JML Consulting Group

CPhI Barcelona Event Info

...

10.03.23

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

Breaking News | Industry News | Promotions & Moves

Aprecia Names Owen Murray as Its CEO

Most recently served in VP role at Recordati Rare Diseases.

02.01.23

Breaking News | Promotions & Moves

Exothera Names Darren Leva as Chief Business Officer

Leva brings 20 years of broad commercial expertise to Exothera from a range of experiences with CDMOs, therapeutics, and software companies.

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

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

Breaking News | Financial Reports

Pfizer Revenues Soar to Record-Breaking $100B in 2022

Comirnaty and Paxlovid rake in $56.7 billion in 2022 while sales of these COVID products are expected to decline as much as 60% in 2023.

01.31.23

Breaking News | Facilities | Industry News

Lilly to Invest $450M at Manufacturing Site in Research Triangle Park

Expansion includes additional parenteral filling, device assembly and packaging capacity to support an increased demand for Lilly's incretin products.

01.30.23

Breaking News | Industry News | Laboratory Testing

Metrion Biosciences Expands into New Cambridge HQ

New 12,000 sq. ft. Cambridge, UK premises more than doubles lab space.

09.22.21

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 | cGMP Manufacture | Drug Development | Industry News

Everest Medicines, Sinovent, SinoMab Enter Global BTK Inhibitor Mfg. Pact

To develop, produce and commercialize XNW1011, a covalent reversible BTK inhibitor, globally for the treatment of renal diseases.

09.17.21

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

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 | Industry News

U.S. Govt. to Purchase Additional Doses of REGEN-COV Antibody Cocktail

Will supply an additional 1.4 million 1,200 mg doses of REGEN-COV to the U.S. government by January 31, 2022.

09.15.21

Breaking News | Information Technology

LabVantage Solutions Launches LabVantage Enterprise SaaS

Incorporates the advantages of LabVantage’s standard SaaS option, along with unprecedented software configurability and interfacing capabilities.

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

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

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

Breaking News | Promotions & Moves

Boyds Opens US Office in PA

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

09.13.21

Biologics, Proteins, Vaccines

COVID Booster Vaccines: What’s Next for FDA

FDA Atty comments on the ongoing vaccine rollout what we can expect for other COVID vaccines in development going forward.

09.13.21

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

GeneQuine, Exothera Enter Gene Therapy Partnership

To support the next stage of osteoarthritis gene therapy development program.

09.10.21

Breaking News | Collaborations & Alliances | Drug Development

GeneQuine Contracts Exothera to Support the Development of Its Osteoarthritis Gene Therapy

GQ-303, the gene therapy candidate, turns joint cells into factories for production of the therapeutic protein proteoglycan 4.

09.10.21

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

Let’s Get Genuine

LinkedIn sales pitches are going away in favor of being real.

David G. Jensen, 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

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

Logistics | Supply Chain

Maintaining Critical Drug Supply During COVID-19

Vincent Colicchio from Dr. Reddy’s talks about the challenges and solutions of maintaining supply during the pandemic.

Tim Wright, Editor, Contract Pharma 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 | Promotions & Moves

Jubilant Biosys Limited Appoints Giuliano Perfetti as CEO

Perfetti has more than 20 years of experience across diverse businesses and global markets.

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

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

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 | Facilities | Industry News | Regulatory Affairs

Sterling Pharma Solutions Recognized for Achievements in Sustainability

Awarded Gold Medal by EcoVadis.

09.03.21

Aseptic Processing | Breaking News | Industry News | Promotions & Moves

Roberto Almodóvar Febles Joins Pii as Head of Aseptic Operations

Will oversee and manage day-to-day aseptic manufacturing.

09.03.21

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

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

Aseptic Processing | Breaking News | cGMP Manufacture | Promotions & Moves

Pii Names Head of Aseptic Operations

Roberto Almodóvar Febles will oversee and manage day-to-day aseptic manufacturing.

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

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

EOC Pharma and Chime Biologics Extend Partnership

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

08.26.21

Analytical Services | Breaking News | Industry News | Laboratory Testing

Recipharm Strengthens Analytical Services Capabilities

CDMO launches new laboratory at its facility in Bengaluru, India to expand analytical services offering.

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 | Collaborations & Alliances | R&D

Roche, Shape Therapeutics Enter Strategic Gene Therapy Collaboration

ShapeTX will apply its RNA editing platform and leverage its AAVid technology platform for the development of gene therapy for various diseases.

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.

Breaking News | Industry News | Promotions & Moves

J&J CEO Alex Gorsky to Step Aside

Company will transition the CEO role to Joaquin Duato at the start of 2022.

08.23.21

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

Breaking News | Facilities | Industry News

Xellia’s Cleveland Manufacturing Facility is Commercially Operational

Site producing key anti-infective drug products for U.S. hospitals and patients.

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

APIs | Breaking News | Facilities | Industry News

Curia to Expand U.S. Commercial Manufacturing Capability

Roughly $35 million will be invested to expand manufacturing and product-handling solutions for complex small molecules.

08.19.21

Breaking News | Industry News | Promotions & Moves

Ashfield Health Appoints William Martino as Growth Director, North America

Martino has more than 20 years of leadership in healthcare marketing.

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

Breaking News

AltheaDx Expands Commercial Leadership Team

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

08.18.21

Breaking News | Information Technology

CSafe Global Appoints Ron Trainer as Director of Customer Service

Trainer has had an extensive career leading teams in the technology sector.

08.18.21

Breaking News | Industry News | Promotions & Moves

Lilly Forms Neuroscience and Immunology BUs

Makes executive leadership changes.

08.17.21

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

Breaking News | Industry News | Promotions & Moves

Altasciences Appoints Dr. Bruce Frank as VP, CDMO Operations

Frank will oversee the manufacturing, formulation and analytical teams.

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

Bora Names Sally Langa Global SVP Sales and Marketing

Langa is recognized throughout the industry for delivering diverse and profitable growth.

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 | 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

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

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.

APIs

Generic APIs Portfolio

With almost 50 years of expertise in peptide and small molecule synthesis, Bachem has an outstanding track record in large-scale manufacturing.

Breaking News | Industry News

Catalent, Edenbridge Pharma Enter Zydis Formulation Supply Agreement

Novel formulation of glycopyrrolate will use Catalent’s Zydis ODT delivery technology for adjunctive therapy for the treatment of peptic ulcer.

08.10.21

Breaking News | Promotions & Moves

Alcami Appoints Timothy Compton Chief Business Officer

Mr. Compton brings more than 25 years of industry experience leading high-performing business teams.

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

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 | Industry News | Promotions & Moves

Stelis Biopharma Appoints Mark Womack as CEO

Assumes the role of chief executive with immediate effect and will be stationed at Stelis HQ in Bengaluru, India.

08.06.21

Breaking News | Facilities | Industry News

TriRx Completes Acquisition of Elanco Animal Health Facility

Site in Shawnee, KS to become a global center of excellence serving the pharmaceutical contract development and manufacturing market.

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

Breaking News | Facilities | Industry News

Takeda Breaks Ground on New Manufacturing Facility

The $126 million investment increases the site’s capacity to manufacture additional products for the rare disease community.

08.05.21

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

Amgen Investing $550M in New Biomanufacturing Facility

Will create 355 new jobs at Holly Springs, NC site.

08.05.21

Breaking News | Financial Reports

Amgen's 2Q Results

Product sales up 3% in the quarter while earnings were impacted by $1.5 billion in acquired in-process R&D.

08.04.21

Breaking News | Facilities | Industry News

WuXi STA Completes Acquisition of BMS Manufacturing Facility

State-of-the-art facility in Couvet, Switzerland enhances WuXi STA's drug product capacity in Europe.

08.03.21

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

Breaking News | Financial Reports

Veklury Drives 2Q Growth for Gilead

Veklury (remdesivir) with sales of $829 million offsets loss of exclusivity of Truvada and Atripla in the U.S. with sales down 72% and 42%, respectively.

07.30.21

Financial Reports

AbbVie's 2Q Revenue up 34%

New immunology assets Skyrizi and Rinvoq contribute more than $1 billion of combined sales in the quarter.

07.30.21

Breaking News | Financial Reports

BMS 2Q Revenues up 16%

Top sellers Revlimid, Eliquis and Opdivo drive growth while established brands were down 64%.

07.30.21

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

Financial Reports

J&J's 2Q Pharma Sales Up 17%

STELARA and DARZALEX sales drive growth with sales up 34% to $2.3 billion and up 59% to $1.4 billion in the quarter, respectively.

07.29.21

Breaking News | Financial Reports

Pfizer's 2Q Revenues Up 92%

COVID-19 vaccine BNT162b2 contributes $7.8 billion in sales and alliance revenues.

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

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

Akston Biosciences, Seppic Ink Commercial Supply Agreement

Deal is for an adjuvant to formulate shelf-stable COVID-19 vaccine at global scale.

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 | Promotions & Moves

SCA Pharma Names Scott Luce as CEO

Luce’s priorities include serving new customer segments and fulfilling the company’s ambitious construction plan to expand capacity.

07.29.21

Breaking News | Industry News | Promotions & Moves

Sterling Pharma Solutions Appoints Ian Baxendale to Lead Dudley, UK Site

Baxendale has over 20 years of academic and industrial experience within organic synthesis.

07.29.21

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

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

Breaking News | R&D

Metrion Biosciences Appoints Nick Foster as Chief Commercial Officer

The appointment forms part of the company’s growth strategy for 2021 and 2022, with a focus on the USA, EU and Japan.

07.26.21

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 | 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

Breaking News | Industry News | Information Technology

Cognizant Agrees to Acquire TQS Integration

TQS’s data intelligence capabilities enhance Cognizant’s smart manufacturing offerings.

07.22.21

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

Reader Showcase

Aptar CSP’s Activ-Film Technology Protects COVID-19 Tests

Activ-Film technology protects two new at-home COVID-19 tests that recently received Emergency Use Authorization from the FDA.

07.21.21

Bioanalytical Services | Biologics, Proteins, Vaccines | Filtration & Purification | QA/QC | Reader Showcase

MOBILion Launches MOBIE HRIM for Biotherapeutic Drug Development

Designed to address characterization challenges during biopharmaceutical drug development and quality monitoring.

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

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

Reader Showcase | Serialization

Covectra Enhances ATLAS Serialization Platform for Repackaging

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

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

...

07.16.21

Biogen

...

07.16.21

Bayer

...

07.16.21

Teva

...

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

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

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

Cell & Gene Therapy Outsourcing Trends

Cell and gene therapies represent the next-generation of therapeutics.

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 | Collaborations & Alliances

Bicycle Therapeutics, Ionic Pharma Enter License & Collaboration Agreement

Will work together to develop targeted oligonucleotide therapeutics leveraging tissue-targeting TfR1 Bicycle 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

AMRI Becomes Curia

New brand reinforces ongoing expansion of expertise, capabilities and contributions to health care.

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

Breaking News | Industry News | QA/QC | Regulatory Affairs | Supply Chain

United States Pharmacopeia Acquires Pharmatech Associates

Expanded offerings will help regulated life science companies strengthen the supply chain for safe, quality medicines.

07.09.21

Nanotechnology & Medtech: A New Frontier

Three reasons why U.S. medtech companies go overseas for nanotechnology research.

Rachel Shelly, Head of Medical Technologies, IDA Ireland 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

APIs | Breaking News | GMPs/GCPs | Industry News | QA/QC

Purisys Obtains Two Global ISO Certifications

Now certified for ISO 17025 for Testing and Calibration Laboratories and ISO 17034 for Reference Material Producers.

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 | 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

Promotions & Moves

Valneva Appoints Ops SVP

Vincent Dequenne has an extensive track record in the pharmaceutical industry with more than 20 years of manufacturing and production experience.

07.07.21

VectorBuilder, Univercells Form Viral Vector Production Pact

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

07.06.21

V. Ashok Joins ACG as Group CFO

Ashok offers more than 30 years of global experience.

07.06.21

Recipharm to Build New Fill-Finish Facility in Morocco

Investment of around $500M by the Moroccan Government to establish capacity and capability for the manufacturing of vaccines and biotherapeutics.

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 | cGMP Manufacture | Drug Development | Industry News

Hermes Pharma Announces Spin-out from Hermes Arzneimittel

CDMO specializes in the development and manufacture of user-friendly oral dosage forms for healthcare companies around the world.

07.02.21

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

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

AGC Biologics to Acquire Novartis Facility in Longmont, CO

Significantly expands cell and gene therapy capabilities and offerings.

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

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

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

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

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

Analytical Services | Biologics, Proteins, Vaccines | Extractables and Leachables

On-Demand Lab Open House

Sign up to get a close-up look at our US network of laboratories and hear about our expansion plans.

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.

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

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

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 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

Breaking News | Facilities | Formulation Development | Industry News

Coriolis Pharma Expands ATMP Development Facilities

Construction of new facilities for ATMP formulation development up to biosafety level S2 are in progress and operations are expected to start by 4Q21.

06.21.21

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

Eisai, BMS Enter Global Anticancer ADC Alliance

BMS to pay as much as $2.45B to co-develop Eisai’s MORAb-202

06.18.21

Breaking News | Industry News | Laboratory Testing

Solvias Acquires Chemic Labs

Establishes U.S. lab presence and expands testing services.

06.18.21

APIs | Supply Chain

Maintaining Critical Drug Supply During the Pandemic

Vin Colicchio from Dr. Reddy’s talks about the challenges and solutions of maintaining supply during the pandemic.

Tim Wright, Editor, Contract Pharma 06.17.21

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

Breaking News | Facilities | Industry News | Lyophilization

Horizon Therapeutics Buys EirGen Manufacturing Facility

The 44,000 square foot facility in Ireland includes fill-finish and analytical laboratory capabilities with potential for site expansion.

06.17.21

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

Sanofi Invests $425M in Flu Vaccine Manufacturing Facility

Newly licensed U.S. manufacturing facility to increase availability of Fluzone High-Dose Quadrivalent.

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 | 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

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

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

BD Hits 2 Billion Injection Device Milestone for COVID-19 Vaccinations

Company now supplying more than 40 countries for pandemic vaccination campaigns.

06.11.21

Enteris BioPharma Receives $10M Milestone from Cara Therapeutics

Third milestone payment related to the development of Oral KORSUVA.

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

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.

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

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

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

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

Bioanalytical Services | Bioassay Development | Biologics, Proteins, Vaccines

The Future of Continuous Bioprocessing

The modernization of advanced therapy manufacturing.

Dr. Karoline Hahn, Senior Consultant for Advanced Therapies, KCR 06.02.21

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

Moderna, Thermo Fisher Enter COVID Vax Fill/Finish Mfg. Pact

Thermo will provide aseptic fill/finish, labeling and packaging from its commercial manufacturing site in Greenville, NC.

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 | Industry News

Thibault Jonckheere Named CEO of Exothera

The viral vector CDMO spinoff of Univercells is making an intranasal vaccine candidate for Covid-19 treatment.

Tim Wright, Editor, Contract Pharma 06.01.21

Samsung Biologics Expands Vaccine Manufacturing Capabilities

To add mRNA vaccine drug substance manufacturing suite to expand portfolio of services.

Tim Wright, Editor, Contract Pharma 06.01.21

Bioanalytical Services | Biologics, Proteins, Vaccines

The Future of Continuous Bioprocessing

The Modernization of Advanced Therapy Manufacturing

Dr. Karoline Hahn, Senior Consultant for Advanced Therapies, KCR 05.27.21

Bio News | Breaking News | Industry News

August Bioservices Expands U.S. Biopharma Manufacturing Capabilities

$23.6 million investment from Polaris Partners will expand manufacturing capacity and capabilities to support production of sterile injectables.

Tim Wright, Editor, Contract Pharma 05.27.21

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

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 | Industry News | Injectables

Stevanato Group, Corning Partner on Solution for Injectable Drugs

New product, Corning Valor RTU Vials with SG EZ-fill Technology, offers a unique combination of Corning Valor Glass vial attributes with SG EZ-fill integration.

Kristin Brooks 05.26.21

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 | 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

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 | Drug Development | Industry News

Xeris to Acquire Strongbridge Biopharma

The two businesses will be combined under a new entity called Xeris Biopharma Holdings, specializing in endocrinology and rare diseases.

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 | 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

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

Information Technology

Navigating the Digital Transformation Journey

Uncover the real impact of “digital transformation” in this white paper, packed with practical advice to help you plan your own transformative journey.

Breaking News | Promotions & Moves

BioNTech SE Appoints Jens Holstein as CFO

Holstein succeeds Dr. Sierk Poetting.

Charles Sternberg, Assistant Editor 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

Breaking News | Industry News | Logistics | Packaging & Tracking

Woodfield Distribution, Bonne Santé Form 3PL Partnership

Agreement calls for the implementation of a comprehensive logistics program for Bonne Santé companies and products.

Tim Wright, Editor, Contract Pharma 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

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

WuXi Biologics, WuXi STA Establish WuXi XDC JV

To provide contract development and manufacturing of bioconjugates including antibody-drug conjugates (ADCs).

Kristin Brooks 05.14.21

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 | 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 | 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 | 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

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 | Collaborations & Alliances | Industry News | Packaging & Tracking | Serialization

Yangtze River Pharmaceutical Group Selects TraceLink Solution to Aid Growth

Will use TraceLink’s applications and digital supply network to comply with track and trace requirements in multiple markets.

Charles Sternberg, Assistant Editor 05.07.21

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

Catalent Acquires Commercial-Scale Plasmid DNA Mfg. Facility

Promethera’s Hepatic Cell Therapy Support SA include's 32,400 sq.-ft. facility in Gosselies, Belgium.

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

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 Changing Nature of Communications

Is Zoom burnout leading to a resurgence of the “good-ol” phone call?

David G. Jensen, Contributing Editor 05.05.21

Ensuring Pharma Manufacturing Quality

How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.

Shahid Manzur, Principal, EY 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

Financial Reports

Pfizer 1Q Revenues up 45% Driven by COVID Vax

Vaccine sales were $4.9 billion in the quarter, with BNT162b2 contributing $3.5 billion in global revenues.

Kristin Brooks 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

Are Your Suppliers Supporting Your Growth?

The role of strategic sourcing and procurement for emerging biopharmaceutical companies.

Dave Stowe and Jonathan Horn, Tunnell Consulting 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

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

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

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Fill/Finish | Industry News

Sanofi, Moderna Enter COVID-19 Vaccine Fill/Finish Manufacturing Deal

Sanofi will provide fill/finish services for up to 200 million doses of Moderna’s COVID-19 vaccine in the U.S. beginning in September 2021.

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

Breaking News | Financial Reports

Gilead Revenues up 16% in the Quarter

Veklury drives growth in the quarter, offsetting significant declines in HIV, HCV franchises.

Kristin Brooks 04.30.21

Breaking News | Financial Reports

Abbvie's 1Q Reveneus up 51%

Aesthetics portfolio drives growth in the quarter with Botox Cosmetic sales up 45%.

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 | 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

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 | 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

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 | Collaborations & Alliances

Bushu, Suzuken Collaboration Expands Services for Specialty Pharmaceuticals

Establishment of new business alliance and facility to provide support for new product launches for manufacturers aiming to enter Japan market.

Tim Wright, Editor, Contract Pharma 04.27.21

Breaking News | Collaborations & Alliances | Industry News

Elektrofi, Argenx Enter Collaboration and License Agreement

Will explore new subcutaneous formulations for therapeutic products directed at the human neonatal Fc receptor.

Charles Sternberg, Assistant Editor 04.27.21

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 | 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

Breaking News | Drug Development | Drug Discovery

KemPharm Receives $10M Milestone for FDA Approval of Azstarys

Is eligible to receive an additional near-term $10 million milestone payment following DEA scheduling of SDX.

Charles Sternberg, Assistant Editor 04.22.21

Breaking News | Promotions & Moves

CSafe Global Appoints SVP of Technology and Innovation

Welcomes Venu Vinjamaram to the company’s senior leadership team.

Charles Sternberg, Assistant Editor 04.22.21

Bio News | Bioanalytical Services | Breaking News | Industry News

Waters and Genovis Enter Biopharmaceutical Partnership

Collaboration intended to bring speed and simplicity to bio-characterization workflows.

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

TraceLink Introduces Opus Platform

Enables industries to work together with collective intelligence.

Charles Sternberg, Assistant Editor 04.21.21

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

Evotec to Build Second Biologics Mfg. Facility in Toulouse

Evotec's first commercial biomanufacturing facility in Europe is anticipated to deliver much needed capacity for biotherapeutic development and manufacturing.

Kristin Brooks 04.20.21

Breaking News | Financial Reports

Johnson & Johnson 1Q Results

Pharmaceutical sales up 10% in the quarter driven by DARZALEX, STELARA, INVEGA SUSTENNA, and IMBRUVICA.

Kristin Brooks 04.20.21

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

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

Pfizer, BioNTech Expand COVID-19 Vaccine Agreement with EU

EU orders 100 million additional doses of COMIRNATY, bringing total doses to 600 million for 27 EU member states.

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

Biologics, Proteins, Vaccines | Breaking News | Industry News | Information Technology

ATMPS, Ori Biotech Integrate Digital Platform for Cell & Gene Therapies

Aims to provide improved product tracking, scheduling and live monitoring of the manufacturing status across the entire CGT supply chain from vein to vein.

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

Albumedix Completes Commercial-Scale Mfg. Facility Expansion

Will service increasing demand for products and technologies for cell and gene therapies, vaccines, diagnostics, protein and peptide therapeutics.

Kristin Brooks 04.14.21

cGMP Manufacture | QA/QC

Ensuring Pharma Manufacturing Quality

How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.

Kristin Brooks, Contract Pharma 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

Vetio Expands Jupiter, FL Site

Adds new manufacturing plant, customized R&D labs for liquids and solid dosage supplements, and additional warehousing.

Charles Sternberg, Assistant Editor 04.13.21

Breaking News

Woodstock Sterile Solutions Appoints CCO

Bill Hartzel will report to Woodstock CEO Paul Josephs.

Charles Sternberg, Assistant Editor 04.13.21

Breaking News | Promotions & Moves

AGC Biologics Appoints Jun Takami GM of Chiba Site

Mr. Takami brings more than 15 years of experience in the pharmaceutical industry.

Kristin Brooks 04.08.21

Breaking News | Promotions & Moves

Imvax Appoints Sean Hemingway Chief Operating Officer

Hemingway brings more than 25 years of experience in biological manufacturing and supply chain.

Kristin Brooks 04.08.21

Breaking News | Industry News | Promotions & Moves

Legacy Pharma Solutions Appoints President

Promotes Brad Rayner, a 17-year executive of the pharmaceutical industry.

Charles Sternberg, Assistant Editor 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 | 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

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

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 | Promotions & Moves

Formulated Solutions Appoints Ray Bodamer Ops VP

Will focus on optimizing the performance of commercial filling, packaging, maintenance and process improvement engineering.

Kristin Brooks 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

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.

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

Aseptic Processing | Breaking News | Collaborations & Alliances | Industry News

Steriline Delivers New Manufacturing Line to Bess Pro

Provided a turnkey line, fully operating and ready to perform at full capacity.

Charles Sternberg, Assistant Editor 03.31.21

Breaking News | Industry News | Promotions & Moves

Vibalogics Updates U.S. Leadership Team

Appoints new CFO, VP of quality and head of process sciences.

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

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

CureVac, Celonic Enter COVID-19 Vax Mfg. Pact

Celonic is prepared to manufacture more than 100 million doses of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV, per year at Heidelberg facility.

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

Jubilant, Novavax Enter COVID-19 Vaccine Partnership

Jubilant to provide fill-finish manufacturing services for the production of COVID-19 vaccine candidate NVX-CoV2373.

Tim Wright, Editor, Contract Pharma 03.29.21

APIs | Breaking News | Custom Sourcing News

Asymchem Expands Oligonucleotides Mfg. Capacity

API facility in Tianjin, China will accommodate gram to ton production scales with capacity to accommodate 12 or more oligo process production lines.

Kristin Brooks 03.26.21

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

Breaking News | Industry News | Information Technology | Promotions & Moves

LabVantage Solutions Names Mikael Hagstroem as CEO

Brings almost 30 years of experience as a pioneer and expert in digital transformation.

Tim Wright, Editor, Contract Pharma 03.25.21

Breaking News | cGMP Manufacture | Collaborations & Alliances

BioCentriq, Kytopen Enter Cell Therapy Alliance

Demonstrates the impact of transformative technology on cell therapy manufacturing.

Charles Sternberg, Assistant Editor 03.24.21

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

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

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

BioCentriq and Kytopen Enter Cell Therapy Partnership

To show the impact to autologous and allogeneic cell therapies by integrating novel transfection technology with other steps in the manufacturing process.

Tim Wright, Editor, Contract Pharma 03.23.21

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

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

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

Fujifilm Selects North Carolina for $2B Bio CDMO Facility

Holly Springs is the location chosen to build the largest cell culture biopharmaceutical CDMO facility in North America.

Tim Wright, Editor, Contract Pharma 03.19.21

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

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.

Advancing Biopharma, R&D Innovation, Decision Making & Operations

...

03.17.21

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

Catalent Expands Partnership with J&J

To significantly increase capacity for sterile manufacturing and packaging of COVID-19 vaccine in Italy.

Tim Wright, Editor, Contract Pharma 03.17.21

Breaking News | Facilities | Industry News | Logistics | Packaging & Tracking

WDSRX Establishes National 3PL Presence

Opens Reno, NV and San Antonio, TX pharmaceutical warehouses.

Tim Wright, Editor, Contract Pharma 03.17.21

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

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

Northwest Biotherapeutics Adds Production Capacity at UK Facility

Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.

Kristin Brooks 03.16.21

Breaking News | Promotions & Moves

Univercells Technologies Names CEO

Mathias Garny to lead the growth and commercialization strategy for biomanufacturing product portfolio and new technology developments.

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

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 | Industry News

Generic Version of Symbicort Granted FDA Approval

Product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).

Charles Sternberg, Assistant Editor 03.09.21

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

High Purity New England & Univercells Technologies Unveil Bioprocessing Solutions

New highly scalable line of bioreactors designed to ensure seamless scalability from early process development to commercial manufacturing.

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 | cGMP Manufacture | Industry News | Inspections

Metrics Contract Services Completes Russian Regulatory Inspection

Greenville, NC site approved to make an oncology drug to be marketed in Russia.

Tim Wright, Editor, Contract Pharma 03.09.21

Baxter Biopharma Enters Sterile Manufacturing Agreement for Novavax’ COVID-19 Vaccine

Manufacturing to take place at Baxter’s state-of-the-art Halle/Westfalen, Germany facility.

Tim Wright, Editor, Contract Pharma 03.09.21

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

Breaking News | cGMP Manufacture | Drug Development | Industry News

Vetter Establishes Office in China

Additional office in Asia Pacific region to promote development of new business in China.

Kristin Brooks 03.08.21

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

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

Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie

Continues to build integrated capabilities platform for cell and gene therapy.

Tim Wright, Editor, Contract Pharma 03.05.21

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

Fujifilm Breaks Ground on Major Expansion of Biologics Facility in Denmark

Virtual ground-breaking ceremony celebrates initiation of expansion to double cell culture capacity and add large scale fill/finish capabilities.

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 | Industry News

Amgen to Acquire Five Prime Therapeutics for $1.9B

Adds Five Prime's pipeline of immuno-oncology and targeted cancer therapies to Amgen's oncology portfolio.

Kristin Brooks 03.04.21

Combination Products & The CDMO Webinar - Watch Now On-Demand

During this webinar, regulatory and quality experts from Alcami provided insights into combination products and the latest regulatory guidance.

Breaking News

Fusion Pharmaceuticals Acquires IPN-1087

Expands its pipeline of potent alpha-emitting radiopharmaceuticals.

Charles Sternberg, Assistant Editor 03.02.21

Breaking News | Industry News

Q BioMed Inks Strontium89 Supply Pact

Agreement provides U.S. veterans and other federal government agencies access to Strontium89 for metastatic bone pain.

Kristin Brooks 03.02.21

Information Technology

5 Reasons Paper Has No Place in Contract Manufacturing

Digital solutions create more efficient manufacturing processes and eliminate delays.

Dave Edwards, Chief Revenue Officer, MasterControl 03.01.21

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

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

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

Thermo Fisher Scientific Completes Mesa Biotech Acquisition

Becomes part of the Life Sciences Solution Segment and is expected to add revenue of approximately $200 million in 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

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

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

Catalent Acquires Delphi Genetics

Launches US plasmid manufacturing site to establish global pDNA development and manufacturing capabilities.

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

APIs | Breaking News | Formulation Development | Industry News

Tris Pharma, Athena Bioscience Enter Exclusive License Agreement

Athena gains exclusive rights to commercialize a long-acting antihypertensive product developed using Tris' proprietary technology.

Kristin Brooks 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

Drug Development

Embedding Your Drug Strategy Within a Solid Foundation for Success

This whitepaper looks at the broad set of trends inﬂuencing pharmaceutical development and manufacturing strategy today.

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

RedHill and Cosmo Strengthen Manufacturing Agreements

Secures manufacturing capacity of Movantik for opioid-induced constipation and RHB-204, currently in a Phase 3 study for pulmonary NTM disease.

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

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

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

Breaking News | Promotions & Moves

Executive Moves at Frontage

Represents the next step in the ongoing expansion of Frontage Laboratories to a global platform with increased presence in key markets.

Kristin Brooks 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

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 | Industry News | Promotions & Moves

CDMO Recro Strengthens Leadership Team

Names CDMO industry thought leader Jim Miller to board and selects Ryan Lake as CFO.

Tim Wright, Editor, Contract Pharma 02.12.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Evonik Strengthens Partnership with BioNTech on COVID-19 Vaccine

Establishment of additional lipid production in Germany for use with mRNA-based vaccines.

Tim Wright, Editor, Contract Pharma 02.12.21

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

Molecular Templates, BMS Enter Strategic Research Pact

Aims to discover and develop multiple therapies for specific oncology targets utilizing MTEM’s next-gen engineered toxin body (ETB) platform.

Kristin Brooks 02.11.21

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

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

Jubilant Biosys, Yale Form Research Alliance

Aims to accelerate small molecule discovery programs leveraging Jubilant's medicinal chemistry, structural biology, in-vitro and in-vivo pharmacology.

02.10.21

Financial Reports

Pfizer's 4Q Revenues up 12%

COVID-19 vaccine BNT162b2, which was granted an EUA in the U.S. in December 2020, contributed $154 million in sales in the quarter.

Kristin Brooks 02.09.21

Financial Reports

Gilead 4Q Revenues up 26%

Revenue growth for the quarter and full year was primarily due to the launch of Veklury (remdesivir).

Kristin Brooks 02.09.21

Promotions & Moves

Lilly Apoints SVP, CFO

Anat Ashkenazi replaces Josh Smiley, who has resigned and will be leaving the company.

Kristin Brooks 02.09.21

Promotions & Moves

BioDuro-Sundia Appoints CEO

Haijun Dong to lead the company into the next phase of growth as a leading CRDMO in the industry.

Kristin Brooks 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 | 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 | Collaborations & Alliances | Industry News

Recipharm and Medspray Complete Joint Venture

Aim to utilize novel softmist technology for pharmaceutical applications.

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

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

Breaking News | Financial Reports

Regeneron 4Q and FY20 Results

REGEN-COV antibody cocktail for COVID-19 received FDA EUA; Net sales of REGEN-COV were $146 million in the quarter and $186 million for the year.

Kristin Brooks 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

Financial Reports

Financial Report: Roche

Newly launched medicines Tecentriq, Hemlibra, Ocrevus, Perjeta and Kadcyla offset the impact of competition from biosimilars for established medicines.

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

Breaking News | cGMP Manufacture

CSafe Global Expands in Asia

Opens two new hub operations in Beijing and Guangzhou, China.

Charles Sternberg, Assistant Editor 02.03.21

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

Breaking News | Drug Delivery | Industry News

Recipharm, Medspray Launch Resyca JV

To develop and exploit the softmist spray nozzle technology for pharmaceutical applications.

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

Novartis Inks Contract Manufacturing Deal for Pfizer-BioNTech COVID-19 Vaccine

Novartis to leverage manufacturing capacity and capabilities to address pandemic, supporting global supply of COVID-19 vaccine.

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

Evozyne, Takeda Ink Strategic Protein Design Agreement

Takeda will use Evozyne's evolution-based protein design technology to research and develop proteins for next-gen gene therapies.

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

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

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

21st Annual Contracting & Outsourcing Conference & Exhibition

...

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 | Facilities | Industry News | Injectables | Parenterals

Civica to Build an Essential Medicines Manufacturing Facility in Virginia

Will produce sterile injectable meds used in hospitals for COVID-19 patient care.

Tim Wright, Editor, Contract Pharma 01.25.21

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 | Promotions & Moves

AGC Biologics Appoints Boulder Site GM

David Stewart to oversee the startup, strategic development and operational excellence in large-scale biologics production at the Boulder, CO site.

Kristin Brooks 01.22.21

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

AbbVie Licenses ProBioGen’s GlymaxX Technology

Will apply GlymaxX technology to boost the antibody-dependent cell-mediated cytotoxicity (ADCC).

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 | Industry News | Information Technology | Validation

Global Biosciences Co. Selects ValGenesis VLMS

Will digitize the validation service activities for efficient and faster access to validated and safer products across 40 countries.

Contract Pharma Staff 01.20.21

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

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

Promotions & Moves

Valeo Pharma Appoints President, COO

Frederic Fasano brings 25 years of experience to the newly created position.

Contract Pharma Staff 01.18.21

Biologics and Manufacturing

Syngene offers Biologics development and Biomanufacturing solutions in both mammalian and microbial systems.

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

APIs | Breaking News | Facilities | Industry News

Sanofi Unveils EUROAPI as Name of New European API Company

Appoints Karl Rotthier as its future Chief Executive Officer.

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

Breaking News | Collaborations & Alliances

Charles River Partners with JADE

Expands its biologics testing capabilities geographically and helps to accommodate demand for biologics therapeutics.

Contract Pharma Staff 01.14.21

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

Fujifilm, CABIM Get $76M Funding for Mfg. and Innovation Center

FUJIFILM Diosynth Biotechnologies will provide GMP contract process development and manufacturing services as part of its role in the new center.

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

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

Breaking News | Collaborations & Alliances | Drug Discovery | Industry News | R&D

Almac Sciences Secures Support from Invest NI

Accelerates enzyme discovery program.

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

Commercial Manufacturing

Syngene supports manufacturing of regulatory starting materials, APIs, HPAPI, NCEs and novel advanced intermediates.

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 | Drug Delivery | Industry News

iosBio Inks Exclusive Vax Platform Pact for COVID-19

OraPro oral delivery vaccine platform technology enables oral administration of thermally-stable, viral vector vaccines.

Contract Pharma Staff 01.12.21

Drug Product Development, Manufacturing, and Packaging

Parenteral Forms.

Baxter, Novavax Ink Sterile Manufacturing Agreement

CMO Baxter will help increase commercial production and promote access to Novavax' Covid-19 vax in UK and European markets.

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

ICH Stability Studies

One of the largest Stability facilities in Asia, Syngene supports both small and large molecules from early development to CMC filing and commercialization.

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

Alcami Expands Oral Solid Capabilities with Investment in Wilmington, NC

...

Biologics, Proteins, Vaccines | Breaking News | Industry News

Botanical Solution Inc. to Supply Pharma Grade QS-21 Vaccine Adjuvant

Secures $3.3 million in funding with second round planned for Spring 2021 to bolster growth.

Contract Pharma Staff 01.06.21

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

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

Analytical Services | Biologics, Proteins, Vaccines | Clinical Trial Materials | Laboratory Testing

Samsung Biologics Continues to Leverage Digitalization to Optimize Client Experience

Through digital transformation, Samsung Biologics is innovating how they connect with clients, regulatory bodies and industry professionals.

Breaking News | cGMP Manufacture

Ajinomoto Bio-Pharma and Revance Therapeutics Partner

Sign manufacturing agreement for supply of DaxibotulinumtoxinA for injection.

Contract Pharma Staff 12.22.20

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

Abenza Promotes Kimball Hall to President

Hall also joins the Company Board.

Contract Pharma Staff 12.18.20

Breaking News | Packaging & Tracking

Aptar CSP Increases Capacity for Active Packaging Solutions

3-Phase Activ-Polymer platform technology protects electrochemical, lateral flow, and molecular diagnostic test kits.

Contract Pharma Staff 12.17.20

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

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

Evotec, BMS Advance Targeted Protein Degradation Projects

The first two targets transition into drug discovery after completing a comprehensive target validation process.

Contract Pharma Staff 12.17.20

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

Samsung Biologics Names John Rim as President and CEO

Prior to being named chief executive, Rim was executive vice president at the Korea-based CDMO for the past three years.

Contract Pharma Staff 12.16.20

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

Got Floor Space? – Increase Workspace Efficiency

By JULIE MENO, Strategic Initiatives Manager, FEDERAL EQUIPMENT COMPANY

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

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

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 | 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

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

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

Thermo Fisher Scientific Further Expands Global Footprint

Will expand sites in Greenville, NC; Swindon, UK; and Ferentino and Monza, Italy for sterile drug product development and commercial manufacturing.

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

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 | 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 | Industry News

HALIX, AstraZeneca Ink Commercial COVID-19 Vax Mfg. Pact

HALIX to provide large-scale GMP manufacture of AZD1222 at its cGMP facility in the Netherlands.

Contract Pharma Staff 12.08.20

Breaking News | Facilities | Industry News

Bora Establishes First HQ in North America

Chooses Mississauga for its flagship North American manufacturing facility.

Contract Pharma Staff 12.07.20

Facilities

Reed-Lane Adds Second Track & Trace Cartoning Line

Adds aggregation capabilities and expands injectables kitting operations.

Contract Pharma Staff 12.04.20

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

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 | Promotions & Moves

Frontida BioPharm Appoints Chief Financial Officer

Puneet Sapra brings 20 years of pharmaceutical and healthcare experience in executive roles at Pfizer, Johnson & Johnson, and Halma.

Contract Pharma Staff 12.02.20

Cold Chain Management | Industry News | Logistics | Reader Showcase | Vials

Reflect Scientific’s Cryometrix Suitable for COVID-19 Vax Air Transport

Large shipping system capable of carrying thousands of doses of vaccines that may require temperatures as low as -80° C using liquid nitrogen technology.

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

Bormioli Pharma Acquires ISO GmbH

Broadens its range of packaging for parenteral drugs.

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

Recipharm Inks Covid-19 Vax Pact with Moderna

Signs of letter of intent for aseptic fill-finish manufacturing of Moderna’s COVID-19 vaccine candidate (mRNA-1273).

Contract Pharma Staff 12.01.20

Breaking News | Drug Development | Formulation Development | Industry News

Vectura, Kinaset Partner to Develop Asthma Treatment

Licenses VR588 to Kinaset, Vectura will provide formulation development services to support Phase I studies and ultimately commercialization.

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

...

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

Breaking News | Facilities | Industry News | Injectables | Parenterals

ApiJect Systems Approved for $590 Million Loan

Supports building a U.S.-based facility with surge capacity to produce up to 3 billion single-dose prefilled plastic injectors per year.

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 | Facilities | Industry News

Abenza Upgrades Chemistry GMP Suites

Appoints new leadership at Bristol PA site.

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

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

AstraZeneca’s AZD1222 Meets Primary Endpoint in COVID-19

Two different dosing regimens demonstrated efficacy with one showing vaccine efficacy of 90% with no serious safety events noted.

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 | cGMP Manufacture | Industry News

Catalent, Blueprint Enter GAVRETO Commercial Supply Pact

Following FDA approval and tech transfer, the Catalent team in Kansas City will support commercial supply of the non-small cell lung cancer drug.

Contract Pharma Staff 11.23.20

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

Biologics, Proteins, Vaccines | cGMP Manufacture

Delpharm to Manufacture Pfizer/BioNTech mRNA Vax in France

Will begin manufacturing BNT 162b2 in April 2021 and will produce tens of millions of doses.

Contract Pharma Staff 11.19.20

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

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

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

Excipients

Bye-Bye China?

Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.

Michele Jermini and Enrico Polastro 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

Drug Delivery | Industry News

Recipharm, Medspray Establish JV

To exploit novel softmist technology for pharmaceutical applications.

Contract Pharma Staff 11.17.20

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

Information Technology | Supply Chain

The Pandemic & The Pharma Industry: 3 Things to Know

The importance of vendor contract visibility, an increase in intense legal scrutiny, and new technology for greater agility and control.

Colin Earl, CTO at Agiloft 11.16.20

APIs | Breaking News | Facilities | Industry News

Onyx Scientific Invests in New Facility

Prepares for the approval of a commercial API license.

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

Breaking News | Facilities | Industry News

Eisai Invests in New Packaging Lines

Expands Hatfield production plant in Hertfordshire.

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

Preparing to Adopt Intelligent Label Management

The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.

Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA 11.13.20

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

CCRM, MIP Partner to Build Biomanufacturing Campus

Aims to establish CDMO ops focused on regenerative medicine-based technologies and cell and gene therapies.

Contract Pharma Staff 11.13.20

Breaking News | Logistics | Packaging & Tracking | Supply Chain

Antares Vision Acquires Adents Traceability Assets

Expands portfolio of software solutions and cloud services for end-to-end traceability.

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

Breaking News | Industry News | Promotions & Moves

Cytovance Appoints CEO

Bin Zhang has been with Cytovance as a member of the Board of Directors since 2018.

Contract Pharma Staff 11.12.20

Breaking News | CRO News | Facilities | Industry News

Evotec SE Expands UK Campus

Adds new building, which will house up to 100 biologists by the end of the year.

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

...

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 | Cold Chain Management | Fill/Finish | Industry News | Vials

Aphena Adds Cold Chain Storage, Biologics Packaging and Distribution

Expansion includes 14,000 cold chain pallet spaces in new 500K-sq.-ft. facility.

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

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

CEVEC, Roche Ink ELEVECTA Technology License Agreement

Allows Roche to use CEVEC's ELEVECT Technology for AAV vector manufacturing for its portfolio of gene therapy products.

Contract Pharma Staff 11.11.20

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

Novavax Expands Facility to Support Global Vaccine Development

Expands campus with two properties to support vaccine research and development, manufacturing, business operations.

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

Gilead Bolsters Biologics Capabilities

Licenses ProteoNic’s 2G UNic Technology Platform for production of biologics.

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 | Collaborations & Alliances | Industry News

AMRI Named Exclusive API Supplier for Recently Approved Acne Treatment

FDA approved Cassiopea’ Winlevi cream 1% in August 2020.

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

Breaking News | Industry News | Logistics

Legacy Pharmaceutical Packaging Adds Facility for 3PL Ops

Total footprint now exceeds 500,000 sq.-ft.

Contract Pharma Staff 11.06.20

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

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

Jubilant Radiopharma, SOFIE Biosciences Ink Strategic Pact

Jubilant will be a strategic partner to SOFIE enabling SOFIE to expand production capacity and advance its theranostic pipeline.

Contract Pharma Staff 11.04.20

Financial Reports

Financial Report: Amgen

Revenues up 12% in the quarter to $6.4 billion.

Contract Pharma Staff 11.04.20

Financial Reports

Financial Report: Novartis

Pharmaceutical sales up 2% driven by Entresto, Cosentyx and Zolgensma.

Contract Pharma Staff 11.04.20

Financial Reports

Financial Report: Pfizer

Revenues down 4% in the quarter to $12.1 billion.

Contract Pharma Staff 11.04.20

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

Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs

...

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

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

Financial Reports

Financial Report: Abbvie

Revenue up 52% in the quarter to $12.9 billion.

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

Bio News | Breaking News | Drug Development | Facilities | Industry News

Samsung Biologics Expands Global Footprint

Opens new San Francisco CDO R&D Center.

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

Breaking News | Laboratory Testing | Promotions & Moves

Avomeen Names SVP of Lab Operations

Luke Miller brings 25 years of experience to the company.

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 | Financial Reports

Financial Report: Gilead

Veklury (remdesivir) revenues were $873 million in the third quarter.

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

Breaking News | cGMP Manufacture | Industry News

Aphena Pharma Completes $7M Facility Expansion

Newly renovated, 30,000-sq.-ft. facility and three large blending suites support liquids, creams, gels and suspensions.

Cntract Pharma Staff 10.28.20

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

MolMed S.p.A Becomes AGC Biologics S.p.A

AGC Biologics now provides end-to-end cell and gene therapy CDMO services.

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 | 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 | Financial Reports

Financial Report: Lilly

Revenue up 5% in the quarter to $5.7 billion.

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

Financial Reports

Financial Report: Biogen

Revenues down 6% in the quarter to $3.4 billion.

Contract Pharma Staff 10.26.20

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

Breaking News | Industry News | Packaging & Tracking | Serialization

TraceLink Launches Serialized Product Intelligence Solution

Allows companies to proactively monitor their serialized operations and gain actionable insights to avoid costly delays and ensure product availability.

Contract Pharma Staff 10.21.20

Breaking News | Collaborations & Alliances | Industry News

Lubrizol Expands Partnership with the Population Council

Will develop a contraceptive vaginal system for protection against unintended pregnancy.

Contract Pharma Staff 10.21.20

Bio News | Breaking News | Facilities | Industry News

Roche Canada to Invest $500M to Create 500 Jobs in Ontario

City of Mississauga applauds Roche Canada jobs investment in Life Sciences Industry.

Contract Pharma Staff 10.21.20

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

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 | Collaborations & Alliances

Cytocom and Cleveland Biolabs Merge

Combine their businesses in an all-stock transaction.

Contract Pharma Staff 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

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

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

Antegene, WuXi Biologics Enter Oncology R&D Alliance

To collaborate on the development and production of novel drugs, and jointly promote the R&D of innovative oncology therapies in China.

Contract Pharma Staff 10.19.20

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

BioLife Solutions Secures $2.7 Million Contract

Will provide cold chain management and storage of COVID-19 vaccines.

Contract Pharma Staff 10.19.20

Breaking News | Financial Reports

Financial Report: Johnson & Johnson

Pharmaceutical sales were up 5% in the quarter to $11.4 billion.

Contract Pharma Staff 10.16.20

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

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

GSK to Sell Poznań Manufacturing Site to Delpharm

The CDMO acquires all facilities and gains approximately 700 manufacturing employees.

Contract Pharma Staff 10.15.20

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

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

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

Pelican BioThermal Opens Strasbourg Service Center

Provides support services for Crēdo Cube reusable shippers.

Contract Pharma Staff 10.14.20

Breaking News | Industry News | Vials

Momentive, Stevanato Partner to Offer Vial Packaging Solution

To supply Pur Q fused quartz vials in EZ-fill packaging format to help streamline fill-finish operations for early phase drug development.

Contract Pharma Staff 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

Biologics, Proteins, Vaccines | Breaking News | Industry News

MilliporeSigma Launches VirusExpress Platform

Scalable platform increases dose yields and reduces process development time for cell and gene therapies.

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

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

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 | 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

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

Bioanalytical Services | Breaking News | cGMP Manufacture | Industry News

FDA Approves First Drug Using AJIPHASE Production Process

AJIPHASE platform is for the development and cGMP manufacture of high quality and purity commercial quantities of oligonucleotides and peptides.

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

Breaking News | Promotions & Moves

Abenza Appoints SVP and Site Head

Giovanni Escobar brings over 27 years’ experience in the Pharmaceutical industry.

Contract Pharma Staff 10.06.20

Breaking News | Promotions & Moves

Tergus Pharma Expands Executive Leadership

Appoints VP of quality and VP of manufacturing.

Contract Pharma Staff 10.06.20

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

Zenith Technologies Collaborates with Ideagen

Adopts Ideagen’s Q-Pulse eQMS software to improve performance visibility.

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 | Promotions & Moves

3P Expands Management Team

Adds José Luis Bartolomé as operational excellence and continuous improvement director.

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 | 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

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

APIs | Breaking News | cGMP Manufacture | Industry News

BIAL, Recipharm Expand Long-Term API Supply Pact

Expanded agreement follows approval and launch of Opicapone in Japan to treat Parkinson’s.

Contract Pharma Staff 10.01.20

Bio News | Breaking News | Facilities | Industry News

Arranta Bio Establishes Commercial-Ready Manufacturing Facility

Enables the CDMO to supply vital products to patients in need.

Contract Pharma Staff 09.28.20

Promotions & Moves

ERS Genomics Appoints IP & Commercial Development VP

Michael Arciero will oversee the intellectual property portfolio of the company and will become a core member of the global business development team.

Contract Pharma Staff 09.23.20

Clinical Trials | Drug Development

How to Balance Internal and External Staff Within Outsourcing Models

Strategies to consider in flexed staffing models.

John Barry, SVP, Consulting Practice and Chief Strategy Officer, PRA Health Sciences, SSD 09.22.20

Breaking News | Promotions & Moves

Luminer Appoints Sales Executive

Mike Barrett’s responsibilities include driving growth in Luminer’s legacy, as well as a brand-broadening expansion into new niches.

Contract Pharma Staff 09.11.20

Capsules | Solid Dosage/Creams/Ointments

Beyond the Boundaries

New capsule types resolve emerging formulation needs.

Sven Stegemann, ACG Capsules 09.09.20

Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs

Expediting a COVID-19 Vaccine: FDA Approval Process

The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.

Kristin Brooks, Managing Editor 09.09.20

Breaking News | Promotions & Moves

Camargo Appoints Commercial Strategy VP

Rob Lawrence will lead the design and development of strategic solutions that aim to optimize patient access and outcomes.

Contract Pharma Staff 08.31.20

Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs

Expediting a COVID-19 Vaccine: FDA Approval Process

The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.

Kristin Brooks, Contract Pharma 08.25.20

Biopharmaceutical Manufacturing under Regulatory Compliance: Process Strategies, CGMP Considerations

...

08.20.20

Clinical Trials | Drug Development

Pharma’s Imperative: Rethinking the FSP Outsourcing Paradigm

Evaluating outsourcing strategies amid a complex trial landscape to further enhance clinical operations.

Michael D. Jones , Vice President of Clinical FSP Client Engagement, IQVIA 08.17.20

Breaking News | Collaborations & Alliances | Industry News

Avid Selected to Lead Process Development of IOV-3001

Will provide process development, pilot-batch manufacturing & CGMP manufacturing services for Iovance Biotherapeutics.

Contract Pharma Staff 08.06.20

Commercial Manufacturing and Packaging Expertise

...

Breaking News | Facilities | Industry News

SCA to Expand Operations in Little Rock

Will invest more than $10 million and double its current workforce.

Contract Pharma Staff 07.23.20

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

Multimillion Dollar Investment Firmly Establishes Commercial Operations Globally to Support Business

PCI Pharma Services Announces Completion of Biotech Center of Excellence in Philadelphia and Expansions to Biotech Capabilities in Europe

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

A Guide to Vaccine Development from Lubrizol Life Science

The current COVID-19 pandemic emphasizes the need for safe and effective vaccines against new pathogens.

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 | Breaking News | Collaborations & Alliances | Industry News

bluebird bio Amends CAR-T Collaboration

Bristol Myers Squibb assumes responsibility for vector manufacturing in ex-U.S. territories

Contract Pharma Staff 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

Promotions & Moves

Centogene Appoints Interim CBO

Sun Kim succeeds Oved Amitay, who will be stepping down and leaving the Company.

Contract Pharma Staff 05.15.20

Pistoia Alliance Launches Toolkit for FAIR Data Principles

Backed by major pharma, the toolkit aims improve data management and data sharing, supporting AI and machine learning to advance the Lab of the Future.

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

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

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 | Collaborations & Alliances

Ori Biotech and CellGenix Collaborate

Promote innovation within closed-system cell and gene therapy manufacturing.

Contract Pharma Staff 05.13.20

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

Skyhawk Therapeutics, Merck Expand RNA Alliance

Aims to discover and develop novel small molecules that modulate RNA splicing for autoimmune and metabolic diseases

Contract Pharma Staff 05.13.20

cGMP Manufacture | CRO News | QA/QC

Parexel Launches COVID-19 Risk Mitigation Offering

Four-step methodology aims ensure manufacturers can safely continue manufacturing operations through the COVID-19 pandemic

Contract Pharma Staff 05.13.20

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

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

Promotions & Moves

BioDelivery Sciences Appoints Interim CEO

Jeffrey Bailey has led both public and private healthcare companies leveraging his leadership experience in commercial, supply chain and business development

Contract Pharma Staff 05.11.20

Viral aggregation in downstream processing of lentiviral vectors

...

Promotions & Moves

CorMedix Appoints CFO

Matt David, M.D. has more than 15 years of experience in finance as a healthcare investment banker and earlier as an equity analyst covering the pharma sector

Contract Pharma Staff 05.11.20

Breaking News | cGMP Manufacture | Industry News