soars

Growth due to rapid increases in the supply of BNT162b2 as BioNTech and Pfizer evaluate a third dose to boost efficacy against Delta variant.

08.09.21

Biologics, Proteins, Vaccines | cGMP Manufacture

A Look Into COVID Vaccines, Development and Outsourcing

Fiona Barry of PharmSource discusses COVID vaccines in development and CMO outsourcing trends.

08.09.21

cGMP Manufacture | Drug Development | Promotions & Moves

Syngene Adds Senior Leadership in the U.S.

Alex Del Priore appointed Senior Vice President, Manufacturing Services, and Alan Collis appointed Vice President, Integrated Drug Discovery Services.

08.06.21

Breaking News | cGMP Manufacture | Fill/Finish | Industry News

GRAM Expands Footprint with New Finishing Center

New 110,000 sq.-ft. finishing center is the injectable CDMO's fourth GMP manufacturing facility.

08.06.21

Breaking News | Facilities | Industry News

Metrics Contract Services Expands Facility in Greenville, NC

Adds 3,760 square feet of production space and new equipment.

08.05.21

Clinical Trials | Information Technology

Leveraging Clinical Trial Outcomes Through Medication Adherence

Addressing adherence and trial failure, the problem with traditional methods, and the smart way to monitor adherence.

Bernard Vrijens, CEO & Scientific Lead, AARDEX Group 08.05.21

Breaking News | Collaborations & Alliances | Industry News

Purdue University & US Pharmacopeia Launch Pharmaceutical Industry Technology Forum

The webinar series will focus on the benefits of 3D-Printing pharmaceutical medications.

08.05.21

The Real Cost of Bringing Manufacturing Home

Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.

08.04.21

cGMP Manufacture | Formulation Development | Scale-up/Technology Transfer

Solving Solubility Challenges for a Novel Oncology Drug

Learn how Lubrizol Life Science Health solved bioavailability challenges and scaled a commercially viable formulation of a new cancer treatment.

Breaking News | Collaborations & Alliances | Drug Development | Industry News | Preclinical Outsourcing

Nanoform, Boehringer Ingelheim Sign Master Services Agreement

Will address bioavailability and solubility challenges in the pre-clinical early development stages.

08.03.21

Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments

DisperSol, Catalent Enter Manufacturing Collaboration

To establish KinetiSol technology manufacturing hub for DisperSol’s pipeline.

08.03.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Global Cell & Gene Therapy Mfg. Market Could Reach $57.4B by 2028

Market estimated to grow at CAGR of 20% from 2021 to 2028 due to an exponential rise in clinical pipeline along with rising number of regulatory approvals.

07.30.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

CellCAN and CCRM Partner to Launch CATTI

New Institute will tackle gaps in training Canada’s GMP workforce.

07.29.21

Breaking News | Facilities | Industry News

Nexus Pharmaceuticals Opens State-of-the-Art Manufacturing Facility

Phase I investment of $100 million supports a new three-story manufacturing facility.

07.29.21

Abzena, BioXpress Therapeutics Enter Biosimilar Tie-up

Partnership to support the development and manufacture of biosimilars for global customers.

07.29.21

Breaking News | Industry News

Amgen to Acquire Teneobio for $900M

Includes Teneobio's bispecific and multispecific antibody technologies, heavy-chain only platform and T-cell engager platform.

07.28.21

Breaking News | Clinical Trials | Drug Development | Industry News | Information Technology

Almac, THREAD to Integrate Technologies for Clinical Trials

Integrating technology platforms aims to provide sponsors and CROs with a full range of tools designed to reduce the risk of trial delays.

07.28.21

Breaking News | Drug Development | Industry News

Lantern Pharma Reacquires Irofulven from Allarity Therapeutics

Based on early Phase II results, Lantern to advance development in bladder and prostate cancer with a key mutation in the ERCC2/3 genes.

07.28.21

Promotions & Moves

ImmunoGenesis Opens Research Lab, Adds Key Roles

To support the expansion of the company's recently licensed key development assets, clinical and business development activities.

07.28.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

ValenzaBio, ProBioGen Enter Cell Line Pact

Aims to maximize cell line productivity leveraging ProBioGen's GlymaxX technology for ValenzaBio's clinical-stage antibody.

07.28.21

Breaking News | Industry News | Laboratory Testing

Cerba Research Wins NIH Contract for Central Lab Services

To provide clinical lab screening and safety testing for NIAID-supported clinical trials in the area of infectious disease.

07.28.21

Breaking News | Facilities | Industry News

Archimica Completes Expansion of Its Multi-Purpose Manufacturing Capacity

Recent investment adds significantly to the company's capabilities.

07.27.21

Biologics, Proteins, Vaccines | Drug Development

AAV-Mediated Gene Therapy: Quantifying Viral Titer and Integrity

Droplet Digital PCR offers precise potency data, critical for the proper dosing of gene therapies.

Mark White and Marwan Alsarraj , Digital Biology Group at Bio-Rad 07.27.21

Breaking News | Collaborations & Alliances | Facilities | Industry News

Grifols Expands Activity in Africa

Will set up an intravenous solutions manufacturing plant in Nigeria.

07.27.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

AavantiBio, Aldevron Form Gene Therapy Partnership

Aldevron will supply plasmids to AavantiBio’s planned vector core and CDMO partners.

07.27.21

Breaking News | cGMP Manufacture | Industry News

WuXi Biologics Receives Manufacturing License from German Health Authorities

The inspections comprised areas of cGMP manufacturing required for receiving the permit, as well as commercial production approval.

07.26.21

Breaking News | Clinical Trials | Industry News | Information Technology

WCG Acquires eClinical Provider VeraSci

Aims to address growing demand for scientific and technology solutions for remote data capture, hybrid virtual studies and decentralized clinical trials.

07.26.21

Fill/Finish | Reader Showcase

TurboFil Introduces Benchtop Syringe Filler

Designed to offer full control of filling parameters in single or dual operation and provide accurate, consistent fills at a rate of up to 12 pieces per minute.

07.23.21

Breaking News | Facilities

Capsida Biotherapeutics Opens Facility in Thousand Oaks

New 15,000 square-foot facility will enable industry leading end-to-end gene therapy manufacturing capability.

07.23.21

Bio News | Breaking News | Industry News

Catalent Biologics Launches GPEx Lightning Cell Line Expression Technology

Designed to shorten drug substance development timelines by up to three months.

07.22.21

Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News

Marvel Biotechnology Begins cGMP Manufacturing of Lead Candidate

Enters manufacturing agreement with Ausun Pharma for lead asset MB-204.

07.22.21

Breaking News | CRO News | Industry News

Calyx Expands US Presence in Response to Growing Demand

RTP-based US headquarters established to meet pharmaceutical companies’ and CROs’ increasing needs for e-clinical and regulatory solutions.

07.22.21

Trials & Filings

Japan First to Approve Roche’s Ronapreve to Treat COVID-19

Full approval is based on a global phase III trial which found casirivimab and imdevimab reduced hospitalization or death by 70%.

07.21.21

Breaking News | Promotions & Moves

TCR2 Therapeutics Appoints Chief Technical Officer

Peter Olagunju to oversee process development, manufacturing, quality control and technical operations for the company’s TRuC-T cell programs.

07.21.21

Biologics, Proteins, Vaccines | Drug Development | Reader Showcase

Thermo Fisher Scientific Launches Heracell Vios CR CO2 Incubator

First-in-market CO2 incubator combines optimal cell growth capabilities with certified cleanroom compatibility.

07.21.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Pfizer, BioNTech Partner with Biovac for COVID-19 Vax in Africa

Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network.

07.21.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Catalent Plans $100M Expansion of Biologics Mfg. Capabilities in Italy

Initial phase includes installation of two 2,000-liter single-use bioreactors and associated investments to support early-and late-phase clinical development.

07.21.21

Vetter’s New Clinical Mfg. Site Now Fully Integrated

Expands clinical capacity to address growing market demand.

07.21.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings

Eisai, Biogen’s Lecanemab Gets Breakthrough Designation in AD

Based on pre-specified analysis showing consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.

07.20.21

Breaking News | Collaborations & Alliances | Industry News | Parenterals

ExeVir, Mithra CDMO Enter Manufacturing Collaboration

Manufacturing of ExeVir's candidate product for Covid-19 Treatments will take place at Mithra CDMO's new injectable facility.

07.20.21

Breaking News | Facilities | Industry News

Evergreen Expands Alpha Radiopharmaceutical Production Capabilities

A GMP state-of-the-art alpha emitter production center will be integrated into Evergreen’s existing facility.

07.20.21

Breaking News | cGMP Manufacture | Clinical Trial Materials | Facilities | Industry News

ImmVira Launches Pilot-scale Production Line

To expedite the advancement of next-generation oncolytic virus clinical trials.

07.20.21

Samsung Biologics, Kineta Enter Development and Manufacturing Agreement

Samsung's San Francisco R&D center and South Korea headquarters to offer end-to-end CDMO service for anti-VISTA antibody immunotherapy.

07.20.21

Biologics, Proteins, Vaccines | Breaking News | Industry News | Preclinical Outsourcing

Lonza, CN Bio Partner on Prevalidated Hepatocytes for Organ-on-a-chip Range

Lonza will supply cells to be prequalified for use in CN Bio’s innovative PhysioMimix OOC range of Single- and Multi-Organ Microphysiological Systems.

07.19.21

Clinical Trial Supply Services

The constant drive for efficiency has become an essential element of any business process, across all industries.

07.19.21

Reader Showcase | Serialization

Covectra Enhances ATLAS Serialization Platform for Repackaging

Designed to simplify the repackaging of pre-serialized pharmaceutical products.

07.19.21

Clinical Trials | CRO News | Information Technology | Reader Showcase

Quanticate Launches Updated Remote Source Data Verification Platform

Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location

07.19.21

Breaking News | Clinical Trials | Industry News | Information Technology

Calyx Opens U.S. HQ Near Research Triangle Park

RTP-based headquarters established to meet growing needs for eClinical and regulatory services.

07.19.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News

BioNTech to Acquire Kite’s TCR Cell Therapy Platform and Mfg. Facility

Strengthens cell therapy pipeline with individualized solid tumor Neoantigen TCR cell therapy R&D program and adds manufacturing footprint in North America.

07.19.21

Breaking News | cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News

Lonza Extends Large-Scale MAb Commercial Supply Pact

To provide commercial-scale manufacture of monoclonal antibodies under a long-term agreement at Visp site.

07.19.21

Astellas

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07.16.21

Biogen

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07.16.21

Teva

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07.16.21

Curtana and Catalent Enter Brain Cancer Drug Partnership

Sign development and manufacturing agreement for brain cancer drug CT-179.

07.16.21

Bio News | Breaking News | Industry News | Promotions & Moves

Vibalogics Advances Growth with Leadership Hires

Pharma industry vet Roger Lias joins the CDMO as chief commercial officer.

07.16.21

Breaking News | CRO News | Facilities | Industry News

CRO Charnwood Molecular Expands Capabilities

$75m construction project in Loughborough creates flexible facility for the growing CRO.

07.16.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Industry News

GentiBio, Forge Biologics Ink Development and Manufacturing Agreement

Partnership to support GentiBio’s cell therapy pipeline with AAV process development, scale up and GMP manufacturing services.

07.16.21

Clinical Trials | Information Technology | Reader Showcase

Almac Offers Expedited IRT Solutions for COVID-19 Trials

Launches the expedited deployment and support of multiple Interactive Response Technology (IRT) solutions in support of COVID-19 treatments

07.16.21

Analytical Services | Supply Chain

Drug Product Safety and Security

Is it even possible in an elongated supply chain?

Emil Ciurczak, President, Doramaxx Consulting 07.16.21

Breaking News

Thermo Fisher Scientific Opens New Plasmid DNA Manufacturing Facility

Enables the company to meet the rapidly growing demand for plasmid DNA-based therapies and vital mRNA-based vaccines.

07.15.21

Breaking News | Clinical Trials | Industry News | Information Technology | Logistics

UPS Healthcare, THREAD Partner on Decentralized Clinical Trial Platform

Brings together THREAD's digital platform and Marken's clinical trial logistics services to create a single seamless workflow for clients and patients.

07.15.21

Breaking News | Clinical Trials | Industry News | Information Technology

Medable Opens EMEA HQ in Dublin

Expands European presence to grow market for decentralized clinical trials.

07.15.21

Breaking News | Industry News | Promotions & Moves

Daicel Chiral Technologies Opens New Facility in Ann Arbor, MI

Also hires new HPLC chemist and promotes sales representative.

07.14.21

Batavia Manufactures IAVI’s Lassa Fever Vax Candidate

Uses innovative 'scale-X' bioreactor to support Phase I clinical trials.

07.14.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Ashfield Launches Cell & Gene Therapy Commercialization Network

EmerGENE is designed to support small and midsize biotechs with the commercialization of their discoveries.

07.14.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Curia to Acquire US-based LakePharma

Expanding end-to-end R&D capabilities and scale for biologics.

07.14.21

Breaking News | Cytotoxics and High Potency Manufacturing | Industry News | Solid Dosage/Creams/Ointments

Idifarma Launches Accelerated Pathway for Complex Drugs

‘Simply to Clinic’ leverages expertise in oral standard and highly potent drugs to take projects from pre-formulation to clinical trials.

07.14.21

Breaking News | Drug Development | Industry News

Novo Nordisk Acquires Prothena’s ATTR Program in $1.2B Deal

To develop the Phase 2 ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy.

07.13.21

Leading Teams in a Changing Clinical Research Environment

...

07.13.21

Building Relationships with Clinical Research Sites

...

07.13.21

Breaking News | Formulation Development | Industry News

Catalent, JOS Pharmaceuticals Enter Zydis Formulation Agreement

Catalent to undertake a feasibility study for the potential development of a CBD product for use as an anesthetic leveraging its ODT technology.

07.13.21

Curia to Acquire Integrity Bio

Expands biologic formulation and fill-finish capabilities.

07.13.21

Breaking News | cGMP Manufacture | Drug Development | Formulation Development | Industry News

Recro Pharma Inks Development and Mfg. Pact

To support a client’s ongoing clinical development of an orally administered, minimally-absorbed investigational compound.

07.13.21

Aseptic Processing | Breaking News | Facilities | Fill/Finish | Industry News

SP Doubles Manufacturing Capacity for Fill-Finish and Freeze Dryers

New plant opened for SP i-Dositecno aseptic filling lines equipment and global workforce increased to grow capacity and capabilities.

07.12.21

Breaking News | Industry News

Cigarette Maker Philip Morris to Buy Vectura for $1.2B

Acquisition is part of the cigarette maker’s ‘Beyond Nicotine’ strategy and expands its product pipeline development capabilities in inhaled therapeutics.

07.12.21

Laboratory Testing

Overcoming the Customization Conundrum

A case study on automating diagnostic reagent filling.

Deborah Smook, VP of Marketing & Business Development, TurboFil Packaging Machines LLC 07.12.21

I-Mab Expands Next-Gen Novel Oncology Portfolio

Expands pipeline of antibody assets leveraging cutting-edge mRNA and AI technology platforms.

07.09.21

Batavia to Develop Clinical Process for RocketVax’s COVID-19 Vaccine

After successful completion, Batavia will continue to scale-up and optimize the process for commercial scale.

07.08.21

Analytical Services | Breaking News | Industry News | Laboratory Testing

LGM Pharma Launches Analytical Services for Drug Developers and Manufacturers

Analytical testing and stability services covers both drug substance and drug product.

07.08.21

Biologics, Proteins, Vaccines | cGMP Manufacture

Can mRNA Facilities Really be Flexible?

Four key questions to accommodate growth and expansion.

Jeff Heil, PE , Novel Therapy SME, DPS Group Global 07.08.21

Breaking News | Promotions & Moves

Thermo Fisher Names New Chief Medical Officer

Alan Sachs will assume the newly established role.

07.07.21

Breaking News | cGMP Manufacture

Thermo Fisher Scientific Expands Gene Therapy Portfolio

Adds new set of solutions to support more efficient adeno-associated viral manufacturing.

07.07.21

VectorBuilder, Univercells Form Viral Vector Production Pact

Aims to develop a portfolio of optimized viral vector manufacturing protocols.

07.06.21

Facilities | Laboratory Testing | Logistics

A Guide to Outsourced Stability Storage

Watch the on-demand webinar presented by Maureen Gilbert, Site General Manager at Source BioScience.

BioMed X Expands Collaboration with Merck

Launches a new joint research program in oncology.

07.06.21

Breaking News | Facilities | Industry News | Validation

Almac’s Charnwood Site Receives ISO Certifications

Achieves globally recognized Health & Safety and Environmental Management System certifications.

07.06.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Cytotoxics and High Potency Manufacturing | Industry News

Novasep, Exelixis Ink ADC Manufacturing Agreement

Covers the cGMP clinical manufacturing of a next-generation ADC drug candidate.

07.06.21

Breaking News | Promotions & Moves

Avid Bioservices Appoints Esther M. Alegria to Board

Former SVP of global manufacturing at Biogen bring nearly 30 years of biopharmaceutical industry experience.

07.02.21

Breaking News

Lonza Finalizes Divestment of Specialty Ingredients Business

The agreement with Bain Capital and Cinven was previously announced in February.

07.02.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

Aragen Expands Discovery Research Agreement with Boehringer Ingelheim

Aims to accelerate the discovery pipeline of Boehringer Ingelheim.

07.01.21

Breaking News | Collaborations & Alliances | Industry News

Innovent Biologics Signs License Agreement with Synaffix

Synaffix will provide proprietary ADC technologies to enable Innovent to rapidly progress one of its antibodies as a best-in-class ADC candidate.

07.01.21

APIs | Breaking News | Facilities | Industry News

Almac Expands Crystallization Capabilities

A new Empyrean X-ray powder diffractometer is part of the investment.

07.01.21

Breaking News | CRO News | Drug Development | Drug Discovery | Industry News

Frontage to Acquire Quintara Discovery

Quintara provides in vitro ADME profiling, bioanalytical services, and dedicated assay development and compound screening.

07.01.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Rentschler Expands Complex Antibodies Production in Germany

Expands capacity with 2,000-liter bioreactor to address increasing demand for complex antibodies.

06.30.21

Breaking News | Drug Development

CureVac Appoints Dr. Malte Greune as COO

Dr. Florian von der Mülbe will shift focus exclusively toward the expansion and accelerated development of The RNA Printer.

06.30.21

Analytical Services | Breaking News | cGMP Manufacture | Collaborations & Alliances | Formulation Development

Selexis, KBI Biopharma, Immatics Partner to Advance TCR Program

Will leverage integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, designed to detect, target and attack tumor cells.

06.30.21

eTheRNA, Quantoom Collaborate to Develop Novel RNA Production System

Aims to develop an RNA production system for both research and GMP-grade material.

06.29.21

Breaking News | Clinical Trials | Collaborations & Alliances | Industry News | Information Technology

CMIC and Lokavant Partner to Deploy Clinical Trial Intelligence Platform

Enter first phase of multi-year partnership to deploy predictive analytics platform for monitoring and management of clinical trials in Asia-Pacific.

06.29.21

Breaking News | Collaborations & Alliances | Facilities | Industry News

WuXi STA Chooses Middletown Delaware for New Pharma Manufacturing Campus

The CDMO is bringing about 500 jobs to Middletown, with site expected to open in 2024.

06.29.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings

AskBio’s Gene Therapy Program Gets Fast Track Designation

LION-101 is a recombinant adeno-associated virus based vector being developed as a one-time intravenous infusion for Limb-Girdle Muscular Dystrophy Type 2I/R9.

06.28.21

APIs | Breaking News | cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News

Lonza Expands API Development, Mfg. Facility in China

20M CHF investment will include three 1,000L GMP trains and new development and GMP labs with HPAPI capabilities.

06.28.21

APIs | Drug Development | Formulation Development

QBD Addresses API Supply in Orphan Drug Formulation

Due to the high costs and low demands of the drug product, it is important to efficiently use API supply during the formulation process.

Formulation Development

Tryp Therapeutics Partners with Alcami for Proprietary Formulations

The agreement represents another step toward the proprietary manufacturing, formulation, and delivery of products for Tryp’s PFNTM program.

Clinical Trials | Information Technology

The Power and Promise of Decentralized Trials

Clinical researchers turned to a range of digital solutions to address the effects of the COVID-19 pandemic on trials.

Derk Arts, CEO, Castor 06.25.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Genezen Breaks Ground on cGMP Lentiviral Vector Production Facility

First phase will see the construction of a 25,000 square feet site including a process development lab expansion.

06.25.21

APIs | Breaking News | Facilities | Industry News

Novasep Upgrades API Manufacturing Facility

A $7.3 million investment will be made over 3 years to modernize the Mourenx site.

06.25.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News | Process Development

Catalent to Acquire RheinCell Therapeutics

Strengthens path towards industrialization of induced pluripotent stem cell-based therapies.

06.25.21

Breaking News | Industry News | Solid Dosage/Creams/Ointments

Metrics Strengthens Oral Solid Dose Capabilities

Increases capacity with new equipment investment.

06.25.21

Breaking News | Collaborations & Alliances

CellPoint and Lonza Enter CAR-T Cell Collaboration

Will work together to deliver CAR-T Cell therapies to patients at point-of-care.

06.24.21

Breaking News | Clinical Trial Materials

Chemomab and AGC Biologics Partner to Manufacture CM-101 for Phase II/III

AGC Biologics will manufacture the clinical trial materials at its site in Copenhagen to support clinical testing and launch readiness.

06.24.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Senti Bio Invests in Cell Therapy Manufacturing Facility

92,000 square-foot cGMP facility will be designed to support clinical and commercial-scale production of allogeneic CAR-NK cell pipeline.

06.23.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Frontera Therapeutics Starts GMP Manufacturing Facility Construction

Designed for clinical manufacturing and initial commercial manufacturing of rAAV gene therapy products.

06.23.21

AbCellera to Build Antibody Manufacturing Facility in Canada

130,000-square-foot Vancouver facility aims to accelerate the development of antibody-based therapies for an array of medical conditions.

06.23.21

Breaking News | Collaborations & Alliances

Cellenkos Chooses Cryoport to Support Covid-19 Therapy Shipments to Patients

Cryoport will provide tracking and proactive management for the therapies.

06.22.21

Breaking News | Industry News | Preclinical Outsourcing

Vectura, Incannex Enter Preclinical Services Agreement

Vectura to provide development services for IHL-216A, Incannex’s inhaled drug product for the treatment of traumatic brain injury.

06.22.21

Breaking News | Clinical Trial Materials | Industry News

CaroGen, BioCentriq Enter Clinical Manufacturing Pact

BioCentriq to provide clinical manufacturing to support Phase 1 clinical trials of CaroGen's lead immunotherapy candidate, CARG-201.

06.22.21

Breaking News | Clinical Trials | CRO News

Syneos Expands Decentralized Trial Capabilities

Aims to accelerate decentralized clinical trial delivery through collaboration with site sponsors.

06.22.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Danaher To Acquire Aldevron for $9.6B

Aldevron will operate as a standalone operating company and brand within Danaher's Life Sciences segment.

06.21.21

Lonza and ValenzaBio Enter Clinical Manufacturing Agreement

Lonza will provide drug substance and drug product manufacturing under accelerated timelines for monoclonal antibody treatment at Guangzhou facility.

06.21.21

Breaking News | Collaborations & Alliances | Drug Development

Jacobio Earns $20M AbbVie Milestone

Initiates Phase 1/2a trial of SHP2 inhibitor JAB-3312 in combination with PD-1 antibody Pembrolizumab and MEK inhibitor Binimetinib.

06.18.21

Breaking News | Collaborations & Alliances | Industry News

KBI Biopharma, AM-Pharma Enter Manufacturing Agreement

Partnership supports future commercial manufacturing for AM-Pharma’s potential kidney disease treatment.

06.17.21

Clinical Trial Materials | Cold Chain Management | Logistics | Supply Chain

Mitigating the Logistical Challenges Associated with Clinical Studies of Investigational Drugs

How Sentry BioPharma Services supports clinical studies with just-in-time custom labeling/kitting/packaging and more.

Contract Pharma Staff

Breaking News | Facilities

Thermo Scientific Upgrades Ultra-Low Temperature Freezers

The TSX Series ULT Freezers reliably preserve stored materials in an environmentally and user-friendly design.

06.16.21

Breaking News | Collaborations & Alliances | Drug Development | Formulation Development

Lumen Bioscience, Novo Nordisk Enter Metabolic Research Pact

To explore Lumen's drug development and manufacturing platform to deliver oral biologics for cardiometabolic disease.

06.16.21

Breaking News | Promotions & Moves | Solid Dosage/Creams/Ointments

Recro Expands Board of Directors

Welcomes Dr. Laura L. Parks to the board.

06.16.21

Dendreon Pharmaceuticals Establishes Contract Manufacturing Division

Now offers end-to-end manufacturing of complex cell therapies and patient logistics for partner programs.

06.15.21

Breaking News | Industry News

GENinCode, EVERSANA Enter Major U.S. Commercialization Pact

EVERSANA will support launch and commercialization in the U.S. market for GENinCode’s portfolio of polygenic cardiovascular disease products.

06.14.21

Capsules | Formulation Development

Formulation of Aqueous Core Poly(lactic acid) Microcapsules

This white paper demonstrates how single-step encapsulation of a water core can be achieved using Adare Pharma Solutions' Stratμm technology.

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Yposkesi to Build Second Commercial Bioproduction Site

Creates a new global resource for cell & gene therapy with production capacity for early clinical to commercially available biologics.

06.14.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

iTeos Therapeutics, GSK Enter Monoclonal Antibody Alliance

GSK now has a leading portfolio of antibodies targeting the CD226 axis, a key target for next-gen immuno-oncology therapies

06.14.21

Enteris BioPharma Receives $10M Milestone from Cara Therapeutics

Third milestone payment related to the development of Oral KORSUVA.

06.11.21

Revolo and Northway Biotech Enter Manufacturing Partnership

To manufacture novel binding immunoglobulin protein, ‘1805, to support phase 2 trials in rheumatoid arthritis and uveitis.

06.11.21

WuXi XDC and LegoChem Ink ADC Agreement

Sign MOU for the development and manufacturing of antibody-drug conjugates.

06.11.21

Vibalogics Expands Manufacturing Capacity

Invests an additional $50 million to further expand cGMP manufacturing capacity for viral vectors.

06.11.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

ProCell for Patient Project to Develop Automated Production Unit for CAR-T Cell Therapies

Standardized and automated manufacturing aims to reduce the amount of work on producing CAR-T cells by 50 percent.

06.10.21

Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates

Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.

CatSci Opens New Dagenham Laboratory

New facility is equipped with state-of-the-art analytical equipment through a collaboration with Shimadzu Corporation.

06.09.21

Yourway Breaks Ground on Major Expansion at Pennsylvania HQ

The project includes a new Phase I clinical trials unit.

06.09.21

Breaking News | Industry News | Promotions & Moves

Symbiosis Names Jette Cowan Biz Development Manager

Will build relationships with new and existing clients across the Nordic region and Germany.

06.09.21

Clinical Trials | CRO News | Industry News | Information Technology

Bioclinica Adds eConsent to EDC Platform

New electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote interactions.

Kristin Brooks 06.08.21

Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News

INOVIO, Advaccine Expand COVID Vax Alliance

To jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 INNOVATE trial evaluating INO-4800 in a two-dose regimen.

Kristin Brooks 06.08.21

Portonbio Enters CAR-T Partnership with KAEDI

CDMO will provide KAEDI with CMC services for multiple projects.

Tim Wright, Editor, Contract Pharma 06.07.21

Bio News | Breaking News | cGMP Manufacture | Facilities | Industry News

Fusion to Build Radiopharma Manufacturing Facility

New 27,000 square foot site will be operational by 2024.

Tim Wright, Editor, Contract Pharma 06.07.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

VIVEbiotech Launches Lentiviral Vectors Mfg. Plant

Increases production capacity by 400% to deliver commercial-size batches for Cell and Gene Therapy Sector.

Kristin Brooks 06.04.21

Facilities | Solid Dosage/Creams/Ointments

Newsmakers: Lynn Allen, Vice President of Business Development, MedPharm

Newly expanded labs bolster testing, formulation development, and manufacturing services.

Tim Wright, Editor, Contract Pharma 06.03.21

Clinical Trials | CRO News | Drug Development | Information Technology

Driving Efficiencies in Today’s Complex Trials

Murray Aitken of IQVIA discusses CRO market trends, post-pandemic opportunities, and leveraging tech-enabled services and capabilities.

Kristin Brooks, Managing Editor, Contract Pharma 06.03.21

Breaking News | Collaborations & Alliances | Industry News

PharmaBlock Sciences Partners with Shouyao Holdings

Will support CMC development and manufacturing of Shouyao’s second-generation ALK inhibitor for non-small cell lung cancer.

Charles Sternberg, Assistant Editor 06.03.21

Breaking News | Industry News

Biovectra Inc. Unveils New Logo and Brand

New image reflects the growing company’s full suite of expertise and core values.

Charles Sternberg, Assistant Editor 06.03.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

Samsung Biologics Signs Agreement with Kahr Medical

Will support Kahr’s drug candidate DSP502, a TIGITxPD1 fusion protein.

Charles Sternberg, Assistant Editor 06.03.21

APIs | Breaking News | cGMP Manufacture | Industry News

Onyx Scientific Receives Commercial API License for UK Facility

Allows Onyx to support API projects from pre-clinical studies to low volume commercial manufacture.

Charles Sternberg, Assistant Editor 06.03.21

Clinical Trials | Drug Development

The Future is Decentralized: What This Means for Clinical Trial Sites

Benefits for research sites and how to prepare for decentralized trials.

Marc Leighton, Vice President of Product at Florence Healthcare 06.02.21

Breaking News | Fill/Finish | Industry News

Selkirk Pharma Begins Construction of Injectable Mfg. Facility in Spokane

New fill and finish facility will add critically needed capacity for the manufacture of commercial and clinical trial drugs.

Kristin Brooks 06.02.21

Breaking News | Collaborations & Alliances

Aptamer Group Collaborates with PinotBio

Will work together to develop new therapeutic drug conjugates.

Charles Sternberg, Assistant Editor 06.02.21

Breaking News | Drug Delivery | Facilities | Industry News | Solid Dosage/Creams/Ointments

MedPharm Opens New Manufacturing Facility

State-of-the-art facility in Durham, NC expands the CDMO’s topical and transdermal delivery capabilities.

Tim Wright, Editor, Contract Pharma 06.01.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

CCRM Enters Regenerative Medicine Partnerships

Signs agreements with Canadian and international institutions to advance regenerative medicine inventions.

Tim Wright, Editor, Contract Pharma 06.01.21

Breaking News | Cold Chain Management | Industry News | Packaging & Tracking

Cryoport Systems and CRYOPDP Jointly Open Global Logistics Center

The Singapore location is another step in Cryoport's strategy to strengthen its footprint in the Asia Pacific region.

Charles Sternberg, Assistant Editor 05.27.21

Breaking News | Industry News | Promotions & Moves

ACG Appoints Senior Executives in Europe

Daniel Illmer and Afsaneh Nakhavoli join the company’s R&D facility in Germany.

Charles Sternberg, Assistant Editor 05.27.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

The Discovery Labs Signs Lease with UPenn's Gene Therapy Program

The University will use Discovery Labs’ campus for a portion of its research operations focused on the development of genetic medicines.

Charles Sternberg, Assistant Editor 05.27.21

Breaking News | cGMP Manufacture | Collaborations & Alliances

Ori Biotech and Vineti Enter Non-Exclusive Partnership

Will produce a fully pre-integrated solution to modernize, fast-track, and streamline the manufacture and delivery of cell and gene therapies.

Charles Sternberg, Assistant Editor 05.26.21

Biologics, Proteins, Vaccines | Clinical Trials | Drug Development

Gene Therapy Trials

Critical regulatory and study start-up questions for gene therapy trials in the U.S., UK, and Europe.

April Marquick, Cell and Gene Therapy Expert, Premier Research 05.26.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

MilliporeSigma Accelerates Scale Up of Lipids to Meet Covid Demand

One of a few companies that produces lipids in quantities needed to meet demand for mRNA therapeutics, including Pfizer-BioNTech Covid-19 vaccine.

Kristin Brooks 05.26.21

Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Cambrex Adds Kilogram-Scale Mfg. Capabilities at Estonia

Building work and installation of the new reactor and supporting equipment is now complete, and preparation for GMP qualification is underway.

Kristin Brooks 05.26.21

Analytical Services | Breaking News | Facilities | Industry News | Laboratory Testing

Almac Sciences Invests in Continuous Flow Chemistry Equipment

Furthers its most recent laboratory expansion.

Charles Sternberg, Assistant Editor 05.25.21

APIs | Cytotoxics and High Potency Manufacturing | Formulation Development | Process Development

Solubility Enhancement of Hydrophobic Drugs and APIs Using Hot Melt Extrusion

Efficient processing and production technology for solid molecular dispersion, HME can provide sustained, modified and targeted drug delivery.

Ameya Deshpande, Formulation Scientist, Avomeen 05.25.21

Clinical Trials | Drug Development | Information Technology

Clinical Development Trends

Digital modernization, decentralized trials, and advanced therapies drive outsourcing of clinical trials.

Kristin Brooks, Managing Editor, Contract Pharma 05.25.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

CanSino Biologics Gets OGYÉI GMP Certificate for COVID Vax

Convidecia has been approved in China, Mexico, Pakistan, Hungary and Chile.

Kristin Brooks 05.24.21

Breaking News | CRO News | Industry News

Premier Research Acquires Camargo Pharmaceutical Services

Expands product planning, development and differentiation services offered.

Tim Wright, Editor, Contract Pharma 05.21.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Drug Development

Thermo Fisher, UCSF to Open Cell Therapy cGMP Mfg. Center

Thermo Fisher will build and operate a 44,000-sq.-ft. cell therapy development, manufacturing and collaboration center on UCSF's Mission Bay campus.

Kristin Brooks 05.20.21

Breaking News | Industry News

ACG Wins iF Award for ‘Karton X’

Karton X is a high-speed cartoner with an output of 300 items per minute.

Charles Sternberg, Assistant Editor 05.19.21

Breaking News | Collaborations & Alliances | Industry News

Univercells Technologies Collaborates with NIBRT

Adds scale-X carbo integrated system at Dublin facility for intensified upstream viral manufacturing demonstrations and training.

Charles Sternberg, Assistant Editor 05.19.21

Breaking News | Clinical Trial Materials | Industry News | Promotions & Moves

Sharp Appoints Robert O’Beirn to Its Global Clinical Services Business

Names O’Beirn as SVP and managing director.

Charles Sternberg, Assistant Editor 05.19.21

Colorcon Adds New Containment Suite in Its Global Headquarters

Expands its technical service capabilities.

Charles Sternberg, Assistant Editor 05.19.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News

Gamma Biosciences Acquires Stake in Mirus Bio

Supports Mirus’ expansion of GMP production of its flagship product TransIT VirusGEN for large scale manufacturing of AAV and LV viral vectors for gene therapy.

Kristin Brooks 05.18.21

Breaking News | Promotions & Moves

Centogene Appoints Dr. Michael Motz as CCO

Motz is an entrepreneur and executive with over 25 years of industry experience.

Charles Sternberg, Assistant Editor 05.18.21

Breaking News | Drug Development | Formulation Development | Industry News | Solid Dosage/Creams/Ointments

Recro, Astex Enter Drug Development Alliance

Expands partnership for oral solid dose drug product services.

Kristin Brooks 05.18.21

R&D Alliance for Eye Disease Cell Therapies

BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases.

Tim Wright, Editor, Contract Pharma 05.17.21

BioMedX Extends Collaboration with Merck

Merck will support up to six more research groups at the BioMed X Institute in Heidelberg within the next six years.

Charles Sternberg, Assistant Editor 05.17.21

Breaking News | Collaborations & Alliances | Industry News

Zynrelef Anesthetic Receives FDA Approval

Lifecore will manufacture the new innovative drug for treatment of postoperative pain.

Charles Sternberg, Assistant Editor 05.17.21

Humanigen Selects Chime Biologics as Manufacturing Partner

Ink manufacturing deal for COVID-19 therapeutic candidate lenzilumab.

Tim Wright, Editor, Contract Pharma 05.17.21

Summit for Clinical Ops Executives

...

05.13.21

Breaking News | Cytotoxics and High Potency Manufacturing | Facilities | Industry News

Novasep Expands HPAPI Manufacturing Capacity

Responds to increasing customer demand for manufacturing services for antibody drug conjugates.

Tim Wright, Editor, Contract Pharma 05.13.21

Breaking News | Facilities | Industry News

Quadpack Invests €4 Million in Smart Manufacturing

Says efficiency, high technology and sustainability are at the core of its regional operational strategy.

Charles Sternberg, Assistant Editor 05.13.21

Breaking News | Promotions & Moves

New Amsterdam Sciences Appoints Executive Vice President

Dr. Christopher van de Wetering brings decades of governmental experience.

Charles Sternberg, Assistant Editor 05.12.21

Breaking News | Industry News

HBC, Catalent Enter Innovative Softgel Alliance

Partnership will leverage Catalent’s OptiGel DR technology to develop a delayed-release formulation of HBC’s OmeGo fish oil.

Kristin Brooks 05.12.21

Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Northwest Bio Seeks GMP Certification of Sawston Mfg. Facility

Upon initial license, production of GMP DCVax-L products in the Sawston facility may begin by the end of Q3.

Kristin Brooks 05.12.21

Breaking News | Promotions & Moves

Capsida Biotherapeutics Appoints CMO

Dr. Tole brings extensive drug development experience in the biotech industry across a wide spectrum of disease areas.

Kristin Brooks 05.12.21

Breaking News | Clinical Trials | CRO News

Emmes Acquires Orphan Reach

Establishes Emmes as an industry leader in clinical research for orphan and rare diseases.

Kristin Brooks 05.12.21

Breaking News | Facilities | Industry News

Parker Bioscience Filtration Expands Capabilities

Makes investment at its Birtley, UK site and helps to support vaccine production in EMEA.

Charles Sternberg, Assistant Editor 05.11.21

Enteris BioPharma Completes Expansion of Manufacturing Facility

Also launches CDMO business for the development and manufacture of difficult to formulate drugs and highly potent compounds.

Tim Wright, Editor, Contract Pharma 05.11.21

Analytical Services | Breaking News | Facilities | Industry News | Laboratory Testing

Cambrex Expands Analytical Services Capabilities

Adds 1,800 square feet of lab space at Longmont, CO facility.

Tim Wright, Editor, Contract Pharma 05.11.21

Breaking News | Industry News | Promotions & Moves

Woodstock Sterile Solutions Names Oliver Vogt as VP and General Manager

Will be responsible for Woodstock’s manufacturing business as well as leading its supply chain and site operations.

Charles Sternberg, Assistant Editor 05.11.21

Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

OncoTEX, Sterling Pharma Sign Clinical Mfg. Pact

Sterling will produce clinical material for OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.

Kristin Brooks 05.10.21

Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings

INOVIO’s DNA COVID Vax Achieves Positive Results

Phase 2 clinical trial shows INO-4800 was generally safe, well-tolerated and immunogenic in all studied age groups.

Kristin Brooks 05.10.21

Bio News | Breaking News | Collaborations & Alliances | Drug Development | Industry News

3P and Buzzard Pharmaceuticals Enter Cancer Collaboration

Enter into a partnership agreement for manufacturing of the potent IL-1 inhibitor Isunakinra.

Charles Sternberg, Assistant Editor 05.07.21

Bio News | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News

AGC Biologics and Oculis Enter Manufacturing Deal

AGC to manufacture Oculis’ OCS-02 at its Heidelberg facility.

Tim Wright, Editor, Contract Pharma 05.07.21

APIs | Breaking News | Collaborations & Alliances | Cytotoxics and High Potency Manufacturing | Industry News

FDA Approves ADC Therapeutics' Zynlonta

ADC collaborated with CDMO Sterling Pharma Solutions to develop the cancer drug.

Tim Wright, Editor, Contract Pharma 05.07.21

Breaking News | Industry News

Altasciences Acquires Calvert Laboratories

Now has presence on U.S. East Coast; increases small molecule expertise.

Tim Wright, Editor, Contract Pharma 05.07.21

Breaking News | Drug Development | R&D

Crown Bioscience Acquires OcellO

Expands its portfolio of in vitro services.

Charles Sternberg, Assistant Editor 05.06.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Novavax, Gavi Execute APA for COVID-19 Vax

Novavax to deliver 350 million doses beginning 3Q21.

Kristin Brooks, Contract Pharma 05.06.21

Clinical Trials | Logistics | Supply Chain

LabConnect, Cryoport Partner to Support Triumvira Trial Logistics

Will integrate Cryoport's Cryoportal Logistics Management Platform and LabConnect's SampleGISTICS platform to provide Triumvira with advanced logistics support.

Kristin Brooks, Contract Pharma 05.06.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances

ADC Therapeutics Receives FDA Approval for Zynlonta

ADC collaborated with Sterling Pharma Solutions to develop Zynlonta.

Charles Sternberg, Assistant Editor 05.06.21

Breaking News | Drug Delivery | Drug Development | Industry News

Vectura, Inspira Partner to Develop Inhaled COVID Treatment

Further testing and development work to prepare for Phase 1 studies using its FOX vibrating mesh nebulizer to deliver IPX formulations.

Kristin Brooks, Contract Pharma 05.06.21

The Word ‘Innovation’ Probably Doesn’t Mean What You Think It Does

Innovation in manufacturing can come in many forms.

Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 05.05.21

Analytical Services

Too Much of a Good Thing?

Watch out for that pendulum!

Emil W. Ciurczak, DoraMaxx Consulting 05.05.21

CDMO Market Trends & Opportunities

CDMOs have been some of the biggest winners from COVID contracts and will see benefits for several more years to come. A Q&A with GlobalData’s Peter Shapiro.

Tim Wright, Editor, Contract Pharma 05.05.21

Fast Track Automation in Pharmaceutical Manufacturing

Drug manufacturers turn to advanced automation technologies and project execution methodologies to reduce time, cost and risk.

Steve Zarichniak, Technical Solutions Consultant, Honeywell Process Solutions 05.05.21

Small Molecule Drug Development Trends

Lonza’s Robert Beland discusses best practices for manufacturers to shorten development timelines, as well as some of the capabilities at the CDMO's Tampa site.

Tim Wright, Editor, Contract Pharma 05.05.21

Breaking News | Industry News

Multivac Unveils State of the Art Logistics Center

Invested $11.2M in facility at its U.S. headquarters in Kansas City.

Tim Wright, Editor, Contract Pharma 05.05.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

BioVaxys Inks Deal with CDMO BioElpida

Includes clinical-grade bioproduction and aseptic packaging for ovarian cancer vaccine candidate BXV-0918A.

Tim Wright, Editor, Contract Pharma 05.05.21

Bio News | Breaking News | Industry News

Cellares Expands Cell Therapy Manufacturing Capabilities

Raises $82M to accelerate development of the Cell Shuttle scalable factory-in-a-box.

Tim Wright, Editor, Contract Pharma 05.05.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Clean Biologics Acquires Biodextris

To establish North American presence and expand activities with Biodextris’ complementary services.

Tim Wright, Editor, Contract Pharma 05.05.21

Breaking News | Drug Development | Industry News

Exelixis Acquires GamaMabs Oncology Antibody Program

Gains AMHR2 franchise technology including all assets pertaining to GamaMabs’ monoclonal antibody drug product murlentamab.

Kristin Brooks 05.04.21

Breaking News | Clinical Trials | CRO News | Information Technology

Syneos, Komodo Health Expand Data App Alliance

Leveraging Komodo’s Healthcare Map, Syneos aims to better analyze clinical, real-world, and commercial data.

Kristin Brooks 05.04.21

Clinical Trials | Information Technology | Promotions & Moves

Clinical Ink Adds Executives

CCO Chris Crucitti, COO Brian Donahue, and VP Project Operations Bill Barrasso to manage eSource platforms.

Kristin Brooks 05.04.21

Breaking News | cGMP Manufacture | Industry News | Information Technology

Autolomous to Expedite Digitization of Batch Verification

Will work to develop AutoloMATE-Assist, a digital batch verification technology for cell and gene therapies to alleviate paper based bottlenecks.

Kristin Brooks 05.04.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Moderna to Increase Global Supply for COVID-19 Vaccine

Will supply up to 3 billion doses in 2022 and double supply from ex-U.S. supply chain.

Tim Wright, Editor, Contract Pharma 05.03.21

AbCellera Breaks Ground on Global HQ in Vancouver

380,000 square feet of facilities envisioned as creative tech hub expected to be completed in 2023 and 2024.

Tim Wright, Editor, Contract Pharma 05.03.21

Bio News | Breaking News | Facilities | Industry News

NuvOx Completes Construction of Expanded Manufacturing Facility

Will manufacture its lead product, NanO2, for clinical trials and commercial supply after FDA approval.

Tim Wright, Editor, Contract Pharma 05.03.21

AMRI Adds R&D and Mfg. Solutions for Orphan Products

Targeted investments globally expand scale and compound handling capabilities at facilities in Albany, Grafton, and Glasgow.

Kristin Brooks 04.30.21

Breaking News | Industry News | Promotions & Moves

Frontage Laboratories Appoints Executive Director, Regional Head of Sales, West

John Foster will be accountable for overseeing business development efforts in the western US.

Charles Sternberg, Assistant Editor 04.29.21

Breaking News | Facilities | Fill/Finish | Industry News

Grand River Aseptic Manufacturing Earns Facility of the Year Award

Receives special recognition for operational agility during the pandemic.

Charles Sternberg, Assistant Editor 04.29.21

Breaking News | Facilities | Industry News | Packaging & Tracking

Bushu Pharma Establishes Packaging Center

Expands its gateway to Asia services in partnership with Chuo Unyu Company.

Charles Sternberg, Assistant Editor 04.29.21

PPD to Expand GMP Lab in Ireland

Adding cell and gene therapy capabilities to support growing customer need.

Tim Wright, Editor, Contract Pharma 04.29.21

Breaking News | Cold Chain Management | Collaborations & Alliances | Industry News | Packaging & Tracking

Catalent and Stirling Ultracold Enter Cold Chain Partnership

To establish energy-efficient cold chain capabilities for biologics and emerging modalities.

Tim Wright, Editor, Contract Pharma 04.29.21

ADMA Receives FDA Approval for Increased IVIG Production Scale

Increases plant manufacturing capacity from 400,000L to 600,000L.

Tim Wright, Editor, Contract Pharma 04.29.21

Breaking News | cGMP Manufacture | Clinical Trial Materials

Precirix Partners with Evergreen Theragnostics

Evergreen will provide US-based manufacturing for Precirix's lead product candidate, CAM-H2.

Charles Sternberg, Assistant Editor 04.28.21

Clinical Trials | CRO News | Information Technology

PPD, Science 37 Partner to Advance Decentralized Trials

PPD will leverage Science 37's DCT SaaS-based technology platform to design, build, test, implement and execute digital trials.

Kristin Brooks 04.28.21

Breaking News | cGMP Manufacture | Industry News

FDA Approves ADMA Biologics Increased IVIG Production

Expanded manufacturing process enables fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin.

Kristin Brooks 04.28.21

Breaking News | Drug Development

Silo Pharma Enters Joint Venture with Zylo Therapeutics

Will explore the clinical development of ketamine and psilocybin using ZTI’s Z-pod technology.

Charles Sternberg, Assistant Editor 04.28.21

Biologics, Proteins, Vaccines | Breaking News

Introducing ViroCell Biologics

The UK’s first clinical trial focused viral vector manufacturer.

Charles Sternberg, Assistant Editor 04.28.21

Breaking News | Facilities | Industry News

Sharp Expanding with Third Pennsylvania Location

Gov. Wolf announces packaging manufacturer bringing hundreds of new jobs to Lehigh Valley Region.

Tim Wright, Editor, Contract Pharma 04.27.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Bristol Myers Squibb Invests in Cell Therapy Ops

New manufacturing site planned in the Netherlands is the company’s fifth facility dedicated to cell therapy.

Tim Wright, Editor, Contract Pharma 04.27.21

Breaking News | cGMP Manufacture | Industry News | Scale-up/Technology Transfer

Asher Bio, ProBioGen Ink Development, Mfg. Agreement

ProBioGen to provide cell line development, process development and GMP manufacturing at 1000 L bioreactor scale of Asher's lead immuno-oncology candidate.

Kristin Brooks 04.26.21

Breaking News | Promotions & Moves

GT Biopharma Appoints Gregory Berk CMO

Jeffrey S. Miller, M.D. will become Consulting Chief Scientific Officer, continuing to lead TriKE product candidate clinical trials.

Kristin Brooks 04.26.21

Breaking News | Facilities | Industry News

Lonza to Build Small Molecule Manufacturing Complex in Visp

Will invest $220 million to construct the complex that will include a manufacturing line for antibody-drug conjugate payload molecules.

Tim Wright, Editor, Contract Pharma 04.23.21

Breaking News | Collaborations & Alliances | Drug Development | Formulation Development

Nanoform, Aprecia Partner to Advance 3DP Nanomedicines

To explore synergies between their respective technologies in the field of nanoparticle-enabled 3DP dosage forms.

Kristin Brooks 04.22.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Valneva Focuses on Bilateral Discussions to Supply COVID-19 Vax

Looks to secure a supply agreement for the only inactivated vaccine candidate in clinical trials against COVID-19 in EU.

Kristin Brooks 04.22.21

Clinical Trials | CRO News | Information Technology

Syneos, Medable Partner for New Decentralized Capabilities

Aims to increase clinical trial diversity and improve patient access and experiences with fit-for-purpose decentralized digital solution.

Kristin Brooks 04.22.21

Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings

Valneva’s Inactivated, Adjuvanted COVID-19 Vax Achieves Positive Data

VLA2001 was highly immunogenic with more than 90% of study participants developing significant levels of antibodies to SARS-CoV-2 virus spike protein.

Kristin Brooks 04.22.21

Bio News | Breaking News | Industry News

Frontage Acquires Ocean Ridge Biosciences

Expands genomics services through the acquisition deal.

Tim Wright, Editor, Contract Pharma 04.21.21

Bio News | Breaking News | Collaborations & Alliances | Drug Development | Industry News

AGC Biologics Expands Partnership with Rocket Pharmaceuticals

AGG will bolster supply across Rocket’s lentiviral vector (LVV) pipeline, with the manufacture of LVV.

Tim Wright, Editor, Contract Pharma 04.21.21

Breaking News | Industry News

Revolo Biotherapeutics, CordenPharma Enter Master Service Agreement

Will scale up and manufacture ‘1104 for the treatment of eosinophilic esophagitis and allergic disease.

Charles Sternberg, Assistant Editor 04.19.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Resilience Acquires Ology Bioservices

Continues expansion with acquisition of biologics manufacturing company.

Tim Wright, Editor, Contract Pharma 04.19.21

Breaking News | Collaborations & Alliances | Industry News

Kintor, Visum Enter COVID-19 Manufacturing Partnership

To expand proxalutamide manufacturing for treatment of COVID-19 patients.

Tim Wright, Editor, Contract Pharma 04.19.21

Breaking News | Drug Development | Industry News

Evotec Enters Master Service Agreement with Kazia Therapeutics

Will work together to make EVT801 available to patients globally.

Charles Sternberg, Assistant Editor 04.19.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Sartorius Expands in the UK

New 58,000-square-foot facility aims to simplify and accelerate the production of downstream processing equipment.

Kristin Brooks 04.16.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Abenza Chooses North Carolina for New Biologics Manufacturing Site

GMP manufacturing will commence in mid-2022.

Charles Sternberg, Assistant Editor 04.15.21

Catalent Adds Cryogenic Capabilities at Philadelphia Facility

Bolsters clinical supply services at site to meet growing demand for cell and gene therapy development.

Tim Wright, Editor, Contract Pharma 04.15.21

Breaking News | CRO News | Industry News

Thermo Fisher Acquires PPD for $17.4B

Further expands service offering to pharma and biotech customers.

Tim Wright, Editor, Contract Pharma 04.15.21

Breaking News | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments

Recro, Ensysce Expand Development and Manufacturing Partnership

Additional contract broadens and further strengthens customer product portfolio.

Tim Wright, Editor, Contract Pharma 04.15.21

Breaking News | Clinical Trial Materials | Industry News | Promotions & Moves | Solid Dosage/Creams/Ointments

Metrics Names Stephanie Emory Associate Director of Pharma Development

Will direct team of formulation scientists who develop oral solid dose formulations for Phase I through Phase III clinical trials.

Tim Wright, Editor, Contract Pharma 04.15.21

Breaking News | Drug Development | Industry News

BioVersys Gets EIB Funds to Address Antimicrobial Resistance

Financing supports development of BioVersys’ breakthrough hospital antibiotic therapy targeting Acinetobacter baumannii

Kristin Brooks 04.14.21

Breaking News | Promotions & Moves

Executive Moves: Novavax

Gale Smith named SVP, Discovery and Pre-Clinical Research and Chief Scientist, and Troy Morgan named SVP, Chief Compliance Officer.

Kristin Brooks 04.14.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Catalent Biologics Completes Madison Expansion

More than doubles overall CGMP-scale capacity increasing the number of manufacturing suites at the site to five.

Kristin Brooks 04.13.21

Breaking News | Industry News | Microbiology

Lonza Expands PyroTec PRO for Endotoxin Testing

Aims to enable users to streamline and improve the performance of the QC laboratory, increasing lab efficiency and productivity.

Kristin Brooks 04.12.21

Breaking News | Clinical Trials | Drug Development | Trials & Filings

FDA Accepts Airway Therapeutics’ IND for COVID Treatment

To initiate a Phase 1b trial to confirm the feasibility of intratracheal administrations of AT-100 and its beneficial safety and tolerability profile.

Kristin Brooks 04.12.21

Analytical Services | Breaking News | Clinical Trial Materials | Drug Development | Industry News

Ascendia Pharmaceuticals Poised for Expansion

CDMO secures growth equity investment from Signet Healthcare Partners.

Tim Wright, Editor, Contract Pharma 04.09.21

Breaking News | Clinical Trials | CRO News | Industry News

Frontage Expands Capabilities at its Clinical Site in Secaucus, NJ

Offers full-service human absorption, metabolism, and excretion (hAME) studies with radiolabeled compounds.

Tim Wright, Editor, Contract Pharma 04.09.21

Analytical Services | Bioanalytical Services | Breaking News | Industry News

Agilex Biolabs Acquires TetraQ for APAC Expansion Plans

Specializes in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarker and immunological pharmacodynamics assessments.

Kristin Brooks 04.08.21

Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News

Alkermes, Merck Enter Clinical Trial and Supply Agreement

To evaluate nemvaleukin alfa in combination with Keytruda in patients with platinum-resistant ovarian cancer.

Tim Wright, Editor, Contract Pharma 04.07.21

Hitachi, Axcelead to Develop Next-Gen Biopharmaceuticals

Supporting R&D optimization of next-generation biopharmaceuticals with digital technology and drug discovery platform.

Tim Wright, Editor, Contract Pharma 04.07.21

Breaking News | Collaborations & Alliances | Drug Delivery | Drug Development | Industry News

Kindeva Drug Delivery and Cambridge Healthcare Innovations Collaborate

Work together to develop and commercialize CHI’s novel dry-powder inhaler product.

Charles Sternberg, Assistant Editor 04.07.21

Breaking News | Clinical Trials | Drug Development | Industry News

Sound Pharmaceuticals Receives $3.1M NIH Grant for COVID Treatment

To support the testing of SPI-1005 in two Phase 2 clinical trials for the treatment of COVID-19.

Kristin Brooks 04.06.21

Breaking News | Clinical Trials | CRO News | Drug Development

Moleculin Selects IQVIA Biotech to Advance COVID Treatment

IQVIA to manage the company's effort to begin potential clinical trials of WP1122 for the treatment of COVID-19.

Kristin Brooks 04.06.21

Breaking News | Cold Chain Management | Industry News | Logistics | Supply Chain

Cryoport Acquires Critical Transport Solutions Australia

Further expands Cryoport's presence in Asia-Pacific region to address increased clinical trial activity.

Kristin Brooks 04.06.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Fill/Finish | Industry News

Moderna, Catalent Enter Long-Term Strategic Vax Pact

Catalent to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs.

Kristin Brooks 04.06.21

Solid Dosage/Creams/Ointments | Solid Dosage/Semi-solids

PharmParts – This Makes Sense!

5 reasons to consider purchasing secondhand parts.

Justin Kadis, Business Development, Federal Equipment 04.06.21

Breaking News | Industry News | Promotions & Moves

Recro Pharma Expands Business Development Team

Adds six new members, including sales representatives and regional representatives.

Charles Sternberg, Assistant Editor 04.05.21

Sanofi to Build New $700M Flu Vaccine Facility in Canada

Facility will be located in Toronto and will increase supply of influenza vaccines in Canada, the U.S. and Europe.

Tim Wright, Editor, Contract Pharma 04.05.21

Breaking News | Collaborations & Alliances | Industry News

CordenPharma Enters Alliance with Nanos of South Korea

Partnership represents Nanos’ intention to establish long-term production and sale of therapeutic drugs involving peptides.

Tim Wright, Editor, Contract Pharma 04.05.21

Breaking News | Industry News | Information Technology

LabVantage Solutions Expands and Improves its Portfolio

Unveils two new solutions and an updated version of its flagship LIMS platform.

Charles Sternberg, Assistant Editor 04.05.21

Breaking News | Excipients | Facilities | Industry News

Crystec Launches New R&D Center in China

New site in Haimen, Jiangsu province has been established following an invitation to participate in the Yangtze Delta Advanced Drug Development platform.

Tim Wright, Editor, Contract Pharma 04.05.21

Biologics, Proteins, Vaccines | Regulatory Affairs

What Will Change at FDA for 2021?

(R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?

Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21

Clinical Trials | Drug Development | QA/QC

RBQM Comes of Age: COVID as a Catalyst for Change

Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.

Kristin Brooks, Managing Editor 04.01.21

Breaking News | Drug Development

Servier Acquires Agios Pharmaceuticals’ Oncology Portfolio

Expands its oncology leadership capabilities in the U.S.

Charles Sternberg, Assistant Editor 04.01.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Eloxx Pharmaceuticals Acquires Zikani Therapeutics

Combined company brings complementary Ribosomal RNA-targeted genetic therapy platforms together.

Kristin Brooks 04.01.21

Breaking News | Industry News

Lonza Completes Divestment of Sites to NextPharma

Lonza exits both softgels and liquid-filled hard capsules and NextPharma plans to broaden its technology offering into lipid based finished dosage forms.

Kristin Brooks 04.01.21

Enteris BioPharma: Custom Solutions – From Bench to Market

CDMO operations are housed within a 32,000-square-foot, FDA-inspected and cGMP-compliant facility in northern New Jersey.

Clinical Trial Materials | Drug Development | Formulation Development

On-Demand Webinar: Accelerated Timelines for Clinical Supply Manufacture

Watch this on-demand webinar to gain a deeper understanding of the value of adaptive processes at this critical early stage of drug development.

Breaking News | Industry News

SK Capital Completes Acquisition of BFS from Catalent Pharma Solutions

Renames the business to Woodstock Sterile Solutions.

Charles Sternberg, Assistant Editor 03.31.21

Breaking News | Industry News | Promotions & Moves

Rentschler Biopharma Names Martin Kessler as New CEO in U.S.

Will drive company-wide transformation and lead the ongoing expansion at the U.S. site.

Tim Wright, Editor, Contract Pharma 03.31.21

GSK Supports Manufacture of Novavax’ COVID-19 Vaccine

GSK will provide fill and finish manufacturing capacity for up to 60 million doses at its Barnard Castle facility.

Tim Wright, Editor, Contract Pharma 03.31.21

Breaking News | cGMP Manufacture | Fill/Finish | Industry News

GRAM Attains EU GMP Certification for Commercial Aseptic Fill/Finish

Recognizes manufacturing facility and processes are in compliance with GMP requirements and readiness to provide commercial aseptic fill/finish services.

Kristin Brooks 03.30.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Ajinomoto, Bright Peak Enter Immunocytokines Research Pact

Exclusive license agreement to incorporate Ajinomoto Co.’s AJICAP site-specific bioconjugation technology for the development of Bright Peak Immunocytokines.

Kristin Brooks 03.30.21

Biologics, Proteins, Vaccines | cGMP Manufacture

Advanced Analytics Advancing Development of Genetic Vaccines

Leveraging innovative advanced analytical technologies to ensure regulatory compliance in the development and production of novel vaccines.

Kristin Brooks, Managing Editor, Contract Pharma 03.29.21

Chime Biologics Expands CDMO Capabilities

Completes $190 million financing round to accelerate capacity expansion.

Tim Wright, Editor, Contract Pharma 03.29.21

cGMP Manufacture | Drug Development | Scale-up/Technology Transfer

Fast Track Automation in Pharmaceutical Manufacturing

Drug manufacturers turn to advanced automation technologies and project execution methodologies to reduce time, cost and risk

Steve Zarichniak, Technical Solutions Consultant, Honeywell Process Solutions 03.25.21

CyanVac and Exothera Enter COVID-19 Vaccine Partnership

CDMO Exothera selected for the development and GMP manufacturing of intranasal vaccine candidate for Phase III clinical trial is Europe and the U.S.

Tim Wright, Editor, Contract Pharma 03.25.21

Breaking News | R&D

JSR Life Sciences Unveils Corporate Venture Fund

Aims to foster investment in new companies and innovative technologies.

Charles Sternberg, Assistant Editor 03.24.21

Clinical Trials | CRO News | Information Technology

PPD, Clinical Ink Partner on Near Real-Time Access to Endpoint Data

Jointly develop systemic lupus erythematosus assessment review process to enhance data quality and research site personnel experiences and efficiencies.

Kristin Brooks 03.24.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News | Process Development

ProBioGen, Nobelpharma Enter Mfg. Agreement for Vax Project

To leverage ProBioGen’s vaccine development platform consisting of its AGE1.CR.pIX suspension cell line and its high performance cell culture medium.

Kristin Brooks 03.24.21

Breaking News | cGMP Manufacture | Formulation Development | Industry News

Piramal Pharma Solutions, Plus Therapeutics Ink MSA  

Piramal to perform services related to the development, manufacture, and supply of Plus Therapeutics’ RNL-Liposome Intermediate Drug Product.

Kristin Brooks 03.24.21

Breaking News | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer

Plus Therapeutics, Piramal Ink Master Services Agreement

Development, manufacturing and supply deal is for Plus’ Rhenium NanoLiposome intermediate drug product.

Tim Wright, Editor, Contract Pharma 03.23.21

Breaking News | Facilities | Industry News

Raybow Pharmaceutical Expands in U.S.

China-based CDMO will invest $15.8 million in North Carolina facility.

Tim Wright, Editor, Contract Pharma 03.23.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery

Evotec, Takeda Enter Multi-RNA Target Alliance

To discover and develop small molecule therapeutics for highly attractive targets that are difficult to address via more conventional approaches.

Kristin Brooks 03.22.21

Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Trials & Filings

CureVac Expands Late-stage Trials of COVID Vax Candidate

Further analysis to determine efficacy of the vaccine candidate for new virus variants.

Krisitn Brooks 03.22.21

Clinical Trials | Drug Development

Regulatory Practices in a Post-Pandemic World

Envisioning the new normal for clinical development.

Dr. Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 03.22.21

Biologics, Proteins, Vaccines | Breaking News | Industry News | Scale-up/Technology Transfer

SpyBiotech Licenses Selexis’ SUREtechnology for HCMV Vax

Will leverage SUREtechnology Platform to generate stable, high-yield production cell lines needed for human clinical trials.

Kristin Brooks 03.18.21

WuXi Biologics to Acquire CMAB Biopharma Group

Will increase 7000L drug substance capacity (MFG21) and drug product capacity (DP11) for liquid and lyophilization within its global manufacturing network.

Kristin Brooks 03.18.21

Breaking News | Industry News

Romaco Acquires STE Tecpharm

Strengthens Romaco’s processing business with Tecpharm’s drum coaters, coupled with conventional granulation lines and Wurster fluid bed systems.

Kristin Brooks 03.18.21

Breaking News | Clinical Trials | Drug Development | Trials & Filings

Gilead, Novo Nordisk Expand NASH Alliance

Phase II trial to investigate Novo’s semaglutide and a combination of Gilead’s cilofexor and firsocostat, alone and in combination in cirrhosis due to NASH.

Kristin Brooks 03.18.21

Promotions & Moves

Alcami Appoints Patrick D. Walsh as Chairman and Chief Executive Officer

He succeeds Walter J. Kaczmarek III, who is stepping down as Chief Executive Officer.

Bio News | Breaking News | Collaborations & Alliances | Industry News

Fujifilm and Sana Biotechnology Enter Cell Therapy Partnership

Enter license agreement for the development of iPSC-derived cell therapies.

Tim Wright, Editor, Contract Pharma 03.17.21

Breaking News | Clinical Trial Materials | Cold Chain Management | Industry News

PCI Pharma Services Expands Cold Chain Clinical Supply Storage

Adds significant capacity and several new cold chain storage conditions, which now include temperatures from controlled room temperature to -80°C.

Kristin Brooks 03.16.21

Breaking News | Clinical Trial Materials | CRO News

LabConnect Expands Johnson City Facility

Central lab to add 20,000 sq.-ft., tripling kit building capacity for complex clinical studies along with other planned operational improvements.

Kristin Brooks 03.16.21

Breaking News | Clinical Trials | Drug Development | Trials & Filings

Cytocom Gets FDA Clearance for Phase II Trial of COVID Immune Therapy

Phase 2 clinical trial to evaluate the safety and efficacy of CYTO-205 as a treatment to slow or halt the progression of SARS-CoV-2.

Kristin Brooks 03.16.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Tevogen Bio, BioCentriq Partner for COVID T-cell Therapy

NJ-based cell and gene therapy development and manufacturing center to support clinical manufacturing of Tevogen’s investigational COVID-19 treatment.

Kristin Brooks 03.16.21

Breaking News | Collaborations & Alliances | Industry News | Parenterals | Solid Dosage/Creams/Ointments

Gilead and Merck Ink HIV Agreement

Collaboration to focus on oral and injectable formulations of lenacapavir and islatravir.

Tim Wright, Editor, Contract Pharma 03.15.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Maravai Expands CDMO Capabilities Through TriLink Biotechnologies

Offers end-to-end mRNA production with the launch of TriLink's plasmid DNA manufacturing services.

Tim Wright, Editor, Contract Pharma 03.15.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

BioVaxys, Wuxi Biologics Enter Bioproduction Agreement

To synthesize proteins for SARS-CoV-2 vaccine and COVID-T immunodiagnostic programs.

Tim Wright, Editor, Contract Pharma 03.15.21

Cytotoxics and High Potency Manufacturing | Facilities | Solid Dosage/Creams/Ointments

Outsourcing Solid Dosage Manufacturing

A Q&A with Dan Dobry, head of drug product commercial development at Lonza Pharma & Biotech.

Tim Wright, Editor, Contract Pharma 03.12.21

Breaking News | cGMP Manufacture | Industry News

Altimmune, Lonza Expand AdCOVID Manufacturing Pact

Lonza to commission a dedicated suite for clinical and commercial supply of Altimmune’s COVID-19 vaccine candidate at its Houston facility.

Kristin Brooks 03.12.21

Clinical Trials | Information Technology

The Evolution of Clinical Research Technology to Support Remote Collaboration

Pioneering change with technology advancements that yield high reward with tolerable risk.

Angela Gill Nelms, COO for Florence Healthcare 03.11.21

Breaking News | Industry News

ANI Pharmaceuticals Strengthens CDMO Business

Acquisition of Novitium Pharma for $163.5 million also bolsters R&D engine and generics portfolio.

Tim Wright, Editor, Contract Pharma 03.11.21

Breaking News | Capsules | Industry News

CapsCanada Launches Liquid-Filled Hard Capsule Mfg. Service in North America

New service aims to return pharmaceutical and OTC drug manufacturing back to North America.

Kristin Brooks 03.10.21

Breaking News | Collaborations & Alliances | Drug Development

Selexis SA and BITT Enter Service Agreement

Will develop the cell line for BITR2101, BITT’s lead tumor necrosis factor receptor 2 oncology candidate.

Charles Sternberg, Assistant Editor 03.10.21

Breaking News | Collaborations & Alliances | Industry News

Cassava Sciences Enters Drug Supply Agreement with Evonik

Evonik will supply Cassava Sciences with large-scale, clinical-grade quantities of simufilam.

Charles Sternberg, Assistant Editor 03.09.21

Bio News | Breaking News | Industry News

NMPA Accepts Application for Clinical Trial of Bifunctional Fusion Protein

JS201, developed by Junshi Biosciences, can simultaneously target PD-1 and TGF-β.

Charles Sternberg, Assistant Editor 03.09.21

cGMP Manufacture | Process Development | Scale-up/Technology Transfer

Process Intensification: Understanding the Optimal Way to Maximize Productivity

Overcoming challenges of implementation and achieving increased volume, reduced timelines, decreased footprint, lower cost of goods, and increased flexibility.

Priyanka Gupta, Head of Market Entry Strategy for Protein Based Therapeutics, Sartorius 03.09.21

Bio News | Breaking News | Industry News

Cytovance Biologics Offers Licensing for Plasmid DNA Manufacturing

The Keystone Expression System pDNA platform is an end-to-end solution for manufacturing GMP pDNA at scale.

Tim Wright, Editor, Contract Pharma 03.09.21

Bio News | Biologics, Proteins, Vaccines | Facilities | Industry News

Arranta Bio Invests in New Manufacturing Facility

Addition of 130,000 sq. ft. Boxborough, MA, manufacturing facility to supply clinical and commercial microbiome products.

Tim Wright, Editor, Contract Pharma 03.09.21

Breaking News | Drug Delivery | Facilities | Industry News | Packaging & Tracking

Vectura Expands Dry Powder Inhaler Capabilities

Bolsters development and manufacturing capabilities at its facility in Chippenham, U.K.

Tim Wright, Editor, Contract Pharma 03.09.21

Breaking News | Industry News | Promotions & Moves

Sharp Appoints EU Qualified Person

Names Ria Rhemrev-Boom as its new lead EU Qualified Person (QP) for market release services.

Tim Wright, Editor, Contract Pharma 03.09.21

Promotions & Moves

Jubilant Therapeutics Appoints Chief Scientific Officer

Luca Rastelli brings more than 20 years of oncology drug discovery and development experience.

Kristin Brooks 03.08.21

Breaking News | Collaborations & Alliances

Iontas and Fair Journey Biologics Partner with Quell Therapeutics

Novel target binders from Iontas/FJB will be used to uncover functional antibodies to advance Quell’s engineered Treg cell therapy pipeline.

Charles Sternberg, Assistant Editor 03.08.21

Clinical Trials | Information Technology

Data Management Trends

Pandemic-fueled patient centricity is creating new challenges and opportunities for data management teams.

Deepu Joseph, Global Head & VP of Clinical Data Management 03.05.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

AGC Biologics Expands Cell and Gene Facility in Italy

Plans call for increased capacities and viral vector suspension capabilities at Milan site.

Tim Wright, Editor, Contract Pharma 03.05.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Celonic to Boost Cell & Gene Therapy Production

Will establish a new facility in the upcoming Life Science Park Rheintal in Stein, Switzerland.

Tim Wright, Editor, Contract Pharma 03.05.21

Emergent CDMO Capabilities - Perfecting Your Formula

For innovators taking on global health risks, rare diseases, or novel medicines, Emergent is an ideal integrated CDMO and a valued partner.

Breaking News

Fusion Pharmaceuticals Acquires IPN-1087

Expands its pipeline of potent alpha-emitting radiopharmaceuticals.

Charles Sternberg, Assistant Editor 03.02.21

Breaking News | Clinical Trials

Strata Oncology Unveils Strata PATH Trial

The new platform clinical trial will evaluate FDA-approved therapies in novel biomarker profiles learned from real-world data.

Charles Sternberg, Assistant Editor 03.02.21

Breaking News | Clinical Trials | CRO News | Information Technology

Alimentiv Acquires McDougall Scientific

Niche CRO specializes in statistical analysis, data management, reporting, and clinical trial design.

Kristin Brooks 03.02.21

Drug Delivery | Formulation Development

On Demand Webinar - Formulation Strategies for Poorly Soluble Molecules

Pharmaceutics and Biopharmaceutics Considerations - Now Available to Watch On Demand

Drug Delivery | Parenterals

Injectable Drug Delivery Trends

How medication trends are driving the shift to patient-friendly drug delivery systems.

Peter Soelkner, Managing Director, Vetter 03.01.21

Cold Chain Management | Logistics | Packaging & Tracking | Supply Chain

Reshaping the Pharmaceutical Supply Chain

The pandemic and COVID-19 vaccines bring navigating the cold-chain and preserving precious biologics to the forefront.

Kristin Brooks, Managing Editor 03.01.21

Breaking News | CRO News | Drug Discovery | Industry News | R&D

Icon to Acquire PRA Health Sciences

Brings together two organizations to create a leading healthcare intelligence and clinical CRO.

Charles Sternberg, Assistant Editor 03.01.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

BMS Expands Cell Therapy Manufacturing Capabilities

New state-of-the-art cell therapy manufacturing facility under construction to expand global footprint.

Tim Wright, Editor, Contract Pharma 03.01.21

Aseptic Processing | Breaking News | Industry News

Arcline Investment Acquires ChargePoint Technology

Acquisition of pharma equipment specialist will empower company to support global customers in responding to fast-changing markets.

Tim Wright, Editor, Contract Pharma 03.01.21

Breaking News | Promotions & Moves

Spark Therapeutics Appoints CTO

Cynthia Pussinen will oversee manufacturing and technical operations, including pipeline process development, preclinical and clinical manufacturing.

Kristin Brooks 02.26.21

Breaking News | Industry News

U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail

Purchase agreement is for $210 million and doses of bamlanivimab and etesevimab will be delivered through March 31, 2021.

Kristin Brooks 02.26.21

Solid Dosage/Creams/Ointments

Solid Dose Market Trends

A Q&A with Mark DaFonseca, chief business officer at CoreRx.

Tim Wright, Editor, Contract Pharma 02.26.21

Manufacturing Equipment Trends

Andreas Mattern of Syntegon Technology discusses latest technologies being leveraged in manufacturing equipment today.

Kristin Brooks 02.25.21

Bioanalytical Services | Breaking News | Industry News | Preclinical Outsourcing

Altasciences Contributes to Vibegron Approval

Provided clinical support for two drug-drug interaction studies and a bioavailability trial for the overactive bladder treatment.

Kristin Brooks 02.24.21

Breaking News | Drug Development | Industry News

Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement

Sentynl acquires CUTX-101 Copper Histidinate for the treatment of Menkes disease for $20 million in upfront and regulatory milestones.

Kristin Brooks 02.24.21

Analytical Services | Breaking News | Facilities | Industry News | Laboratory Testing

ACG Launches ACG Laboratories

Opens a process development lab in Shirwal, India.

Tim Wright, Editor, Contract Pharma 02.23.21

Breaking News | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments

Glatt and Aprecia Enter 3D-Printing Collaboration

Aprecia's compression-free 3DP manufacturing platform expands Glatt capabilities in innovative particle design.

Tim Wright, Editor, Contract Pharma 02.23.21

Breaking News | Collaborations & Alliances

NovalGen and Halix Enter Strategic Partnership

Halix will provide manufacturing of clinical supply of NovalGen’s therapies.

Charles Sternberg, Assistant Editor 02.22.21

Breaking News | Drug Development | Promotions & Moves

Aevitas Therapeutics Appoints President and CEO

Dr. Markus Peters offers a 25-year track record of developing and commercializing orphan and specialty pharmaceuticals.

Charles Sternberg, Assistant Editor 02.22.21

MaxiVAX, Minaris Enter Cell Therapy Mfg. Agreement

Minaris will provide GMP manufacturing, freezing and shipping of the MVX-ONCO-2 capsules from its site near Munich, Germany.

Kristin Brooks 02.22.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

G-CON Manufacturing Delivers & Installs PODs for Cell Therapy Manufacturing

Successfully completes the project within the client’s required schedule.

Charles Sternberg, Assistant Editor 02.19.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Intravacc Unveils New Pilot Vaccine Production Facility

State-of-the-art pilot plant for production of vaccine candidates in clinical phase I & II research.

Tim Wright, Editor, Contract Pharma 02.19.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Century Therapeutics Significantly Expands Capabilities

Unveils new operational, laboratory and manufacturing facilities in Pennsylvania and New Jersey.

Tim Wright, Editor, Contract Pharma 02.19.21

Breaking News | Collaborations & Alliances | Drug Development

Lilly, Rigel Enter Exclusive CNS Development Collaboration

Lilly will pay $125 million upfront and up to $835 million in potential milestones for Rigel's lead RIPK1 inhibitor, R552.

Kristin Brooks 02.18.21

Clinical Trial Start-Up: Effective Planning for Sponsors, CROs, and Sponsor-Investigators

...

02.17.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Novavax, SK Bioscience Expand Vax Pact

The existing partnership for manufacture of NVX-CoV2373 has been expanded to increase production capacity and supply vaccines to the Korean Government.

Charles Sternberg, Assistant Editor 02.17.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Charles River Acquires CDMO Cognate BioServices

Pays roughly $875 million to significantly expand capabilities in the cell and gene therapy sector.

Tim Wright, Editor, Contract Pharma 02.17.21

Virtual 2nd Conference on Neuroinflammation–Basic and Clinical Concepts

...

02.17.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Kaneka Eurogentec Expands Capabilities

Receives GMP accreditation for new mRNA manufacturing facility, COVID-19 vaccine production ongoing.

Tim Wright, Editor, Contract Pharma 02.17.21

Drug Delivery

Aerosol Delivery Devices Market

Advantages over conventional drug delivery devices, rise in prevalence of COPD and asthma drive the growth of the global aerosol delivery devices market.

Allied Market Research 02.16.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

Biomunex, Onward Ink Strategic Antibody Development Pact

Exclusive worldwide license and development agreement will leverage Biomunex' next gen bi- and multi-specific antibody platform in hematological malignancies.

Kristin Brooks 02.16.21

APIs | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site

Billingham site to support the manufacture of up to 180 million doses Novavax’ NVX-CoV2373 COVID-19 vaccine candidate.

Kristin Brooks 02.16.21

Lonza Expands Solid Small Molecule Services

To encompass all aspects of solid form screening and characterization of small molecule APIs.

Kristin Brooks 02.16.21

Breaking News | Facilities | Industry News

Scapa Healthcare Enhances OTC Drug Manufacturing Capabilities

Makes multimillion dollar investment at its Knoxville facility.

Tim Wright, Editor, Contract Pharma 02.10.21

Breaking News | Collaborations & Alliances | Industry News | Parenterals

LipoMedix, ForDoz Enter Manufacturing Agreement

Lead compound Promitil will be manufactured in the U.S. by ForDoz.

Tim Wright, Editor, Contract Pharma 02.10.21

AbbVie, Caribou Ink CAR-T Collaboration

Leverages Caribou's next-generation CRISPR genome editing technology platform and AbbVie's antigen-specific binders.

Tim Wright, Editor, Contract Pharma 02.10.21

Biologics, Proteins, Vaccines | Breaking News

RotaChrom Technologies Partners with Cyclolab

Aims to develop a more efficient and cost-effective process to purify Remdesivir, a widely used treatment option for COVID-19.

Charles Sternberg, Assistant Editor 02.09.21

Breaking News | Industry News

Lonza to Divest Specialty Ingredients Biz

Allows Lonza to focus on its position in the healthcare industry and to accelerate strategic priorities.

Kristin Brooks 02.09.21

Breaking News | Drug Development | Industry News | Laboratory Testing

Quotient Sciences Acquires Arcinova

Acquisition expands Quotient’s services with drug substance, drug product and clinical testing capabilities.

Kristin Brooks 02.09.21

Breaking News | Industry News | Promotions & Moves

AMRI Makes Executive Move

Appoints Scott Waldman to lead corporate development.

Tim Wright, Editor, Contract Pharma 02.08.21

Breaking News | Facilities | Industry News

Masy BioServices Expands Green Initiative

Completes a solar array project, installing 585 kW carports at its headquarters.

Charles Sternberg, Assistant Editor 02.08.21

Breaking News | CRO News | Industry News

Anova Enterprises Acquires Corlexia Clinical Services

Adds further depth and experience to the Anova leadership team.

Charles Sternberg, Assistant Editor 02.08.21

Thermo Fisher, JW Therapeutics Form CAR-T Partnership in China

Companies join forces in cell therapy applications and commercial-scale manufacturing.

Tim Wright, Editor, Contract Pharma 02.08.21

Argonaut Opens Custom Controls and Standards Facility

Formulation and filling will be performed at a state-of-the-art site in Carlsbad, CA.

Tim Wright, Editor, Contract Pharma 02.08.21

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Vigene Plans Major Expansion in Maryland

Global gene therapy and vaccine manufacturing company taking additional space in Rockville and adding up to 245 jobs.

Tim Wright, Editor, Contract Pharma 02.08.21

Aseptic Processing | Breaking News | Industry News

Cytiva Acquires Canadian Aseptic Filling Innovator

Deal for Vanrx Pharmasystems supports global trends towards smaller manufacturing and the advent of personalized therapies.

Tim Wright, Editor, Contract Pharma 02.08.21

Breaking News | Industry News

TCG Lifesciences Expands Footprint to the U.S.

Establishes CDMO subsidiary TCG GreenChem in New Jersey and Virginia.

Tim Wright, Editor, Contract Pharma 02.08.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Paragon Biosciences Expands Cell and Gene Therapy Platform

Launches CiRC Biosciences with an initial focus on developing eye disease treatments.

Tim Wright, Editor, Contract Pharma 02.08.21

Catalent, Trizell Enter Cell Therapy Deal

Sign development and manufacturing agreement with for macrophage-based advanced cell therapy.

Tim Wright, Editor, Contract Pharma 02.08.21

Biologics, Proteins, Vaccines | Clinical Trials

Inside a COVID Vaccine Trial

Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.

Kristin Brooks, Managing Editor 02.05.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

CureVac, UK Partner on Vaccines Against SARS-CoV-2 Variants

Aims to mitigate the effects of the pandemic and help prepare against future SARS-CoV-2 outbreaks by working on multiple variant vaccines.

Kristin Brooks 02.05.21

Industry News

Sepha Launches Small Batch Contract Packaging Service

Aims to provide cost-effective, low volume runs of blister and medical device packs within short turnarounds.

Kristin Brooks 02.05.21

Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development

The Future of Vaccines and Biologics

Dr. Linda Marbán of Capricor Therapeutics discusses the advances in responding to infectious diseases.

Kristin Brooks, Managing Editor, Contract Pharma 02.04.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings

Vaxart Oral COVID-19 Vax Tablet Shows Promise

Phase I study reached primary and secondary endpoints of safety and immunogenicity.

Kristin Brooks 02.03.21

Breaking News | Clinical Trials | Drug Development | Industry News

Affimed, Roche Explore AFM24, Tecentriq Combo

To investigate the combination for the treatment of advanced solid epidermal growth factor receptor (EGFR) expressing malignancies.

Kristin Brooks 02.03.21

Breaking News | Collaborations & Alliances | Drug Development

Imcyse, Pfizer Enter Autoimmune Research Alliance

Will develop Imotope candidates to potentially treat Rheumatoid Arthritis.

Charles Sternberg, Assistant Editor 02.03.21

Immunome, Abzena Enter COVID-19 Antibody Cocktail Agreement

Abzena will work with Immunome to produce the antibody cocktail for clinical testing.

Kristin Brooks 02.03.21

Breaking News | Clinical Trials | Drug Development | Industry News

DoD Awards Rigel $16.5M to Support Fostamatinib COVID Trials

Will evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure.

Kristin Brooks 02.01.21

Breaking News | Fill/Finish | Industry News

Cytiva Acquires Vanrx Pharmasystems

Canadian innovator makes robotic aseptic filling machines to fill vials, syringes, and cartridges with reduced risk.

Kristin Brooks 02.01.21

Biologics, Proteins, Vaccines | Breaking News

UK Secures 40M Doses of Valneva COVID-19 Vax

Brings the total volume of the Valneva vaccine ordered by UK Government to 100 million doses.

Charles Sternberg, Assistant Editor 02.01.21

Breaking News | Drug Development | Industry News

Lilly Acquires Asahi Kasei’s Chronic Pain Candidate

To pay $20 million upfront and up to $210 million in potential milestones for AK1780, an orally bioavailable P2X7 receptor antagonist.

Kristin Brooks 02.01.21

Breaking News | Drug Development | Industry News

Gilead, Gritstone Enter Vax Platform Pact for HIV Cure

Aims to develop HIV-specific vaccine using Gritstone’s prime-boost vaccine platform with antigens developed by Gilead.

Kristin Brooks 02.01.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

CureVac, Rentschler Ramp up COVID Vax Production

Rentschler responsible for manufacturing, downstream processing and formulation of CureVac’s CVnCoV in Laupheim, Germany.

Kristin Brooks 02.01.21

Cognate BioServices, Nucleus Biologics Form Cell & Gene Therapy Partnership

Will focus on clinical and commercial clients, especially as Cognate expands its business with allogeneic and autologous on-demand cell and gene therapies.

Tim Wright, Editor, Contract Pharma 01.29.21

Cold Chain Management | Logistics | Supply Chain

Delivering Custom Client Solutions

Cold chain solutions provider Sentry BioPharma Services is able to adapt to meet the diverse needs of its clients.

Contract Pharma Staff

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Lonza Launches Cryopreserved Leukopaks

Customizable cryopreserved Leukopaks aim to provide greater flexibility in immunology and cell therapy research.

Kristin Brooks 01.28.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Valneva Begins COVID Vax Production to Optimize Potential Deliveries

Inactivated, adjuvanted COVID-19 vaccine candidate is in Phase 1/2 clinical development with initial results in April 2021.

Kristin Brooks 01.28.21

Parenterals

Parenteral Drug Delivery Trends

A Q&A with Lubrizol Life Science Health’s CDMO Division President, Rob Lee.

Kristin Brooks, Managing Editor, Contract Pharma 01.27.21

COVID-19 Impact Report

Leaders across the pharmaceutical contract services industry reflect on the impact of COVID-19 in 2020, and what to expect in 2021.

Tim Wright, Editor, Contract Pharma 01.27.21

Ajinomoto Bio-Pharma, Humanigen Expand Manufacturing Agreement

Ajinomoto will support fill finish for investigational COVID-19 therapeutic, lenzilumab, nearing completion of phase 3 study.

Tim Wright, Editor, Contract Pharma 01.27.21

Almac Expands Global Biologics Testing Services

Investment in mass spectrometry support aims to accelerate biologics development and approval.

Tim Wright, Editor, Contract Pharma 01.27.21

GRAM Makes Major Investment in Additional Advanced Equipment

Bausch+Ströbel vial filler with SKAN Isolator technology, and VarioSys syringe and vial filler set to arrive in early 2022.

Tim Wright, Editor, Contract Pharma 01.27.21

Clinical Trials | Information Technology

The State of Clinical Trial Technology

Blake Adams of Florence discusses key report findings and the clinical trial software used to support Pfizer’s global COVID-19 vaccine study.

Kristin Brooks, Contract Pharma 01.26.21

Breaking News | Formulation Development | Industry News | Methods Development

Adare Pharma Solutions Opens New Small-Scale Lab

Vandalia, OH lab offers customizable, flexible systems designed to expedite formulation and process development services.

Kristin Brooks 01.26.21

Clinical Trials

The Future of Clinical Trials Series: Part II

Greater awareness will ensure diversity is no longer an afterthought and patients will be at the center of every aspect of clinical research.

Jena Daniels, Rasmus Hogreffe, Ingrid Oakley-Girvan, Dr. Michelle Longmire, Medable 01.26.21

Breaking News | Industry News

Stevanato Group Launches After-sales Service Offering

Aims to deliver a more customized experience for optimal machine maintenance, performance and utilization.

Kristin Brooks 01.26.21

Aphena’s $21M Cookeville Expansion Nears Completion

Bottle packaging capacity has been expanded with the installation of 10 high-speed bottling lines to start.

Kristin Brooks 01.26.21

Breaking News | Clinical Trials | Industry News

Care Access Research, AstraZeneca Partner on COVID-19 Antibody Trial

Care Access to provide decentralized, mobile research site operations for AstraZeneca’s AZD7442 Phase III trial in the U.S.

Kristin Brooks 01.26.21

Breaking News

500+ Sites Join Inato’s Industry Marketplace

Platform aims to make clinical research more inclusive and efficient.

Charles Sternberg, Assistant Editor 01.26.21

Breaking News | Clinical Trials | Drug Development | Industry News | Laboratory Testing

Caprion-HistoGeneX Rebrands as CellCarta

Recently expanded its scientific capabilities and geographic presence with the acquisitions of Clinical Logistics Inc. and Mosaic Laboratories.

Kristin Brooks 01.26.21

Humanigen, Emergent Enter Covid-19 Partnership

Sign contract development and manufacturing agreement for Phase 3 COVID-19 therapeutic candidate lenzilumab.

Tim Wright, Editor, Contract Pharma 01.25.21

Breaking News | Drug Development | Drug Discovery | Industry News

Lilly Completes $1B Acquisition of Prevail

Adds new modality for drug discovery and development and creates a gene therapy program with neuroscience assets.

Kristin Brooks 01.22.21

Analytical Services | Laboratory Testing

Improving Product Profitability

Using PAT/QbD/CM as tools to increase profitability of products.

Emil Ciurczak, Contributing Editor 01.21.21

Breaking News | Promotions & Moves

Eisai Appoints Chief Clinical Officer of Oncology Biz

Dr. Richard Woodman has 18 years of pharmaceutical experience in several different functional areas at both large and small biotech organizations.

Contract Pharma Staff 01.20.21

Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Industry News

Nexelis Acquires GSK Vax Lab in Marburg

Enters into a 5-year strategic agreement to support the development of future GSK vaccine candidates.

Contract Pharma Staff 01.20.21

Clinical Trials

The Future of Clinical Trials Series: Part I

What will 2021 have in store for an industry in flux?

Alison Holland, Head of Decentralized Trials, Medable, Maria Fotiu, Executive Vice President of Decentralized Solutions, Syneos Health 01.19.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

Bone Therapeutics, Rigenerand Ink Cell Therapy Deal

Enter an agreement for a process development partnership.

Contract Pharma Staff 01.19.21

Breaking News | Industry News

NovaQuest Private Equity Acquires CoreRx

New strategic financial sponsor to support continued growth and capability expansion.

Contract Pharma Staff 01.19.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

JS Bio and Etta Biotech Advancing Partnership

Will set up a high titer transient protein expression platform for high quality protein production.

Contract Pharma Staff 01.19.21

Intravacc Completes Project for Provention Bio’s Vax Candidate

Potentially the first preventive vaccine for coxsackievirus B, a risk factor associated with type 1 diabetes and celiac disease.

Contract Pharma Staff 01.19.21

Breaking News | Clinical Trials | Industry News

Grifols Begins COVID-19 Plasma Treatment Trial

Treatment could be used for people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease, complementing the vaccine.

Contract Pharma Staff 01.18.21

Breaking News | Industry News

KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio

New lineup aims to address challenges from early stage powder characterization and formulation development to scale-up and production.

Contract Pharma Staff 01.15.21

Clinical Trials | Drug Development | Information Technology

Virtual Clinical Trials: The Future of Dermatology Studies

COVID-19 has created lasting impacts for clinical trials and a host of benefits have arisen from the adoption of virtual and hybrid models.

Sonja VanWye, RN, MSN, Director, Dermatology Strategy, IQVIA Biotech 01.15.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Cognate BioServices Announces Major Expansion

Will increase cell and gene therapy manufacturing capacity, laboratory space, warehousing capabilities and more.

Contract Pharma Staff 01.15.21

Breaking News | Collaborations & Alliances | CRO News | Industry News

Bioclinica Partners with Ikcon Pharma

Will work together to deliver best-in-class e-clinical solutions to the pharma industry & sponsors.

Contract Pharma Staff 01.15.21

Breaking News | Clinical Trials | CRO News | Industry News

Frontage Bolsters Clinical Services Capabilities

Unveils plans to provide full service human radiolabeled absorption, metabolism, and excretion study capabilities.

Contract Pharma Staff 01.15.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz

Pays more than $800 million to expand global capacity and address growing demand for cell and gene therapy.

Contract Pharma Staff 01.15.21

Your Pre-clinical Toxicology Program Needs a Strategy

At Syngene, we have developed a roadmap across pre-IND, IND and NDA that seamlessly integrate the various pre-clinical studies.

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Cytiva Delivers Modular Biologics Factory to Lonza

Site to become a strategic base in China for Lonza to provide CDMO services throughout Asia Pacific region.

Contract Pharma Staff 01.14.21

APIs | Breaking News | cGMP Manufacture | Fill/Finish | Industry News

LSNE Expands Fill Finish and Lyophilization Ops

New automated fill line at Bedford Campus adds ready-to-use aseptic filling and freeze-dryer capacity.

Contract Pharma Staff 01.14.21

Clinical Development

Syngene supports early-phase to late-phase clinical trials required for drug development programs across a wide range of therapeutic areas.

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

RheinCell Therapeutics Achieves GMP Certification

Marks a milestone for the evolution of the company.

Contract Pharma Staff 01.13.21

Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News

EVOQ Therapeutics and Amgen Partner

Collaborate on the discovery and development of novel drugs for autoimmune disorders.

Contract Pharma Staff 01.13.21

Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

The CDMO pays $80 million for dry powder inhaler spray drying, capsule manufacturing and packaging operations in Boston area.

Contract Pharma Staff 01.13.21

Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Industry News | Process Development

Capricor, Lonza Enter CAP-1002 Development Agreement

Lonza will perform process development activities for late-clinical and commercial-scale GMP manufacturing of CAP-1002.

Contract Pharma Staff 01.12.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

Adagene Achieves CAR-T Collaboration Milestone

Yields potential first-ever antibodies targeting human endogenous retrovirus associated with kidney cancer.

Contract Pharma Staff 01.12.21

Breaking News | Formulation Development | Industry News

Hovione Launches ASD-HIPROS

Advanced tool designed to identify optimal and commercially viable Amorphous Solid Dispersions formulation by Spray Drying.

Contract Pharma Staff 01.12.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News | Parenterals

Irisys Receives NIH Contract for the Formulation of Drinabant

Seeks to develop a drug for treatment of acute cannabinoid overdose.

Contract Pharma Staff 01.11.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Fujifilm Diosynth Biotechnologies Begins COVID-19 Vax Production

Texas A&M System contract designates the CDMO’s Texas facility for emergency federal use.

Contract Pharma Staff 01.11.21

The Alcami Advantage

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Clinical Trials | CRO News

Caprion-HistoGeneX Acquires Clinical Logistics

Expands its support of clinical trials specimen logistics.

Contract Pharma Staff 01.08.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News | Laboratory Testing

Biohaven Acquires Remaining Stake in Kleo Pharmaceuticals

Enters exclusive license agreement with Yale University for a novel extracellular degrader technology licensed from Spiegel Lab.

Contract Pharma Staff 01.08.21

Promotions & Moves

Ionis Appoints Clinical Development EVP

Eugene Schneider will oversee clinical development of novel antisense medicines across all of Ionis' therapeutic franchises.

Contract Pharma Staff 01.08.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Biogen Licenses CEVEC AAV Mfg. Technology

Biogen gains rights to ELEVECTA Technology for manufacturing of gene therapy products.

Contract Pharma Staff 01.08.21

Aseptic Processing | Breaking News | Collaborations & Alliances | Parenterals

Catalent Divests Blow-Fill-Seal Sterile CDMO Business

SK Capital makes the acquisition; new independent company to be formed.

Contract Pharma Staff 01.07.21

APIs | Breaking News | cGMP Manufacture | Facilities | Industry News

AmbioPharm Opens New Shanghai Campus

Adds European executive team members working out of new Zurich office.

Contract Pharma Staff 01.07.21

Clinical Trials | Drug Development

The Slow – But Desperately Needed – Evolution of Oncology Clinical Development Designs

Appropriate adaptive designs in early stages of development can accelerate timelines and reduce costs, and help focus on the most promising agents.

Jürgen Hummel, MSc, Senior Director, Statistical Science, PPD, and Lead of PPD’s Adaptive Design Working Group 01.07.21

Alcami Expands Oral Solid Capabilities with Investment in Wilmington, NC

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Oligonucleotides

Syngene's services encompass Therapeutic oligonucleotides, Diagnostic Oligonucleotides, Enzymatic synthesis and analytical services.

Clinical & Translational Biomarkers

...

01.06.21

Breaking News

Bioclinica Acquires Saliency

Integrates the company's advanced AI technology into its Imaging Platform.

Contract Pharma Staff 01.06.21

Structural Characterization of Biologics Using High-Resolution Mass Spectrometry

High-resolution mass spectrometry is a key component in the characterization of novel biologics and biosimilars.

Breaking News | Clinical Trials | Promotions & Moves

Parexel Appoints Chief Patient Officer

Demonstrates the company’s commitment to elevating the patient perspective.

Contract Pharma Staff 01.06.21

The Importance of Food Studies in Pharmaceutical Development

Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients.

Genezen Laboratories Receives Growth Equity Investment

Will fund the completion of the company’s lentiviral vector production facility.

Contract Pharma Staff 01.05.21

Breaking News | Collaborations & Alliances | Industry News

Angelini Pharma Acquires Arvelle Therapeutics for $960M

Angelini to become a leader in CNS and mental health disorder treatments; opening direct affiliates in France, UK, Nordics and Switzerland by 2022.

Contract Pharma Staff 01.05.21

Akston Biosciences and LakePharma Enter Covid-19 Partnership

Will manufacture second-generation COVID-19 vaccine, AKS-452.

Contract Pharma Staff 01.05.21

Fujifilm to Invest $40M in New Facility

State-of-the-art viral vector and advanced therapy process development and manufacturing facility will be located in Boston area.

Contract Pharma Staff 01.05.21

Drug Development | Industry News | Regulatory Affairs

The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".

Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21

Breaking News | CRO News | Drug Discovery | Preclinical Outsourcing

Charles River Labs Acquires Distributed Bio

Establishes integrated, large molecule discovery platform.

Contract Pharma Staff 01.04.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

AGC Biologics Manufactures Orchard Therapeutics' Libmeldy

European Commission approves one-time therapy for early-onset Metachromatic Leukodystrophy, manufactured at AGC's Milan facility.

Contract Pharma Staff 01.04.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

INOVIO, Advaccine Enter Exclusive COVID-19 DNA Vax Pact

Partnership adds Asian manufacturing resource to INOVIO's global manufacturing consortium for INO-4800.

Contract Pharma Staff 01.04.21

Lonza Expands Conjugation Facility in Visp

Two additional manufacturing suites will provide development and manufacturing capacity for preclinical to commercial supply.

Contract Pharma Staff 12.21.20

Breaking News | Industry News | Trials & Filings

Moderna Wins FDA Authorization for COVID-19 Vax

The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.

Contract Pharma Staff 12.21.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

BioNTech, Shanghai Fosun Pharma to Supply COVID-19 Vax to China

Sign an agreement to provide 100 million doses of their BNT162 mRNA-based vaccine candidate in 2021.

Contract Pharma Staff 12.18.20

Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Thermo Fisher Expands Plasmid DNA Mfg. Capabilities

New 67,000-square-foot Carlsbad, CA cGMP site will accelerate commercialization of plasmid-based medicines and vaccines.

Contract Pharma Staff 12.17.20

Bioanalytical Services | Breaking News | cGMP Manufacture | Industry News

Passage Bio Invests in Gene Therapy Manufacturing R&D Site

In combination with dedicated cGMP suite at Catalent, the new lab creates foundation for integrated AAV gene therapy manufacturing.

Contract Pharma Staff 12.17.20

APIs | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News

Aurinia and Lonza Expand Manufacturing Partnership

Form agreement for voclosporin manufacturing capacity.

Contract Pharma Staff 12.16.20

CDMO Cognate BioServices Teams Up with L7 Informatics

To implement L7|ESP for integrated manufacturing and lab operations.

Contract Pharma Staff 12.16.20

CHA Biotech Launches Global CDMO Biz

Matica Biotechnology to construct GMP facility for viral vector production in Texas.

Contract Pharma Staff 12.16.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

INOVIO to Develop dMAb COVID Treatments under DARPA Grant

$37.6 million grant will leverage AstraZeneca's monoclonal antibody and INOVIO's dMAb technologies in the fight against COVID-19.

Contract Pharma Staff 12.15.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Lilly to Acquire Prevail Therapeutics in $1B Deal

Adds a new drug discovery and development modality and creates a gene therapy program anchored by Prevail's portfolio of neuroscience assets.

Contract Pharma Staff 12.15.20

Got Floor Space? – Increase Workspace Efficiency

By JULIE MENO, Strategic Initiatives Manager, FEDERAL EQUIPMENT COMPANY

Breaking News | Industry News

AstraZeneca to Acquire Alexion in $39B Deal

Expands scientific presence in immunology by adding Alexion's innovative complement-technology platforms and strong pipeline, and top seller Soliris.

Contract Pharma Staff 12.14.20

Clinical Trials | Drug Development | Information Technology

Advancing Digital Endpoints in Clinical Trials

An end-to-end approach to managing wearable devices through clinical development.

Kristin Brooks, Contract Pharma 12.14.20

Breaking News | Industry News

CPI Scales Up Manufacturing of Pyocin S5

A promising treatment for lung infection in cystic fibrosis patients developed by the University of Glasgow.

Contract Pharma Staff 12.14.20

Clinical Trials | Information Technology

Life Sciences Strive for Greater Agility

Embracing real-time drug safety monitoring during and post COVID will continue to propel the industry forward.

Ronan Brown, SVP of Integrated Technology & Compliance, and Joe Rymsza, VP, Global PV & Regulatory Technology Solutions, IQVIA 12.14.20

Breaking News | Cytotoxics and High Potency Manufacturing | Drug Delivery | Facilities | Industry News

Inhalation CDMO Vectura Expands HPAPI Capabilities

New facility will increase containment operations at Chippenham, UK site.

Contract Pharma Staff 12.14.20

Drug Development

Navigating Uncertainty: Considerations for Life Sciences 2021

With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.

Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP 12.11.20

Breaking News | cGMP Manufacture | Drug Development | Industry News | R&D

Ascentage Selects PharmaBlock as Preferred Provider

PharmaBlock will support Ascentage in accelerating its drug development pipeline with R&D, manufacturing capacity, and technological solutions.

Contract Pharma Staff 12.11.20

Breaking News | cGMP Manufacture | Industry News

Passage Bio, Catalent Begin cGMP Mfg. for Gene Therapies

Completion of dedicated cGMP suite enhances manufacturing readiness and secures supply chain control to support lead CNS product candidates.

Contract Pharma Staff 12.10.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Orgenesis, Cure Therapeutics Form JV

Aims to advance point-of-care development and commercialization of cell and gene therapies.

Contract Pharma Staff 12.10.20

Breaking News | Drug Development | Promotions & Moves

Catalent Appoints Minakuchi Facility GM

Nakaya “Nick” Matsumaru joins the company from SymBio Pharmaceuticals.

Contract Pharma Staff 12.10.20

Biologics, Proteins, Vaccines | Breaking News | Industry News

Boehringer to Acquire NBE-Therapeutics in €1.2B Transaction

Gains iADC platform and potential best-in-class antibody-drug conjugate (ADC) therapies for the treatment of solid tumors.

Contract Pharma Staff 12.10.20

Breaking News | Industry News | Trials & Filings

Health Canada Authorizes Pfizer, BioNTech COVID-19 Vax

Pfizer Canada and BioNTech will supply the Government of Canada a minimum of 20 million doses and up to 76 million doses of the vaccine through 2021.

Contract Pharma Staff 12.10.20

Logistics4Pharma Facility Passes Inspection

German logistics firm completes validation of GDP cold chain storage and transportation at Frankfurt facility.

Contract Pharma Staff 12.09.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Health Canada Green Lights COVID-19 Vax

Canadian regulator authorizes supply and emergency use of Pfizer and BioNTech’s COVID-19 mRNA vaccine.

Contract Pharma Staff 12.09.20

APIs | Breaking News | Clinical Trial Materials | Facilities | Industry News

Recipharm Expands API Manufacturing Capabilities

Invests $2.5 million in clinical GMP capacity for APIs at Israel facility.

Contract Pharma Staff 12.09.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

atbtherapeutics, iBio CDMO Enter Manufacturing Agreement

Will work together for the industrialization of the GMP manufacturing process of atbtherapeutics’ atbodies.

Contract Pharma Staff 12.09.20

Sesen Bio Enters Mfg. and Supply Partnership with Qilu Pharma

Technology transfer to Qilu anticipated to be completed in mid-2021.

Contract Pharma Staff 12.09.20

Breaking News | CRO News | Industry News | R&D

LINK Medical Acquires IRW Consulting AB

Strengthens its position in the Nordics while improving its offerings and capabilities.

Contract Pharma Staff 12.09.20

Breaking News | Promotions & Moves

Natoli Engineering Appoints West Coast Service Tech

Gerardo Zuniga brings 20 plus years of experience leveraging problem-solving techniques to implement corrective and preventative actions.

Contract Pharma Staff 12.08.20

APIs | Breaking News | cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News

Piramal Invests $32M to Expand Michigan Facility

Includes additional capacity in Potent and Non-Potent API development and manufacturing.

Contract Pharma Staff 12.08.20

Breaking News | cGMP Manufacture | Industry News | QA/QC | Validation

UK’s VMIC to Implement Lonza’s MODA-EM

To digitize its Microbiology Quality Control operations.

Contract Pharma Staff 12.08.20

Breaking News | cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News

Catalent Invests $10M in Isolator Capabilities to Expand Micronization

Will allow flexible jet milling ops to be carried out at sites in Malvern, PA and Dartford, U.K. under high containment.

Contract Pharma Staff 12.04.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Keneka Eurogentec Joins Inovio’s Global Mfg. Consortium

Agrees to manufacture Innovio’s Covid-19 vaccine candidate INO-4800.

Contract Pharma Staff 12.03.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Tubulis, WuXi Biologics and WuXi STA Form Strategic Pact

Will advance a new generation of antibody-drug conjugates towards clinical evaluation.

Contract Pharma Staff 12.03.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Batavia Biosciences and KU Leuven Join Forces

Will accelerate the development of a highly promising Covid-19 vaccine candidate.

Contract Pharma Staff 12.03.20

Breaking News | Drug Development

ViGeneron and WuXi Advanced Therapies Enter Partnership

Will accelerate production for the clinical development of VG901, a next-generation ophthalmic gene therapy program.

Contract Pharma Staff 12.02.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Lonza Enters Long-term Bioconjugation Collaboration

Will construct two new customer-dedicated conjugation suites for the commercialization of antibody-drug conjugates at its Visp site.

Contract Pharma Staff 12.02.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Trials & Filings

Pfizer, BioNTech Win First Authorization for COVID-19 Vax

MHRA authorizes supply of BNT162b2 vaccine for emergency supply; companies are ready to deliver the first doses to the U.K. immediately.

Contract Pharma Staff 12.02.20

Breaking News | Drug Development | Promotions & Moves

NeuBase Therapeutics Appoints Chief Scientific Officer

Dr. Curt Bradshaw brings decades of experience in successfully delivering genetic medicines to clinics.

Contract Pharma Staff 12.02.20

Bioanalytical Services | Breaking News | cGMP Manufacture | Industry News

KBI Biopharma Expands U.S. Ops

Invests $150 million in commercial biologics manufacturing facility in RTP, NC.

Contract Pharma Staff 12.02.20

Pfizer, BioNTech Submit CMA for Covid-19 Vax to EMA

Approval could potentially enable the use of BNT162b2 in Europe before the end of 2020.

Contract Pharma Staff 12.01.20

CDMO Stelis Continues Expansion

Starts next phase of investment into its biologics manufacturing facility.

Contract Pharma Staff 12.01.20

Breaking News | Clinical Trials | Industry News

SGS Initiates U.S. COVID-19 Clinical Trials

Phase 2/3 trial will examine the safety, tolerability, and efficacy of Sarconeos (BIO101) to treat COVID-19 related respiratory failure.

Contract Pharma Staff 11.30.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Formulation Development | Industry News

Lonza Expands Development, Mfg. Capabilities at Bend Site

Investment will add 11 new suites for particle engineering and drug product capacity to improve program lead times.

Contract Pharma Staff 11.30.20

Life Science Success Podcast: Matt Hicks

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APIs | Breaking News | Facilities | Industry News

CordenPharma Colorado Increases US Peptide Manufacturing Capacity

Long-term expansion initiative approved to further increase flexibility, efficiency and ultimately, cost-effective production.

Contract Pharma Staff 11.25.20

CureVac and Wacker Sign Contract for Manufacturing of Covid-19 Vaccine Candidate

Manufacturing at Wacker’s biotech site in Amsterdam is scheduled to start in the first half of 2021.

Contract Pharma Staff 11.24.20

Bio News | Breaking News | Collaborations & Alliances | Industry News | Supply Chain

Lonza and Be The Match BioTherapies Enter CGT Partnership

Will expand Vein-to-Vein Cell and Gene Therapy Supply Chain Network.

Contract Pharma Staff 11.24.20

Bio News | Breaking News | Facilities | Industry News

Samsung Biologics Breaks Ground on 'Super Plant'

When completed, the CDMO says it will be the world's largest bio-manufacturing facility.

Contract Pharma Staff 11.24.20

Drug Delivery | Drug Development

Inhaled Drug Delivery Technology Trends

The success of new inhaled medicines relies on the correct combination of formulation and device technology.

Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura 11.24.20

Breaking News | Clinical Trials | Industry News

Merck Acquires OncoImmune for $425M

Acquisition adds to Merck’s suite of clinical programs in response to SARS-CoV-2/COVID-19.

Contract Pharma Staff 11.24.20

Baxter Invests $50M to Expand Sterile Fill/Finish Manufacturing Operations

Construction currently underway; expected to be completed in 2021.

Contract Pharma Staff 11.24.20

Breaking News | Drug Development | Trials & Filings

Regeneron's COVID-19 Antibody Cocktail Gets EUA

Expects to have treatment doses ready for approximately 80,000 patients by the end of November, and 200,000 by the first week of January.

Contract Pharma Staff 11.23.20

Breaking News | Promotions & Moves

Summit Therapeutics Appoints Chief Operating Officer

Dr. Mahkam Zanganeh previously founded and led Maky Zanganeh and Associates consulting services firm.

Contract Pharma Staff 11.23.20

Breaking News | Collaborations & Alliances | Drug Development

Amgen Ends Cardio Alliance with Cytokinetics

Will transition the development and commercialization rights for omecamtiv mecarbil to Cytokinetics and Servier.

Contract Pharma Staff 11.23.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

ARCA Biopharma’s AB201 for COVID-19 Gets Fast Track

Initiation of ASPEN-COVID-19 Phase 2b clinical trial anticipated in December with trial data anticipated 2Q21.

Contract Pharma Staff 11.23.20

Breaking News | Industry News | Promotions & Moves

Frontida BioPharma Appoints EVP Technology

Dr. Praful Agrawala brings years of pharmaceutical product development leadership experience to the company.

Contract Pharma Staff 11.20.20

August Bioservices Expands Operations in Nashville

Plans to invest $64.7 million and create 180 jobs over the next five years.

Contract Pharma Staff 11.20.20

Pfizer and BioNTech to Submit EUA for COVID-19 Vaccine

Expect to produce globally up to 50 million doses in 2020, up to 1.3 billion doses by the end of 2021; ready to distribute within hours after authorization.

Contract Pharma Staff 11.20.20

Promotions & Moves

Catalent Appoints Open Innovation, Biologics, Cell and Gene Therapy VP

Behzad Mahdavi brings more than 20 years of experience in developing and implementing growth strategies in the biopharmaceutical industries.

Contract Pharma Staff 11.19.20

Collaborations & Alliances | Drug Development

Cue Biopharma, Merck Extend Biologics Research Alliance

To develop clinical candidate for the treatment of type 1 diabetes and an additional undisclosed autoimmune disease.

Contract Pharma Staff 11.19.20

Biologics, Proteins, Vaccines | Industry News

Avantor Opens New Biorepository Facility in Europe

Supports growing demand for scientific research and clinical trial sample storage.

Contract Pharma Staff 11.19.20

Breaking News | CRO News | Facilities | Industry News

SGS Plans to Move Its Clinical Pharmacology Unit

Increases its capacity to conduct Human Challenge studies.

Contract Pharma Staff 11.18.20

cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News

Lonza Expands HPAPI Capabilities

Invests more than $15 million to expand and upgrade the Tampa, FL site.

Contract Pharma Staff 11.18.20

Breaking News | Facilities | Industry News

CordenPharma Expands Peptide Development Capacity

Increases CoE for peptide development capacity to support European domestic growth.

Contract Pharma Staff 11.18.20

Breaking News | Facilities | Industry News

Comar Breaks Ground in Vineland, NJ

New 159,000 square-foot site will house injection molding machines, proprietary automation, and packaging equipment.

Contract Pharma Staff 11.18.20

Breaking News | Industry News | Information Technology | Promotions & Moves

Sharp Implements Cloud-Based QMS

Strengthens quality leadership with new appointments.

Contract Pharma Staff 11.18.20

Bio News | Breaking News | Industry News

Bionova Scientific Secures First Client Commitment

Its new biologics manufacturing facility is still months from completion.

Contract Pharma Staff 11.18.20

APIs | Breaking News | Industry News

Almac Gets Grant From COVID-19 Therapeutics Accelerator

Will work to enable efficient manufacturing of remdesivir in Response to COVID-19.

Contract Pharma Staff 11.18.20

Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments

Syntegon Opens New OSD Customer Center

Six times more cleanroom capacity for customer projects in Waiblingen, Germany.

Contract Pharma Staff 11.18.20

Cell & Gene Therapy Supply Chain: Early Preparation is Key

Supply chain management for cell and gene therapies requires precise demand planning and forecasting.

Matthew Farabaugh, Chief Financial Officer, The Discovery Labs 11.17.20

A Potential “Marriage”

Initiator companies and generics/CMOs working together.

Emil W. Ciurczak, DoraMaxx Consulting 11.17.20

Injectables Firms Expand Capacity

CDMOs see steriles demand grow.

S. Harachand, Contributing Editor 11.17.20

Clinical Trials | Information Technology | R&D

Decentralized Trials Fuel AI Revolution in Clinical Research

The life sciences industry is giving clinical a full makeover, dramatically improving how new therapeutics are developed.

Nick Moss, Vice President of Analytics and Machine Learning, Medable 11.17.20

Biologics, Proteins, Vaccines | Inspections | Supply Chain

Inspecting the Unexpected

Preparing quality control processes for COVID-19 vaccine candidates.

Dr. Andrea Sardella and Raffaele Pace, Stevanato Group 11.17.20

Scale-up/Technology Transfer

Ensuring Quality During the Transfer and Scale Up of Rx Drugs

Defining the key parameters and considerations for a successful technology transfer.

Tom Chang, President, Bora Pharmaceutical Laboratory Co. Ltd. 11.17.20

Breaking News

Syneos Health Appoints Chief Information & Digital Officer

Larry A. Pickett brings 30 years of relevant experience.

Contract Pharma Staff 11.17.20

Bioassay Development | Biologics, Proteins, Vaccines | Drug Development | Facilities

Opportunities in Synthetic Biology

Les Tillack, CEO of Luina Bio, discusses how ‘synbio’ is driving growth in the biopharma industry.

Contract Pharma Staff

Collaborations & Alliances | Drug Development

XOMA Earns $2M Takeda Milestone

Mezagitamab advances into Phase 2 development in generalized myasthenia gravis.

Contract Pharma Staff 11.17.20

Capsules | Solid Dosage/Creams/Ointments | Solid Dosage/Semi-solids

Double-blinding and removing bias with over-encapsulation

While there are many blinding options available, over-encapsulation remains the most popular method adopted by sponsors to meet regulatory demands.

G2GBio Deploys Micropore’s Membrane Technology

Plans to manufacture sustained release pharmaceutical products.

Contract Pharma Staff 11.16.20

Breaking News | Industry News | Promotions & Moves

Pii Appoints Business Development Director

Brian Sasaki brings 20 years of experience to the role.

Contract Pharma Staff 11.16.20

Breaking News | Collaborations & Alliances | Industry News

Lead Pharma and Roche Enter Collaboration & License Agreement

Will develop oral small molecules to treat immune mediated diseases.

Contract Pharma Staff 11.16.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Vibalogics Establishes U.S. Presence

Will open virotherapy facility in Boston and plans to invest $150 million.

Contract Pharma Staff 11.16.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Fujifilm Cellular Dynamics, Lonza Enter Cell Therapy Pact

Agree to expand availability and use of induced pluripotent stem cell technology.

Contract Pharma Staff 11.16.20

Clinical Trials | Information Technology

AI and Advanced Analytics

Equipped with the right tools, CROs are better positioned to develop optimal protocols, rapidly identify patients to enroll, and preempt study issues.

Paul Oliver, Medidata 11.13.20

Clinical Trials | Information Technology

eCOA: Addressing Barriers to Faster Deployment in Clinical Trials

Clinical Outcome Assessments are an increasingly important tool in clinical research.

Paul O'Donohoe, Scientific Lead, eCOA and Mobile Health, Medidata 11.13.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings

Swissmedic Begins Rolling Review of Moderna’s mRNA COVID-19 Vax

Moderna completed enrollment of its Phase 3 COVE study of mRNA-1273 on October 22.

Contract Pharma Staff 11.13.20

Breaking News | Collaborations & Alliances | Industry News

AzurRx BioPharma Partners with Asymchem

Will develop and produce MS1819 for the treatment of exocrine pancreatic insufficiency.

Contract Pharma Staff 11.12.20

Bio News | Breaking News | Facilities | Industry News

Stelis BioSource Continues Facility Investment

Will install two 2,000L single-use bioreactor trains in its mammalian CGMP facility.

Contract Pharma Staff 11.12.20

CCRM and McMaster Innovation Park (MIP) Partner to Build and Operate Biomanufacturing Campus

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Bioanalytical Services | cGMP Manufacture | Drug Development | Scale-up/Technology Transfer

CDMOs: Keeping up with Science & Technology

Enhancing the development of increasingly advanced and complex drug candidates is needed to drive growth in the industry.

Kristin Brooks, Contract Pharma 11.12.20

Lyophilization

LSNE Contract Manufacturing – The Recognized Leader in Lyophilization and Sterile Manufacturing

A history of execution. A reputation for excellence.

Biologics, Proteins, Vaccines | Breaking News | Promotions & Moves

Novavax Makes Leadership Changes

Appoints Gregory F. Covino as executive vice president and chief financial officer.

Contract Pharma Staff 11.11.20

Breaking News | Industry News

Pfizer, BioNTech to Supply 200M Doses of BNT162b2 to EU

Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization.

Contract Pharma Staff 11.11.20

Breaking News | Industry News

TCR² Therapeutics, ElevateBio Expand TC-210 Mfg. Capacity

Strategic partnership will leverage technical capabilities at ElevateBio for the production of TC-210 to support Phase II clinical trial.

Contract Pharma Staff 11.11.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Altimmune Adds Lonza as Mfg. Partner for Supply of AdCOVID

Single-dose intranasal vaccine for COVID-19 designed to generate a broad immune response with nasal mucosal immunity to prevent infection and transmission.

Contract Pharma Staff 11.11.20

Breaking News | Collaborations & Alliances | Drug Delivery | Industry News | Parenterals

Ypsomed Collaborates with Schott and Lonza

Aims to deliver a comprehensive solution for wearable patch injectors.

Contract Pharma Staff 11.10.20

Breaking News | CRO News | Industry News | Information Technology

RhoFED Wins BARDA Contract

Will serve to standardize data collection, management, and analysis across BARDA-supported network studies.

Contract Pharma Staff 11.10.20

AC Immune and WuXi Biologics Expand Strategic Partnership

Plan to accelerate AC Immune’s TDP-43 antibody into clinical development.

Contract Pharma Staff 11.10.20

Breaking News | CRO News | Drug Discovery | Industry News

MercachemSyncom Acquires Admescope

Significantly expands its capabilities for in vitro and in vivo studies.

Contract Pharma Staff 11.10.20

Pharmaceutical Logistics Company Expands in San Antonio

WDSrx expands into San Antonio providing pharmaceutical warehousing and logistics from 1310 Cornerway Boulevard.

Contract Pharma Staff 11.10.20

Bioassay Development | Breaking News | Industry News

GenScript Gets EUA for SARS-CoV-2 Neutralizing Antibody Detection Kit

cPass SARS-CoV-2 Neutralization Antibody kit is the only EUA authorized virus-free testing assay that detects neutralizing antibodies within an hour.

Contract Pharma Staff 11.10.20

Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News

Altimmune Adds Lonza as a Manufacturing Partner

For supply of AdCOVID, its single-dose intranasal vaccine candidate for COVID-19.

Contract Pharma Staff 11.10.20

Breaking News | Drug Development | Promotions & Moves

Inozyme Pharma Appoints SVP, Regulatory Affairs

Dr. Kevin B. Johnson brings over 25 years of experience to the role.

Contract Pharma Staff 11.09.20

Breaking News | Collaborations & Alliances | Drug Development

PhoreMost, Oxford Biomedica Enter CAR-T Collaboration

Aims to develop next-gen CAR-T cell therapies leveraging SITESEEKER and LentiVector platforms.

Contract Pharma Staff 11.09.20

Breaking News | Industry News | Packaging & Tracking

Rondo-Pak Expands Capacity at Primary Facilities

Newly incorporated equipment includes a Koenig & Bauer Iberica Optima 106 Die-Cutter and a Bobst Expertfold 110 Folder-Gluer.

Contract Pharma Staff 11.09.20

Breaking News | Collaborations & Alliances | Drug Development | Industry News

OM Pharma and AstraZeneca Sign Collaboration Agreement

Will improve the accessibility of Broncho-Vaxom and accelerate its growth in the Chinese market.

Contract Pharma Staff 11.06.20

Argonaut Manufacturing Services Completes First cGMP Run

New automated aseptic fill/finish line for clinical and commercial use was recently approved by regulators.

Contract Pharma Staff 11.06.20

Fareva Expands Sterile Production Capabilities

Grows footprint with site acquisition in France and Austria.

Contract Pharma Staff 11.06.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Novavax to Supply COVID-19 Vaccine Candidate to Australia

Delivery will start as early as the first half of 2021.

Contract Pharma Staff 11.05.20

Breaking News | Facilities | Industry News

Eurofins CDMO Expands Drug Product Capabilities in Canada

14,500 sq. ft. expansion includes new development labs and GMP manufacturing suites.

Contract Pharma Staff 11.05.20

Financial Reports

Financial Report: Merck

Pharmaceutical sales were up 2% to $11.3 billion in the quarter, driven primarily by growth in oncology and certain hospital acute care products.

Contract Pharma Staff 11.04.20

Excipients

Pharmaceutical Excipients Market Poised for Growth

The global pharmaceutical excipients market is estimated to surpass $11,944.6 million by 2027.

Contract Pharma Staff 11.03.20

Good Clinical Practice: Practical Application and Implementation

...

11.03.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

TFF Expands Engagement with Experic

Agrees to install a TFF processing line and its associated capabilities at Experic’s cGMP facility in NJ.

Contract Pharma Staff 11.03.20

The Virtual Conference on Clinical Studies with Medical Devices and IVDs

...

11.03.20

Clinical Trial Registration: Requirements, Record Maintenance and Reporting of Results

...

11.03.20

Breaking News | Collaborations & Alliances | Drug Development | Industry News

Sensorion and Novasep Sign Agreement

Covers the development and manufacturing of AAV vectors, a key step for Sensorion’s gene therapy programs.

Contract Pharma Staff 11.03.20

30-Hour Clinical Research Auditing Certification Program

...

11.03.20

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

...

11.03.20

Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs

...

11.03.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Sanofi to Acquire Kiadis for $359M

Adds next-gen natural killer cell platform and pipeline of cell-based cancer immune-therapeutics and infectious disease therapies.

Contract Pharma Staff 11.03.20

Breaking News | CRO News | Facilities | Industry News | R&D

Reach Separations Expands Nottingham Premises

Responds to increased demand for its chiral purification services.

Contract Pharma Staff 11.03.20

Bio News | Breaking News | cGMP Manufacture | Industry News

eTheRNA Extends mRNA Production Services

Adds high throughput research grade mRNA to its GMP capabilities.

Contract Pharma Staff 11.03.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Novartis Expands Kymriah Manufacturing Footprint

Gets green light for commercial CAR-T cell therapy manufacturing site in Asia.

Contract Pharma Staff 11.03.20

cGMP Manufacture | Fill/Finish | Scale-up/Technology Transfer

Ramping Up COVID-19 Vaccine Fill and Finish Capacity

As a partner to the U.S. Government, GRAM's newest facility was designed to increase large-scale fill and finish capacity with room to expand as demand grows.

Kristin Brooks, Contract Pharma 11.03.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

Fusion Pharma, AstraZeneca Enter Radiopharmaceuticals Alliance

Leverages Fusion's Targeted Alpha Therapies platform and radiopharmaceuticals expertise and AstraZeneca's portfolio of antibodies and cancer therapies.

Contract Pharma Staff 11.02.20

Breaking News | Industry News

Samsung Biologics, Checkpoint Therapeutics Expand Cosibelimab Mfg. Pact

Samsung Biologics will provide additional commercial-scale drug substance manufacturing.

Contract Pharma Staff 11.02.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Minaris Invests $64.5M to Expand Cell and Gene Mfg. Facilities

New buildings near Munich, Germany and Yokohama, Japan will more than double capacity for commercial manufacturing of regenerative medicines.

Contract Pharma Staff 11.02.20

Breaking News | Promotions & Moves

Lonza Appoints CEO

Pierre-Alain brings more than 20 years of experience in biopharmaceuticals.

Contract Pharma Staff 11.02.20

Breaking News | Industry News | Promotions & Moves

Frontida BioPharm Names Steven Roese as Vice President, Quality

...

Contract Pharma Staff 10.30.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Lonza to Manufacture AstraZeneca's COVID-19 Long-Acting Antibody Combination

cGMP manufacturing of the two long-acting antibodies to begin in H1 2021 at Lonza's Portsmouth, NH (USA) site.

Contract Pharma Staff 10.30.20

Breaking News

Syneos Health Agrees to Acquire Synteract

Enhances Syneos Health’s position across the fast-growing small to mid-sized category.

Contract Pharma Staff 10.29.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances

AB2 Bio and WuXi Biologics Enter Collaboration

Set-up and accelerate commercial-scale manufacturing of Tadekinig alfa.

Contract Pharma Staff 10.29.20

Financial Reports

Financial Report: PPD

Clinical Development Services revenue up 19% to $1.0 billion in the quarter.

Contract Pharma Staff 10.29.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Catalent to Acquire Bone Therapeutics’ Cell Therapy Mfg. Facility

Expands cell therapy capabilities and advanced clinical and commercial supply, and creates an integrated European CoE.

Contract Pharma Staff 10.29.20

Breaking News | Clinical Trials | CRO News

BARDA Reselects ICON as Preferred Partner

Continues as part of BARDA’s exclusive Medical Countermeasures Clinical Studies Network

Contract Pharma Staff 10.29.20

Breaking News | Financial Reports

Financial Report: Gilead

Veklury (remdesivir) revenues were $873 million in the third quarter.

Contract Pharma Staff 10.28.20

Breaking News | Industry News

MilliporeSigma Awards Grant to Combined Therapeutics

Supports its nucleic acid platform that targets liver cancer with virotherapy.

Contract Pharma Staff 10.28.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

SB3000 Partners with Evaxion

Provides rapid scale up for commercial production of coronavirus vaccines.

Contract Pharma Staff 10.28.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Bayer to Pay up to $4B for Gene Therapy Firm AskBio

Purchase includes an established CDMO, lays the foundation for future partnerships in the area of AAV therapies.

Contract Pharma Staff 10.28.20

Breaking News | Industry News | Promotions & Moves

Valicare Expands Service Portfolio

Recruits Dr. Christin Erbach as senior GMP consultant.

Contract Pharma Staff 10.28.20

Sai Life Sciences to Expand Biology Capabilities

Begins construction of new 75,000 sq. ft. facility in Hyderabad; adding 170 biologists to team.

Contract Pharma Staff 10.28.20

Breaking News | Industry News | Promotions & Moves

DCAT Elects New President

Sean Diver will serve a one-year term, ending October 31, 2021.

Contract Pharma Staff 10.28.20

Breaking News | Fill/Finish | Parenterals

TurboFil Introduces Syringe Filling & Assembly System

New module is automated and designed for simplified production for a wide range of syringe formats.

Contract Pharma Staff 10.27.20

Breaking News | Clinical Trials

Thermo Fisher Expands Direct-to-Patient Service

Offering now includes Clinical Site-to-Patient, Pharmacy-to-Patient and Depot-to-Patient services to enable medication delivery directly to patients' homes.

Contract Pharma Staff 10.27.20

Breaking News | Collaborations & Alliances | Drug Development

BioInvent, CASI Pharmaceuticals Enter Antibody Alliance

Collaboration accelerates and expands BioInvent's global development plans for BI-1206 in liquid and solid tumors.

Contract Pharma Staff 10.27.20

Breaking News | Industry News

Stevanato, Catalent Partner to Expedite Equipment Installation

Stevanato’s high-speed visual inspection machines will support biologic and vaccine programs at Catalent manufacturing sites in U.S. and Italy.

Contract Pharma Staff 10.27.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances

REGENXBIO Achieves $80M Novartis Milestone

Zolgensma, which leverages REGENXBIO's NAV AAV9 vector, reaches $1 billion in sales.

Contract Pharma Staff 10.27.20

Breaking News | Collaborations & Alliances | Facilities | Industry News

Construction Starts on the Medicines Manufacturing Innovation Center

Will offer next-gen solutions in small molecule and pharmaceutical manufacturing.

Contract Pharma Staff 10.26.20

Breaking News | Collaborations & Alliances

Elsevier, Novartis Collaborate on Risk Assessment Prediction Tool

To develop a safety margin risk assessment prediction tool, largely using PharmaPendium data.

Contract Pharma Staff 10.22.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances

Kamada Signs Supply Agreement with Israeli Health Authorities

Will provide investigational Covid-19 plasma-derived Immunoglobulin.

Contract Pharma Staff 10.22.20

Breaking News | cGMP Manufacture | Drug Development | Industry News

Roche, Atea Pharma to Develop Potential Oral COVID-19 Treatment

To develop, manufacture and distribute AT-527, Atea’s investigational oral direct-acting antiviral being studied to treat COVID-19.

Contract Pharma Staff 10.22.20

Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News | Scale-up/Technology Transfer

Catalent, BrainStorm Enter ALS Drug Manufacturing Pact

Catalent will undertake the transfer of the manufacturing process to, and provide future cGMP clinical supply of NurOwn from its Houston facility.

Contract Pharma Staff 10.22.20

ProBioGen, Heidelberg Pharma Ink ATAC Agreement

ProBioGen is conducting cell line development, process development and GMP manufacturing of the mAb intermediates of Heidelberg’s ATAC molecules for cancer.

10.22.20

Breaking News | cGMP Manufacture | Industry News

Lonza Expands Capsule Mfg. Capacity

$93 million investment to expand production capacity of capsules in CHI's Capsugel portfolio by 30 billion capsules annually, or 15%.

10.22.20

Breaking News | Industry News | Promotions & Moves

Metrics Contract Services Expands Business Development Team

Names Lettie Kirk as business development executive.

Contract Pharma Staff 10.21.20

Facilities

Vetter Moves Into New HQ

€50 million investment integrates the latest construction and environmental standards.

Contract Pharma Staff 10.21.20

CDMO QCL Expands Fill Finish Capabilities

Partners with AST on flexible, isolated fill finish equipment for new facility expansion.

Contract Pharma Staff 10.21.20

Biologics, Proteins, Vaccines

India Emerges as Hot Spot for Manufacturing COVID-19 Vaccines

CMOs expand and ‘repurpose’ capacities.

S Harachand, Contributing Editor 10.20.20

Clinical Trials | Drug Development | Preclinical Outsourcing

Accelerating R&D Trends

The pandemic has propelled lingering trends into the forefront and increasingly complex molecules and biologics have drug developers outsourcing more.

Kristin Brooks, Contract Pharma 10.20.20

APIs | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

JSR Life Sciences Expands European Footprint

Will co-locate primary European operations for affiliate companies KBI Biopharma and Selexis SA in Geneva’s ZIPLO campus.

10.20.20

Breaking News | Clinical Trials

CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin

Phase 2 trial will commence during the first quarter of 2021.

Contract Pharma Staff 10.20.20

Breaking News | Clinical Trials | Collaborations & Alliances

Cytocom and Cleveland Biolabs Merge

Combine their businesses in an all-stock transaction.

Contract Pharma Staff 10.20.20

Breaking News | Trials & Filings

Valneva’s Chikungunya Vax Granted PRIME Designation

Becomes the first company worldwide to advance a chikungunya vaccine candidate into Phase III.

10.20.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

CEVEC, Rznomics Ink License Agreement for CAP Technology

Rznomics will use CEVEC’s cell line technology with its trans-splicing ribozyme technology for manufacturing gene therapies targeting various cancers.

10.20.20

Breaking News | Clinical Trials

Mereo Makes Leadership Changes

Appoints CFO and SVP, regulatory affairs.

Contract Pharma Staff 10.20.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

Samsung Biologics, Dinona Partner on Potential COVID-19 Antibody Therapy

Will collaborate for fast-track development of DNP-019, a potential COVID-19 antibody therapy.

10.20.20

Breaking News | Cytotoxics and High Potency Manufacturing | Facilities | Industry News

CordenPharma Colorado Completes Highly Potent API Lab Expansion

Capable of handling highly potent compounds with an OEL as low as 1ng/m3.

Contract Pharma Staff 10.19.20

Bio News | Breaking News | Facilities | Industry News | Parenterals

INCOG BioPharma Launches Central Indiana Ops

New CDMO is investing roughly $60 million to construct and equip a 60,000-square-foot facility in Fishers.

Contract Pharma Staff 10.19.20

Breaking News | Industry News

Arcinova Installs R1000 Robotic Capsule Filler

Increases production to 1000 units per hour, while maintaining the same level of operator labor.

Contract Pharma Staff 10.19.20

Promotions & Moves

Touchlight Appoints CEO

Karen will work to further expand the company's contract manufacturing business, which delivers GMP materials to third parties developing COVID-19 vaccines.

Contract Pharma Staff 10.16.20

Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Drug Development | Industry News

J&J Pauses All Trials Evaluating COVID-19 Vax Candidate

Temporarily pauses further dosing in all COVID-19 vaccine candidate trials to investigate an an unexplained illness.

Contract Pharma Staff 10.16.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Lilly Pauses ACTIV-3 Clinical Trial in Hospitalized COVID-19 Patients

ACTIV-3 study is evaluating the efficacy of Lilly’s neutralizing antibody in hospitalized COVID-19 patients, the most advanced stage of the disease.

Contract Pharma Staff 10.16.20

Biologics, Proteins, Vaccines | Breaking News | Industry News | Promotions & Moves

The Discovery Labs Appoints President and COO

Taps former Lonza Exec, Jeorg Ahlgrimm.

Contract Pharma Staff 10.15.20

Breaking News | Capsules | Facilities | Industry News | Solid Dosage/Creams/Ointments

Sirio Europe Invests in Advanced Manufacturing and Green Technologies

Manufacturing facility upgrades at Brandenburg site have increased the CDMO’s production capacity and energy efficiency.

Contract Pharma Staff 10.15.20

Clinical Trials | Information Technology

The Role of Electronic Monitoring in Maintaining Medication Adherence

Digital solutions offer hope to get patients to take their medications properly.

Bernard Vrijens, Scientific Lead, AARDEX Group 10.14.20

APIs

Understanding the Importance of Crystallization Processes

Crystallization is a crucial aspect of a molecule’s development and can be used to avoid unnecessary cost, risk and development delays.

Dr. Craig Callahan, Project Scientist, Cambrex Edinburgh 10.14.20

Capsules | Solid Dosage/Creams/Ointments

Capsule Technology Trends

A look at the capsule market with a particular focus on the factors driving increased demand in non-gelatin-based formulations.

Julien Lamps, Product Manager, Lonza 10.14.20

Aseptic Processing | Fill/Finish

A Holistic Cleanroom Concept: Higher Quality and Greater Flexibility

Overcoming today’s aseptic fill-and-finish process challenges.

Ute Schleyer, Project Manager, Site & Plant Development, Vetter 10.14.20

Breaking News | Collaborations & Alliances | Industry News

RedHill Biopharma Ramps-Up Manufacturing of Opaganib

Collaborates with specialty manufacturers in Europe and Canada.

Contract Pharma Staff 10.14.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Dyno, Roche Ink Gene Therapy Deal Worth up to $1.8B

Collaboration combines Dyno’s AI-powered AAV vector capabilities with Roche and Spark Therapeutics’ gene therapy capabilities.

Contract Pharma Staff 10.14.20

The Pandemic’s Become an Insurmountable Opportunity

Every Cloud has a Silver Lining(?)

Emil W. Ciurczak, Contributing Editor 10.14.20

Breaking News | Facilities | Industry News

NewAge Industries-AdvantaPure Expands on Recent Purchase of Additional Facility

Will increase critical tubing and molding capacities.

Contract Pharma Staff 10.14.20

Analytical Services | Bioanalytical Services | Breaking News | Industry News | Laboratory Testing

PPD to Open Multipurpose Clinical Research Lab in Suzhou

Will offer bioanalytical, biomarker and vaccine services for global and China-based biopharma customers.

10.14.20

Bio News | Breaking News | Facilities | Industry News

CellGenix Expands Facility

Meets the growing demand for GMP raw materials.

Contract Pharma Staff 10.13.20

Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News

Greenwich Lifesciences Completes Manufacturing of GP2

The active ingredient is ready for its planned Phase III clinical trial.

Contract Pharma Staff 10.13.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

KindredBio Expands Manufacturing Agreement with Vaxart

Centaur will manufacture Vaxart’s oral vaccine for COVID-19 and other vaccine candidates.

Contract Pharma Staff 10.13.20

Breaking News | Collaborations & Alliances | Industry News

BryoLogyx Completes World’s First GMP Synthesis of Bryostatin-1

Partnered with CDMO AMRI for GMP synthesis.

Contract Pharma Staff 10.13.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Fujifilm Diosynth to Manufacture Lilly COVID-19 Antibody

Commercial manufacturing of the antibody therapy is expected to commence in April 2021.

Contract Pharma Staff 10.13.20

Breaking News | Facilities | Industry News | Injectables | Packaging & Tracking

Sharp Invests $10M in Biologics, Injectables Packaging Equipment

Investment includes the installation and validation of two Dividella NeoTopx packaging systems.

Contract Pharma Staff 10.13.20

Breaking News | Industry News | Inspections

Symbiosis Completes MHRA Regulatory Inspection

Scottish CMO recorded no critical or major observations from the reinspection by the MHRA.

Contract Pharma Staff 10.13.20

Clinical Trials | Information Technology

Adding Remote Site Access to Sponsor Bids: What to Know as CRO

Traditional monitoring has changed, CROs should build a portfolio of remote access solutions and have them ready.

Ryan Jones, CEO, Florence Healthcare 10.13.20

cGMP Manufacture | Drug Development | Promotions & Moves

AGC Biologics Appoints New GM of Milan Site

Luca Alberici will initiate integration efforts resulting from the July 2020 acquisition of MolMed.

Contract Pharma Staff 10.12.20

Abzena Invests $60M Into cGMP Manufacturing Capacity

New facility in San Diego houses a process development laboratory and two new cGMP manufacturing cleanrooms.

Contract Pharma Staff 10.08.20

Biologics, Proteins, Vaccines | Breaking News | Industry News

Mapi Pharma Commissions Facility to Support Supply of COVID-19 Vaccines

Makes available its production, cold-chain and storage capacities for the delivery of vaccines to Israel and the EU.

Contract Pharma Staff 10.08.20

Breaking News | Collaborations & Alliances | CRO News

BARDA Selects Pharm-Olam for Clinical Trial Planning & Execution Services

Will support new medical countermeasure research in the fight against emerging infectious disease.

Contract Pharma Staff 10.08.20

Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments

NextPharma Expands OSD Capacity

Invests €15 million to increase oral solid dosage form manufacturing and packaging capacity at its Goettingen site.

Contract Pharma Staff 10.08.20

Biologics, Proteins, Vaccines | Breaking News | Drug Delivery | Industry News

HHS Funds Development of Needle-free Vax Technology

Patch could administer vaccines without traditional needles reducing the need for refrigeration in transport and storage, and possibly self-administration.

Contract Pharma Staff 10.07.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Recipharm, Arcturus Ink LUNAR-COV19 Vax Mfg. Pact

Recipharm to support the manufacture of ARCT-021, Arcturus’ COVID-19 vaccine candidate that is in an ongoing Phase I/II clinical trial.

Contract Pharma Staff 10.07.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Lilly Submits EUA Request for COVID-19 Monotherapy

LY-CoV555 and LY-CoV016 combination therapy significantly reduced viral load at day 11, meeting the primary endpoint of the study.

Contract Pharma Staff 10.07.20

Biologics, Proteins, Vaccines | Breaking News

Kindred Bio Expands Agreement with Vaxart

Centaur will manufacture Vaxart’s oral vaccine for COVID-19 and other vaccine candidates.

Contract Pharma Staff 10.07.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Eisai Enters Joint Development Agreement for COVID-19 Therapeutics

Aims to understand the mechanism of COVID-19 aggravation based on SARS-CoV-2 infection and to create drugs that prevent the aggravation of COVID-19.

Contract Pharma Staff 10.07.20

Biologics, Proteins, Vaccines | Breaking News

FDA Issues Guidance on EUA for COVID-19 Vaccines

Provides further information on the EUA process for investigational vaccines.

Contract Pharma Staff 10.07.20

Breaking News | R&D

Samsung Biologics Adopts Solentim Solutions in R&D Center

Solentim’s instruments will be used in conjunction with Samsung Biologics’ proprietary cell line platform.

Contract Pharma Staff 10.07.20

Biologics, Proteins, Vaccines | Breaking News | Industry News | Laboratory Testing

CEPI Establishes Global Lab Network to Assess COVID-19 Vax Candidates

Will use the same testing reagents to assess and compare the immunological responses generated by COVID-19 vaccine candidates.

Contract Pharma Staff 10.07.20

Breaking News | Collaborations & Alliances | Industry News

Irisys Signs Contract with TFF Pharma

Will produce medication to treat lung conditions, including COVID-19.

Contract Pharma Staff 10.06.20

Breaking News | Drug Delivery | Industry News | Solid Dosage/Creams/Ointments

Evonik Launches New Oral Drug Delivery Technology

For enteric protection and rapid release in the upper small intestine.

Contract Pharma Staff 10.06.20

Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News | Preclinical Outsourcing

Ocugen Engages Kemwell Biopharma for cGMP Manufacture of OCU200

Paves the way towards getting OCU200 in the clinic by first half of 2022.

Contract Pharma Staff 10.06.20

Breaking News | Facilities | Industry News

Sterling Pharma Solutions Opens Material Science Center

Offers specialist solid state chemistry and milling services.

Contract Pharma Staff 10.06.20

Parenterals

Primary Packaging Considerations Amid COVID-19 Vax Urgency

Fran L. DeGrazio of West discusses why and how vaccine development is different than drug development and the impacts of COVID-19 on vaccine development.

Kristin Brooks, Contract Pharma 10.05.20

Breaking News | Drug Development | Industry News

BMS to Acquire MyoKardia for $13.1B

Promising portfolio of pipeline candidates strengthens and extends BMS’ cardiovascular franchise.

Contract Pharma Staff 10.05.20

Reader Showcase

Thermo Fisher Scientific Launches Service for Ultra-Low Temp TSX Freezers

Smart connected services enables active sample and product protection.

Contract Pharma Staff 10.05.20

Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Cobra Biologics to Manufacture Plasmids for COVID-19 Vax Trial

Collaboration will ensure GMP production of material for Phase I clinical trial of Scancell’s DNA vaccine against SARS-CoV-2.

Contract Pharma Staff 10.05.20

Breaking News | Promotions & Moves

3P Expands Management Team

Adds José Luis Bartolomé as operational excellence and continuous improvement director.

Contract Pharma Staff 10.02.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

FibroGenesis Collaborates with R4D Biotech

Expands the fight against COVID-19 in Brazil.

Contract Pharma Staff 10.02.20

Siegfried Acquires Two Pharma Manufacturing Sites from Novartis in Spain

Sites are specialized in the manufacturing of ophthalmic steriles as well as oral solid dosage forms and capsules used in inhalation devices.

Contract Pharma Staff 10.02.20

APIs | Breaking News | Facilities | Industry News

Sterling Pharma Solutions Expands US Operations

Acquires Alcami’s Germantown, WI API facility.

Contract Pharma Staff 10.02.20

Breaking News | Drug Development

Olema Completes Series C Financing

Raises $85 million to advance clinical development of OP-1250 in breast cancer.

Contract Pharma Staff 10.01.20

Breaking News | Promotions & Moves

Bioclinica Establishes Medical and Scientific Affairs Organization

Expands Michael O’Neal’s role as chief medical officer.

Contract Pharma Staff 10.01.20

Breaking News | cGMP Manufacture | Formulation Development | Industry News | Scale-up/Technology Transfer

Catalent Launches OneXpress Solution

Aims to accelerate a program’s transition from early-phase development to commercial-ready manufacturing for oral dosage products.

Contract Pharma Staff 10.01.20

APIs | Breaking News | Industry News

NCK A/S Receives CoA for Berubicin API

CNS has a contract with NCK A/S for the large-scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors.

Contract Pharma Staff 10.01.20

Breaking News | cGMP Manufacture | Industry News | Parenterals | QA/QC

Lonza Expands QC Testing Portfolio

Launches PyroCell MAT System for in vitro Pyrogen testing to help ensure safety of parenteral pharmaceuticals during development, manufacture and release.

Contract Pharma Staff 10.01.20

Breaking News | cGMP Manufacture | Fill/Finish | Industry News

CRB Completes Large-Scale Mfg. Facility for GRAM

GRAM's newest facility was designed to increase its large-scale fill and finish capacity for COVID-19 vaccines and therapeutics.

Contract Pharma Staff 10.01.20

Breaking News | Clinical Trials | Collaborations & Alliances | Drug Development

Boehringer, Mirati Therapeutics Enter Clinical Collaboration

To evaluate the combination of BI 1701963, a SOS1::pan-KRAS inhibitor, and MRTX849, a KRAS G12C selective inhibitor in patients with solid tumors.

Contract Pharma Staff 09.17.20

Breaking News | Promotions & Moves

Boyds Bolsters Clinical Ops Team

Appoints senior clinical research associate.

Contract Pharma Staff 09.17.20

Six Strategies to Stretch Your Limited Drug Supply for Clinical Studies

The following six strategies can be used to find balance; nevertheless, they all require the support of a trusted clinical packager.

Capsules | Solid Dosage/Creams/Ointments

Beyond the Boundaries

New capsule types resolve emerging formulation needs.

Sven Stegemann, ACG Capsules 09.09.20

Sharp Bolsters Clinical Trials Services Capabilities

Launches Clinventory Inventory Management System (IMS) for clinical trials.

09.08.20

Clinical Trials | CRO News | Drug Development

PPD, Lupus Therapeutics to Support Lupus Clinical Research

To provide enhanced protocol and trial optimization capabilities for its customers leveraging LT’s scientific, operational and drug development expertise.

Contract Pharma Staff 09.04.20

Breaking News | Clinical Trials

GI Partners Acquires Clinical Ink

Plans to accelerate Clinical Ink’s innovation in clinical trial workflow solutions.

Contract Pharma Staff 08.27.20

Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances

Sutro Biopharma Achieves Merck KGaA Clinical Supply Milestone

Delivers GMP clinical trial supply to Merck KGaA for Phase 1 trial of M1231, a bispecific ADC for the treatment of solid tumors.

Contract Pharma Staff 08.25.20

Clinical Trials | Drug Development

Beyond 2020: The Future of CROs

How will remote site access impact the CRO business?

Ryan Jones, CEO, Florence Healthcare 08.21.20

Clinical Trial Financial Management

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08.20.20

Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News

JanOne Readies for Clinical GMP Manufacturing Run

JAN101 formulation ready for Phase 2b peripheral artery disease trials and for potential treatment of COVID-19 vascular inflammation.

Contract Pharma Staff 08.20.20

Clinical Project Management: Fundamentals of Project Management

...

08.20.20

Auditing Techniques for Clinical Research Professional

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08.20.20

Introduction to Clinical Research

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08.20.20

Conducting Clinical Trials Under ICH GCP E6

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08.20.20

Monitoring Clinical Drug Studies: Beginner

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08.20.20

Importing Clinical Supplies into China

Water Cooler Chat

Breaking News | Facilities

Heritage Global and Federal Equipment Company to Conduct Auction of Manufacturing Site

Online auction features processing and lab equipment.

Contract Pharma Staff 07.31.20

PCI Pharma Services Announces Global Expansion of Clinical Trial Services

PCI Broadens Global Clinical Supply-Chain Service Offerings Into Mainland Europe

Breaking News | Clinical Trial Materials | Cold Chain Management | Industry News

PCI Pharma Services Expands with New Clinical COE in Berlin

17,000 sq.-ft. flagship site dedicated to primary and secondary packaging, storage at all temperature ranges, and distribution.

Contract Pharma Staff 07.28.20

Introduction to PCI Clinical Trial Services

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Importing Clinical Supplies into Japan

Water Cooler Chat

Bio News | Breaking News | Clinical Trial Materials | Facilities | Industry News

Catalent Expands Clinical Manufacturing Operations

Invests $30 million to create European clinical manufacturing center of excellence in Limoges, France.

Contract Pharma Staff 07.21.20

Breaking News | Clinical Trials

University of Oxford Selects Axiom eClinical Suite for Clinical Trial

Will focus on COVID-19 preventative treatments.

Contract Pharma Staff 07.07.20

Breaking News | Industry News

iBio Receives IBM Clinical Development Solution

Designed to support clinical COVID-19 vaccine candidates.

Contract Pharma Staff 06.30.20

Breaking News | Drug Development | Industry News

Oncology Venture Out-Licenses Clinical Assets to Smerud

Smerud will advance development of LiPlaCis in late stage metastatic breast cancer and 2X-111 in glioblastoma multiforme.

Contract Pharma Staff 06.29.20

Breaking News | Clinical Trials | CRO News | Drug Development

LabCorp Introduces Xcellerate COVID-19 Clinical Study Solution

Offers integrated data collection, actionable views of critical study data, COVID-19 targeted risk management and recovery assessment.

Contract Pharma Staff 06.29.20

Breaking News | Industry News

FUJIFILM Wako Introduces PYROSTAR® ES-F Line to U.S.

A line of reagents engineered to detect the presence of bacterial endotoxins.

Contract Pharma Staff 06.26.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development

SwiftScale Manufactures COVID-19 Antibody Candidate

Uses rapid biologics manufacturing technology to accelerate development of treatments.

Contract Pharma Staff 06.09.20

Drug Delivery

Not Your Father’s Oral Thin Film

A look at how oral film drug delivery is evolving.

Rodolphe Obeid, Vice President of Operations, IntelGenx 06.04.20

APIs | cGMP Manufacture | Clinical Trials | Supply Chain

Evaluating Pharma Amid COVID-19

Dr. Ural of Ernst & Young LLP discusses market dynamics, enduring therapeutic areas, near term M&A, and how industry can use this time for transformation

Kristin Brooks, Contract Pharma 05.18.20

Clinical Trials

Pioneering Medicine Forward

May 20th marks Clinical Trials Day, celebrating 273 years of clinical trials

Tina Bland, Senior Consultant, KCR Trial Execution Consulting 05.18.20

cGMP Manufacture | Clinical Trials | Drug Development | Information Technology | R&D

COVID-19’s Long-Term Impact on Drug Development: The New Pragmatism

The rise of new tools and approaches, an increase in regulatory responsibility, and the need for speed.

Paul Bridges SVP Worldwide Head Regulatory & Access, Parexel and Sheela Hegde, Partner and Managing Director, Health Advances 05.18.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

WuXi Launches CAR-T Cell Therapy Platform

Will enable biotechnology companies and researchers to accelerate the development, manufacturing and release of cell and gene therapies for patients

Contract Pharma Staff 05.18.20

Breaking News | Collaborations & Alliances | Industry News

Duke, GenScript, A*STAR Enter COVID-19 Pact

Launch SARS-CoV-2 serology test to detect neutralizing antibodies without need of containment facility or specimen

Contract Pharma Staff 05.18.20

Breaking News | Facilities | Industry News | Inspections

PharmaCyte Conducts Final Audit of Mfg. Facility

Batch records in Thailand have been deemed cGMP compliant

Contract Pharma Staff 05.18.20

Breaking News | Drug Development | Industry News

VSY Biotech Develops TR-C 19 Candidate to Treat COVID-19

Studies have shown that TR-C 19 can neutralize the virus isolated under lab conditions, clinical trials are underway.

Contract Pharma Staff 05.15.20

Industry News

FDA COVID-19 Update

To date, the FDA has authorized 98 tests under EUAs, which include 85 molecular tests, 12 antibody tests, and 1 antigen test.

Contract Pharma Staff 05.15.20

Exyte and Univercells Join Forces

Partner for rapid deployment of vaccine production plants in the wake of the COVID-19 crisis

Contract Pharma Staff 05.14.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

CMAB Completes Devt. and Mfg. Project for QureBio

Bispecific antibody Q-1802 will enter clinical trials to assess treatment of solid tumors such as gastric cancer

Contract Pharma Staff 05.14.20

Vibalogics to Manufacture Clinical Material for Janssen

CDMO to provide additional clinical trial material for COVID-19 vaccine candidate

Contract Pharma Staff 05.14.20

Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News

Sabin and ReiThera Enter Clinical Manufacturing Pact

BARDA provides the Sabin Vaccine Institute with additional $20mn for further development of Ebola Sudan and Marburg vaccines

Contract Pharma Staff 05.14.20

Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery

FairJourney Biologics Joins Forces with Iontas

Create a global platform for outsourced antibody discovery services.

Contract Pharma Staff 05.13.20

Breaking News | Formulation Development | Industry News | Solid Dosage/Creams/Ointments

Catalent, Ennaid Therapeutics Ink COVID-19 Program Pact

Catalent will develop a powder-in-capsule formulation of Ennaid’s ENU200 program, a repurposed antiviral drug for the potential treatment of COVID-19

Contract Pharma Staff 05.13.20

Bioassay Development

QPS Announces COVID-19 Testing Capability

Developed a QPCR assay to identify active novel coronavirus infections.

Contract Pharma Staff 05.13.20

APIs | Breaking News | cGMP Manufacture | Excipients | Industry News

Evonik Commissions Advanced Biomaterials Production Facility

Expands range of CMO services for the scale-up and commercial manufacturing of customer’s own excipients in Birmingham, AL.

Contract Pharma Staff 05.13.20

Breaking News | Clinical Trial Materials | Industry News | Logistics | Supply Chain

Marken Expands Direct To Patient Services

India allows home delivery of clinical trial medications during COVID-19 pandemic lock down.

Contract Pharma Staff 05.13.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Singota Solutions Collaborates with Noveome Biotherapeutics

To manufacture therapy to treat severe condition in people infected with COVID-19

Contract Pharma Staff 05.12.20

Yourway and Firma Ink Clinical Supply Deal

Collaborate to administer coordinated supply delivery for home-health clinical trial visits

Contract Pharma Staff 05.12.20

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Key Biologics and Astarte Biologics Rebrand

Will now be known as Cellero

Contract Pharma Staff 05.12.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Sarepta and Dyno Therapeutics Will Develop Next-Gen Gene Therapy Vectors

Dyno’s proprietary CapsidMap platform opens up new ways to identify novel capsids

Contract Pharma Staff 05.12.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

HJB, Mabspace Ink Development and Manufacturing Agreement

Program aims to bring more efficacious treatment options to cancer patients

Contract Pharma Staff 05.12.20

Breaking News | Clinical Trials | Industry News

Tufts CSDD Releases New Study

Establishes demographic benchmarks for pivotal clinical trials, showing areas of under-representation

Contract Pharma Staff 05.12.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Themis Collaborates with ABL Europe

ABL will manufacture Themis’ SARS-CoV-2 vaccine candidate in France

Contract Pharma Staff 05.12.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Junshi, Lilly to Develop Antibody Therapies for COVID-19

Multiple neutralizing antibodies have been engineered, with the lead asset poised to enter clinical testing in the second quarter

Contract Pharma Staff 05.12.20

Capsules | Fill/Finish | Solid Dosage/Semi-solids

Syntegon Hosts Virtual Show: New Technologies for Solid Dosage Forms

Launches Sepion Coater series in six sizes, continuous production from powder to capsule, and APD tool that determines optimum process parameters for capsules.

05.11.20

Viral aggregation in downstream processing of lentiviral vectors

...

Breaking News | cGMP Manufacture | Industry News

HCATS, Apceth Expand Manufacturing Pact with Bluebird Bio

Enter long-term development and manufacturing services agreements for clinical and commercial supply for multiple therapies.

Contract Pharma Staff 05.11.20

Collaborations & Alliances | Drug Development | Drug Discovery

Regeneron, CCPM Enter Genetics Research Alliance

Large-scale genomics initiative aims to advance human genetics and precision medicine

Contract Pharma Staff 05.11.20

Breaking News | Industry News

FDA COVID-19 Update

Authorizes the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing

Contract Pharma Staff 05.11.20

Catalent Provides Clinical Support for COVID-19 Study

Partners with Humanigen for FDA-approved Phase 3 lenzilumab study for COVID-19 patients

Contract Pharma Staff 05.08.20

Bio News | Breaking News | Clinical Trials | Industry News

Bioclinica Launches COVID-19 Clinical Endpoint Adjudication Solution

Designed to evaluate clinical trial protocol and charter to determine if novel COVID endpoint adjudication pathways should be added

Contract Pharma Staff 05.08.20

Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Reader Showcase

MilliporeSigma Launches Bio4C Software Suite

Bio4C digital ecosystem combines process control, analytics and plant-level automation

Contract Pharma Staff 05.07.20

Breaking News | Clinical Trials | Drug Development | Trials & Filings

Romark Initiates Trials of NT-300 for COVID-19 Prevention

In cell cultures, the active ingredient in NT-300, nitazoxanide, inhibits replication of a broad range of respiratory viruses, including SARS-CoV-2.

Contract Pharma Staff 04.27.20

Breaking News | Industry News

FDA COVID-19 Update

FDA issues a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine

Contract Pharma Staff 04.27.20

Breaking News | Drug Development | Industry News

Valo Tx Working to Develop Potential COVID-19 Vaccine

Will use PeptiCRAd technology with HLA-matched peptides optimized to further boost CD8+ T-cell immune responses.

Contract Pharma Staff 04.27.20

Clinical Trials | CRO News | Drug Development | Information Technology | R&D

CRO Industry Update

Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.

Kristin Brooks, Contract Pharma 04.27.20

Breaking News | Drug Development | Industry News

Santhera, CSHL to Investigate Lonodelestat in COVID-19-related ARDS

Lonodelestat (POL6014), a potent inhibitor of human neutrophil elastase (hNE), has potential as a therapeutic intervention for COVID-19-related ARDS.

Contract Pharma Staff 04.27.20

Breaking News | Drug Development | Industry News

AGC Biologics, AdaptVac Partner to Develop COVID-19 Vaccine

Will leverage AdaptVac's Virus-Like Particle (VLP) technology that could provide a solution to protect against new SARS-CoV-2 infections.

Contract Pharma Staff 04.27.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings

Regeneron, Sanofi Release Preliminary Phase II Kevzara Results in COVID-19

Kevzara rapidly lowered C-reactive protein (CRP), a key marker of inflammation, meeting the primary endpoint.

Contract Pharma Staff 04.27.20

New iPSC Master Cell Banks to Accelerate Development of Novel Cell Therapies

panCELLa and CCRM collaborate to benefit academia and industry

Quality-by-Design Approach to Manufacturing Cell and Gene Therapies

...

Clinical Trials | Information Technology | QA/QC

Managing Clinical Trials Amid the Coronavirus Pandemic

Patrick Hughes of CluePoints discusses the impact on clinical trials and how leveraging data may herald a long overdue paradigm shift in the industry.

Kristin Brooks, Contract Pharma 04.06.20

Clinical Trials | CRO News | Drug Development | Industry News | Information Technology

Janssen, PRA Design First Mobile Virtual Trial

Kent Thoelke and Greg Licholai of PRA discuss the alliance, advances that have made virtual clinical trials possible, and the obstacles that remain

Kristin Brooks, Contract Pharma 01.06.20

Breaking News | Drug Delivery | Drug Development | Industry News

Recipharm Invests in Inhalation Development Services

Installs SprayVIEW system to support inhalation and nasal product development at RTP, NC facility

12.09.19

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Navrogen, Lonza Enter Bio Production Deal

Sign agreement to use Lonza’s GS Gene Expression System for Navrogen’s anti-HIO targeting agents.

11.22.19

Industry News | Packaging & Tracking

Luminer Expands Primary Mfg. Facility

Brings the plant’s total space to 50,000 sq.-ft. and accommodates its growing extended content label (ECL) business

11.21.19

Federal Equipment's Adam Covitt

Federal Equipment's vice president was on hand at Contract Pharma 2019.

Breaking News | cGMP Manufacture | Industry News

ANI Launches New CDMO Brand ANI Global Source

Following the integration of WellSpring, the specialty CDMO will support late stage development and commercial manufacture of pharmaceutical products.

10.29.19

Clinical Trial Materials

Overcoming the Small Molecule Bioavailability Challenge

Approximately 90% of preclinical compounds are estimated to face bioavailability challenges.

David Lyon, Sr. Research Fellow, Lonza Pharma & Biotech 10.15.19

Drug Delivery | Industry News

CURE Pharmaceutical Expands Oral Drug Delivery Product Line

To expand manufacturing footprint by 50%, adding new blending, casting and packaging equipment in Oxnard, CA

10.09.19

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Prevail, Lonza Enter Development and Mfg. Alliance

Lonza will manufacture Prevail's AAV-based gene therapy programs for neurodegenerative diseases

10.08.19

Breaking News | Fill/Finish | Industry News

Alliance Contract Pharma Adds $2M Liquid Capsule Filling Line

New line has the capability of filling, banding and check weighing 80,000 to 120,000 capsules per hour

09.24.19

Cytotoxics and High Potency Manufacturing

API to ADC: A Journey Through High Potency

This class of compounds represents a major advance in oncology research and treatment application.

Maurits Janssen, Head Commercial Development API, Lonza Pharma & Biotech 09.16.19

Is Your Complex Formulation Process Set Up for Success?

Often, the implementation of specialized equipment and/or processes is necessary to ensure successful formulation.

APIs | Breaking News | Collaborations & Alliances | Industry News

CDMO Indena Improves Manufacturing Process

Jaguar Health's manufacturing partner to support expanded crofelemer manufacturing volume

08.14.19

Bio News | Breaking News | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer

Omeros, Lonza Enter Commercial Manufacturing Agreement

Builds on existing clinical supply deal for narsoplimab

07.31.19

Breaking News | Collaborations & Alliances | Industry News | Information Technology

Lonza Selects Rockwell Automation for Digital Pharma Ops

Will use PharmaSuite MES software, along with FactoryTalk InnovationSuite to accelerate paperless, 24/7 production of capsules

07.17.19

cGMP Manufacture | Industry News | Serialization

Lonza Completes $15M Tampa Site Expansion

The site now has a new Product Development & QC Lab area with 13 processing suites, two new packaging suites, serialization, and new manufacturing suites

07.10.19

Bio News | Breaking News | Facilities | Fill/Finish | Industry News

Lonza to Acquire Sterile Fill and Finish Facility from Novartis

First facility for Lonza’s Drug Product Services to cover sterile manufacturing for clinical production and commercial launches

07.01.19

Capsule Delivery Solutions from Lonza Pharma & Biotech

Capsule Delivery Solutions, part of Lonza Pharma & Biotech, is the leader in capsule-based solutions and services, proudly offering Capsugel® products.

Drug Delivery | Industry News