MedPharm

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

APIs | Breaking News | cGMP Manufacture | Industry News

Piramal Pharma to Acquire Indian API Manufacturer Hemmo

Adds peptide API development and manufacturing capabilities for growing number of oncology and metabolic therapies.

Kristin Brooks 04.01.21

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 | 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

Breaking News | cGMP Manufacture | Industry News

EMA Approves BioNTech's COVID Vax Production at Marburg Site

Largest mRNA vaccine manufacturing site in Europe has annual production capacity of up to one billion doses of its COVID-19 vaccine.

Kristin Brooks 03.26.21

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

CyanVac and Exothera Enter COVID-19 Vaccine Partnership

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

Tim Wright, Editor, Contract Pharma 03.25.21

Breaking News | 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

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

ProBioGen, Nobelpharma Enter Mfg. Agreement for Vax Project

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

Kristin Brooks 03.24.21

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 | Drug Development | Facilities | Industry News | Parenterals

Eisai Begins Construction of New Injection/Research Building

To accommodate expanded drug discovery targets and new modalities such as antibodies, ADCs, and nucleic acid drugs.

Kristin Brooks 03.22.21

Genopis Renamed Wacker Biotech US

Plasmid DNA contract manufacturer was recently acquired by Wacker.

Tim Wright, Editor, Contract Pharma 03.19.21

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 | 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

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

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

Tevogen Bio, BioCentriq Partner for COVID T-cell Therapy

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

Kristin Brooks 03.16.21

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

Maravai Expands CDMO Capabilities Through TriLink Biotechnologies

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

Tim Wright, Editor, Contract Pharma 03.15.21

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

BioVaxys, Wuxi Biologics Enter Bioproduction Agreement

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

Tim Wright, Editor, Contract Pharma 03.15.21

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

Outsourcing Solid Dosage Manufacturing

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

Tim Wright, Editor, Contract Pharma 03.12.21

Bio News | Breaking News | Industry News

Cytovance Biologics Offers Licensing for Plasmid DNA Manufacturing

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

Tim Wright, Editor, Contract Pharma 03.09.21

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

Arranta Bio Invests in New Manufacturing Facility

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

Tim Wright, Editor, Contract Pharma 03.09.21

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

Vectura Expands Dry Powder Inhaler Capabilities

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

Tim Wright, Editor, Contract Pharma 03.09.21

Breaking News | 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

Breaking News | Industry News | Promotions & Moves

Sharp Appoints EU Qualified Person

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

Tim Wright, Editor, Contract Pharma 03.09.21

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

CatSci Opens New Site in UK

Strengthens analytical capabilities with the opening of a secondary site in Dagenham backed by a $4.2 million investment.

Tim Wright, Editor, Contract Pharma 02.25.21

Almac Group Completes $7M R&D Center

Significant expansion of biocatalysis, flow chemistry, and peptide capacity.

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

MaxiVAX, Minaris Enter Cell Therapy Mfg. Agreement

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

Kristin Brooks 02.22.21

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

Intravacc Unveils New Pilot Vaccine Production Facility

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

Tim Wright, Editor, Contract Pharma 02.19.21

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

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

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

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

Immunome, Abzena Enter COVID-19 Antibody Cocktail Agreement

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

Kristin Brooks 02.03.21

Sai Life Sciences Expands Capabilities

Plans to double headcount in Manchester and add a GMP Kilo Lab later in 2021.

Tim Wright, Editor, Contract Pharma 01.29.21

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

GRAM Makes Major Investment in Additional Advanced Equipment

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

Tim Wright, Editor, Contract Pharma 01.27.21

Breaking News | Formulation Development | Industry News | Methods Development

Adare Pharma Solutions Opens New Small-Scale Lab

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

Kristin Brooks 01.26.21

Breaking News | cGMP Manufacture | Excipients | Industry News

PromoCell Receives EXCiPACT Certification

Manufactures pharmaceutical excipients to GMP standards for tailor-made cell culture media and reagents that fulfill specific regulatory requirements.

Kristin Brooks 01.26.21

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

WDSrx Expands Warehouse Network

Pharma logistics company creates national network with expansion to Reno, NV.

Tim Wright, Editor, Contract Pharma 01.21.21

Clinical Trials

The Future of Clinical Trials Series: Part I

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

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

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

Bone Therapeutics, Rigenerand Ink Cell Therapy Deal

Enter an agreement for a process development partnership.

Contract Pharma Staff 01.19.21

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

Cognate BioServices Announces Major Expansion

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

Contract Pharma Staff 01.15.21

Breaking News | Collaborations & Alliances

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

Cytiva Delivers Modular Biologics Factory to Lonza

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

Contract Pharma Staff 01.14.21

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

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

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

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.

Abenza Promotes Kimball Hall to President

Hall also joins the Company Board.

Contract Pharma Staff 12.18.20

CHA Biotech Launches Global CDMO Biz

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

Contract Pharma Staff 12.16.20

[VIRTUAL LAUNCH] Redefining Virus Manufacturing with NevoLine™ Upstream

Directly from its development site in Belgium, Univercells Technologies is inviting you to join the virtual product launch of this breakthrough technology.

12.14.20

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

Recipharm Expands API Manufacturing Capabilities

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

Contract Pharma Staff 12.09.20

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

atbtherapeutics, iBio CDMO Enter Manufacturing Agreement

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

Contract Pharma Staff 12.09.20

Evotec and Sartorius Partner with Curexsys

Leverage IPSC platform for scalable manufacturing of Curexsys' exosome-based therapeutics.

Contract Pharma Staff 12.09.20

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

Piramal Invests $32M to Expand Michigan Facility

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

Contract Pharma Staff 12.08.20

Breaking News | cGMP Manufacture | Industry News

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

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

Keneka Eurogentec Joins Inovio’s Global Mfg. Consortium

Agrees to manufacture Innovio’s Covid-19 vaccine candidate INO-4800.

Contract Pharma Staff 12.03.20

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

Tubulis, WuXi Biologics and WuXi STA Form Strategic Pact

Will advance a new generation of antibody-drug conjugates towards clinical evaluation.

Contract Pharma Staff 12.03.20

Fujifilm Launches Sterile Express Media Service

Enables manufacturers to test the feasibility of formulations before scale-up to more costly GMP manufacturing.

Contract Pharma Staff 12.01.20

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

Breaking News | Facilities | Industry News

Abenza Upgrades Chemistry GMP Suites

Appoints new leadership at Bristol PA site.

Contract Pharma Staff 11.24.20

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

Samsung Biologics Partners with Eli Lilly

Accelerates the delivery of Covid-19 antibody treatments.

Contract Pharma Staff 11.20.20

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

Asahi Kasei Pharma Contracts ProBioGen

Will use ProBioGen’s technologies for the advancement of its biologics pipeline.

Contract Pharma Staff 11.18.20

Breaking News | Facilities | Industry News

CordenPharma Expands Peptide Development Capacity

Increases CoE for peptide development capacity to support European domestic growth.

Contract Pharma Staff 11.18.20

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

A Potential “Marriage”

Initiator companies and generics/CMOs working together.

Emil W. Ciurczak, DoraMaxx Consulting 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

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

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

G2GBio Deploys Micropore’s Membrane Technology

Plans to manufacture sustained release pharmaceutical products.

Contract Pharma Staff 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

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

Fujifilm Cellular Dynamics, Lonza Enter Cell Therapy Pact

Agree to expand availability and use of induced pluripotent stem cell technology.

Contract Pharma Staff 11.16.20

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.

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

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

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

Sensorion and Novasep Sign Agreement

Covers the development and manufacturing of AAV vectors, a key step for Sensorion’s gene therapy programs.

Contract Pharma Staff 11.03.20

Bio News | Breaking News | cGMP Manufacture | Industry News

eTheRNA Extends mRNA Production Services

Adds high throughput research grade mRNA to its GMP capabilities.

Contract Pharma Staff 11.03.20

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 | Industry News | Promotions & Moves

Frontida BioPharm Names Steven Roese as Vice President, Quality

...

Contract Pharma Staff 10.30.20

Breaking News | Industry News

MilliporeSigma Awards Grant to Combined Therapeutics

Supports its nucleic acid platform that targets liver cancer with virotherapy.

Contract Pharma Staff 10.28.20

Breaking News | Industry News | Promotions & Moves

Valicare Expands Service Portfolio

Recruits Dr. Christin Erbach as senior GMP consultant.

Contract 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

3P Biopharmaceuticals and SpyBiotech Enter Vaccine Contract Manufacturing Agreement

Looking towards completing production in 2021.

Contract Pharma Staff 10.26.20

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

ProBioGen, Heidelberg Pharma Ink ATAC Agreement

ProBioGen is conducting cell line development, process development and GMP manufacturing of the mAb intermediates of Heidelberg’s ATAC molecules for cancer.

10.22.20

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

Clinical Trials | Information Technology

The Role of Electronic Monitoring in Maintaining Medication Adherence

Digital solutions offer hope to get patients to take their medications properly.

Bernard Vrijens, Scientific Lead, AARDEX Group 10.14.20

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 | Breaking News | Facilities | Industry News

CellGenix Expands Facility

Meets the growing demand for GMP raw materials.

Contract Pharma Staff 10.13.20

Breaking News | Collaborations & Alliances | Industry News

BryoLogyx Completes World’s First GMP Synthesis of Bryostatin-1

Partnered with CDMO AMRI for GMP synthesis.

Contract Pharma Staff 10.13.20

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

Fujifilm Diosynth to Manufacture Lilly COVID-19 Antibody

Commercial manufacturing of the antibody therapy is expected to commence in April 2021.

Contract Pharma Staff 10.13.20

Analytical Services | Breaking News | Formulation Development | Industry News | Laboratory Testing

Cambrex Completes Edinburgh Expansion

Doubles the facility's footprint to 15,000 sq.-ft., existing lab space is refurbished, and an additional 3,500 sq.-ft. of lab space added.

Contract Pharma Staff 10.12.20

Abzena Invests $60M Into cGMP Manufacturing Capacity

New facility in San Diego houses a process development laboratory and two new cGMP manufacturing cleanrooms.

Contract Pharma Staff 10.08.20

Biologics, Proteins, Vaccines | Breaking News | Industry News

Mapi Pharma Commissions Facility to Support Supply of COVID-19 Vaccines

Makes available its production, cold-chain and storage capacities for the delivery of vaccines to Israel and the EU.

Contract Pharma Staff 10.08.20

Breaking News | 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 | 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

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

GT Biopharma and Cytovance Biologics Expand Partnership

Cytovance will be the exclusive GMP manufacture for three of the company's TriKE therapeutic product candidates.

Contract Pharma Staff 10.06.20

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

Cobra Biologics to Manufacture Plasmids for COVID-19 Vax Trial

Collaboration will ensure GMP production of material for Phase I clinical trial of Scancell’s DNA vaccine against SARS-CoV-2.

Contract Pharma Staff 10.05.20

Breaking News | Promotions & Moves

3P Expands Management Team

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

Contract Pharma Staff 10.02.20

APIs | Breaking News | Industry News

NCK A/S Receives CoA for Berubicin API

CNS has a contract with NCK A/S for the large-scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors.

Contract Pharma Staff 10.01.20

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

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

JanOne Prepares for GMP Production

Bottling and labeling of clinical trial batches are expected to begin in early October led by Eurofins CDMO.

Contract Pharma Staff 09.08.20

Breaking News | Excipients | Facilities | Industry News

JRS Pharma Receives EXCiPACT GMP Certification for the Production of MCC

The certificate for Changzhou, China facilities helps drug manufacturers reduce efforts and costs.

Contract Pharma Staff 09.01.20

Bio News | Breaking News | Facilities | Industry News

Luina Bio Expands

Announces new bio-manufacturing GMP and development facilities.

Contract Pharma Staff 09.01.20

Q BioMed Initiates GMP Production of Novel COVID-19 Therapeutic

COVID-19 clinical trial planned for Q1 2021 supported by Canadian Government.

08.28.20

Tetra Bio-Pharma and Dalton Pharma Enter GMP Manufacturing Tie-up

Significant advancement achieved with ARDS-003 sterile injectable nano-emulsion finished drug product.

Contract Pharma Staff 08.20.20

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

JanOne Readies for Clinical GMP Manufacturing Run

JAN101 formulation ready for Phase 2b peripheral artery disease trials and for potential treatment of COVID-19 vascular inflammation.

Contract Pharma Staff 08.20.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development

SwiftScale Manufactures COVID-19 Antibody Candidate

Uses rapid biologics manufacturing technology to accelerate development of treatments.

Contract Pharma Staff 06.09.20

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.

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

Breaking News | Facilities | Industry News | Inspections

PharmaCyte Conducts Final Audit of Mfg. Facility

Batch records in Thailand have been deemed cGMP compliant

Contract Pharma Staff 05.18.20

Exyte and Univercells Join Forces

Partner for rapid deployment of vaccine production plants in the wake of the COVID-19 crisis

Contract Pharma Staff 05.14.20

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

CMAB Completes Devt. and Mfg. Project for QureBio

Bispecific antibody Q-1802 will enter clinical trials to assess treatment of solid tumors such as gastric cancer

Contract Pharma Staff 05.14.20

Vibalogics to Manufacture Clinical Material for Janssen

CDMO to provide additional clinical trial material for COVID-19 vaccine candidate

Contract Pharma Staff 05.14.20

Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News

Sabin and ReiThera Enter Clinical Manufacturing Pact

BARDA provides the Sabin Vaccine Institute with additional $20mn for further development of Ebola Sudan and Marburg vaccines

Contract Pharma Staff 05.14.20

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

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

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

Singota Solutions Collaborates with Noveome Biotherapeutics

To manufacture therapy to treat severe condition in people infected with COVID-19

Contract Pharma Staff 05.12.20

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

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

Biopharmaceutical Process Characterization

On June 11, Samsung will demonstrate process understanding needed to develop a robust & scalable mfg process to support successful GMP manufacture of biologics

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

Breaking News | Collaborations & Alliances | Industry News

InMed, Almac Improving Cannabinoid Production Methods

Partner to develope a streamlined cannabinoid manufacturing process

Contract Pharma Staff 05.08.20

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

Nanoform Awarded GMP Certification

To manufacture investigational drug developed using its CESS nanoparticle engineering platform for use in clinical trials.

Contract Pharma Saff 05.05.20

Breaking News | Industry News

MedPharm Expands Testing Models to Target Coronavirus

Helps accelerate treatment development prior to clinical trials

Contact Pharma Staff 04.28.20

THE CENTRE FOR CELL AND VECTOR PRODUCTION (CCVP)

A Transparent and Flexible Approach to Manufacturing

Road to success: Understanding Good Laboratory Practice for cell and gene therapies

...

Breaking News | Clinical Trial Materials | Drug Delivery | Industry News

Phillips-Medisize Expands Clinical Mfg. Capabilities

The facility is designed to support late stage development of medium- and high-volume products and processes under GMP

01.10.20

Breaking News | Promotions & Moves

MedPharm Appoints North American VP

Lynn Allen brings extensive experience in topical and transdermal contract development and manufacturing

12.18.19

Breaking News | CRO News | Facilities | Industry News

CatSci Expands Capabilities with Lab Expansion

Continuing strategic growth.

CatSci 12.11.19

Breaking News | cGMP Manufacture | Industry News

Thermo Fisher Opens $90M Viral Vector Mfg. Site

The facility will create 200 new jobs and support the development, testing and manufacture of viral vectors.

12.05.19

Breaking News | cGMP Manufacture | Clinical Trial Materials | GMPs/GCPs | Industry News

CureVac Granted Mfg. Authorization for GMP Production Suite

GMP Production Suite scales up capacity for preclinical, clinical and early launch needs for proprietary and partnered programs

12.03.19

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

Polyplus-transfection Expands GMP Portfolio

New GMP conditioning of PEIpro-GMP designed to support clinical phase and commercialization stages of production

12.03.19

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

Yourway Expands Global Footprint

Opens new depot in Mumbai, India.

11.27.19

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

HALIX Opens State-of-the-Art cGMP Facility

New facility for the development and manufacturing of biopharmaceuticals.

11.22.19

Breaking News | Facilities | Industry News | Inspections

Metrics Completes Japanese Regulatory Inspection

Marks the first international inspection of the company’s new 126,000-square-foot commercial manufacturing facility constructed in 2018.

11.18.19

Reader Showcase

Thermo Scientific Introduces Handheld IonicX Analyzer

Designed to allow pharma and biopharma manufacturers to verify the identity of ionic salts in the warehouse in seconds

11.15.19

Arranta Bio Acquires Captozyme

Creates a CoE for microbiome development and clinical supply.

11.13.19

Breaking News | Industry News

CPhI’s 16th Pharma Awards Winners

Dr. Ge Li wins ‘CEO of the Year’ and John Chiminski a ‘Lifetime Achievement’ award.

11.13.19

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

IDT Biologika, NIH Mfg. Contract Updated

Awarded new task order in the scope of 10-year NIH contract to manufacture vaccines and biologics for infectious diseases.

11.11.19

Notch Therapeutics – a new company with a revolutionary allogeneic T cell technology

(“off the shelf”)

Bioanalytical Services | Clinical Trials | Industry News | Laboratory Testing

Recipharm Divests Bioanalysis Biz

Expands existing partnership with CTC Clinical Trial Consultants AB.

11.04.19

Planning Is Everything - Quality Control Testing in Cell and Gene Therapy

...

Five Steps to Ensure Your Cell and Gene Therapy Product Is GMP Compliant

When we think about CGTs what most often comes to mind is the early stage scientific innovation responsible for finding new ways to treat diseases.

Breaking News | Capsules | Facilities | Industry News

CDMO to Invest Over €3M in GMP Facility Expansion

Micro-Sphere will add an additional spray drying line to its facility in Switzerland.

10.28.19

Valsynthese

Custom manufacturer with focus on development and synthesis under GMP and ISO 9001 environment.

10.24.19

IQ, OQ and PQ: Why Are They Important in the Manufacturing of Cell and Gene Therapies?

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Clinical Trial Materials

Overcoming the Small Molecule Bioavailability Challenge

Approximately 90% of preclinical compounds are estimated to face bioavailability challenges.

David Lyon, Sr. Research Fellow, Lonza Pharma & Biotech 10.15.19

cGMP Manufacture

Deriving Value from Integrated cGMP and Pre-GMP Manufacturing Operations

The benefits of leveraging a mix of GMP and pre-GMP facilities.

Didier Combis, Commercial Director, Seqens CDMO 10.15.19

Breaking News | GMPs/GCPs | Industry News | Inspections

ASIT biotech Receives GMP Certification

Site in Liège, Belgium to manufacture in-house the active pharmaceutical ingredient of its leading product for grass pollen allergies

10.07.19

Breaking News | Industry News | Inspections | Regulatory Affairs

Almac Completes Three Regulatory Inspections

Inspections at Charnwood, Craigavon, and Audubon sites successful

09.27.19

Contracting And Outsourcing Exhibitor List

...

09.17.19

APIs | Regulatory Affairs | Supply Chain

API Supply Chain Strategy

How to risk-proof your API supply chain for a successful 505(b)(2) filing.

Shailesh Vengurlekar and Hamilton J. Lenox, LGM Pharma 09.16.19

GE Healthcare and Germfree to Advance Manufacturing of Novel Biotherapeutics

Manufacturing solution will feature a Germfree modular bioprocessing environment

09.16.19

Breaking News | Industry News | Solid Dosage/Creams/Ointments | Solid Dosage/Semi-solids

Upperton Pharma Solutions Investment Increases Tabletting Capabilities

New Futorque X tablet press is designed to support R&D studies and production batches

09.16.19

CMAB Receives Positive Opinion Following External Quality Audit

CDMO’s fully integrated facility in Suzhou, China was found to conform to EU Eudralex Vol. 4 GMP guidelines

09.10.19

Pfizer Invests $500M in Gene Therapy Facility

The Sanford, NC site to support continuing investment in gene therapy R&D

08.21.19

cGMP Manufacture | Clinical Trial Materials | Industry News | Process Development | R&D

IBBR Seeks RFPs for cGMP Biologics Manufacturing

Facility is also equipped to perform process development research, preclinical manufacturing for IND-enabling tox studies, Point of Concept studies

08.19.19

Industry News | Process Development

Cambrex Expands Process Development at Edinburgh Facility

Doubles current footprint to 15,000 sq. ft., adding lab space to accommodate 40 more scientists

07.30.19

Collaborations & Alliances | Formulation Development

MedPharm Expands Relationship With Novan

Aims to progress the development of in vitro models focused on Novan’s nitric oxide product technology

07.23.19

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

Mapi to Establish New Sterile Production Plant for GA Depot

Mapi will supply GA Depot to Mylan for commercial sale

07.16.19

Breaking News | Industry News | Logistics | Packaging & Tracking

Marken Acquires Three European Logistics Companies

Expands logistics footprint in Italy, Austria and Hungary

07.15.19

Analytical Services | Laboratory Testing

Re-Open Your Tool Chest

There’s no longer an excuse NOT to start “PAT-ing” your products

Emil W. Ciurczak, DoraMaxx Consulting 07.15.19

Breaking News | Excipients | Facilities | Industry News

Colorcon Expands Excipients Business

To build starch manufacturing plant near Amsterdam

07.15.19

Biologics, Proteins, Vaccines | cGMP Manufacture | Industry News

WuXi Biologics Plans to Further Expand New Bioconjugation Center

To include commercial manufacturing in Wuxi City, China

06.21.19

Breaking News | Collaborations & Alliances | Industry News

Hoth Signs Contract Service Pacts for BioLexa

Particle Sciences, Regis Technologies called on for upcoming toxicology and clinical trials

06.18.19

Biologics, Proteins, Vaccines

Advancing Cell and Gene Therapies

Amy DuRoss of Vineti discusses the key challenges cell and gene therapies face and advances to enhance safety, speed, and access

Kristin Brooks, Contract Pharma 06.10.19

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

Abzena Bolsters Development Timeline Capabilities

Unveils 14-month cell line to phase 1 GMP service; appoints Shahram Katousian as head of biologics manufacturing

06.10.19

cGMP Manufacture | Clinical Trial Materials | Industry News

Phoenix Molecular, WuXi STA Reach Drug Supply Milestone

Completes clinical trial supply to support Phase I/Ib study of PMD-026 for TNBC

06.07.19

Bio News | Biologics, Proteins, Vaccines | cGMP Manufacture

Aldevron to Build 14-Acre Gene Therapy Mfg. Campus

Annual capacity will exceed $1 billion of plasmid DNA, RNA, gene editing enzymes, and other biologics

06.03.19

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

iBio Launches Sterile Fill-Finish Services

Initial capacity supports 100 – 2,500 vials runs, with plans to expand to 15,000

06.03.19

Bio News | Breaking News | Industry News

Catalent Completes Paragon Acquisition

$1.2 billion deal for gene therapy leader is final

05.20.19

Breaking News | GMPs/GCPs | Industry News

LSNE Receives GMP Certification by Brazil's ANVISA

Marks the first LSNE manufacturing facility to receive ANVISA certification

05.14.19

Breaking News | Industry News | Promotions & Moves

Paragon Strengthens Leadership Team

John Mosack head GMP mfg. at Baltimore site; Adam Sachs to lead program mgmt. and client alliance; Deborah Wild is chief quality and reg. affairs officer

05.08.19

Facilities | Solid Dosage/Creams/Ointments

ACG’s New $91M Brazil Facility

Touts major expansion of capsule manufacturing capabilities at CPhI

05.08.19

Information Technology

My Head is in The Cloud(s)

Cloud computing is making it easier to control all aspects of the global pharma production process

Emil W. Ciurczak, DoraMaxx Consulting 05.07.19

3P Bio, Intervacc Secure Large-Scale Mfg. Process

Tech transfer and scale-up of the mfg. process with verification of reproducibility for Strangvac production has been completed

05.06.19

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

Micro-Sphere Partners With PTM Consulting

Will offer customers support across the entire drug product development and manufacturing cycle

05.06.19

Biologics, Proteins, Vaccines | cGMP Manufacture | Industry News

Precigen Opens Cell Therapy Mfg. Facility in MD

The 5,000 square foot facility in Germantown will manufacture early stage clinical trial material for gene therapy trials

04.26.19

Analytical Services | Breaking News | Industry News

Almac Expands Global Analytical Services Capability

To bolster operations at its Athlone facility

04.15.19

cGMP Manufacture | Industry News

Paragon Opens New Biomanufacturing Facility in MD

New facility is equipped with several 500L and 2000L single-use bioreactors for clinical through commercial material production

04.12.19

Director of Engineering

Renaissance Pharmaceuticals

Industry News

YMC Acquires ChromaCon Biz

Expands footprint in multi-column continuous purification technologies

04.10.19

Excipients

Pharmaceutical Excipients Trends

They’re not just unimportant background noise anymore.

Emil W. Ciurczak, DoraMaxx Consulting 04.05.19

Clinical Trial Materials

Clinical Trial Supply: The Pathway to Success

Early phase development and manufacture must be done quickly and efficiently to help keep costs low.

Torkel Gren, Senior Director, Science & Technology Officer, Recipharm 04.05.19

LakePharma Enhances Mfg. Operations

Launches GMP manufacturing of recombinant proteins and antibodies in the Bay Area

04.05.19

Bio News | cGMP Manufacture | Facilities | Industry News | Inspections

WuXi STA Mfg. Facility Passes GMP Inspection

New drug product manufacturing facility in Waigaoqiao Free Trade Zone of Shanghai has passed its first GMP inspection by the European Medical Products Agency

03.27.19

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

Abzena Launches Developability and Optimization Service

Designed to improve lead selection and de-risk biologic cell line development

03.25.19

Breaking News | Promotions & Moves

Paragon Bioservices Appoints New CTSO

Bolsters leadership ranks to support late-stage clinical and commercial biopharma manufacturing

03.22.19

Breaking News | Industry News

Sheba, Lonza Collaborate on Cell Therapy Mfg. Platform

Will assess automated CAR-T cell therapy manufacturing at the point-of-care

03.18.19

APIs | Breaking News | Industry News

Sterling Pharma Solutions Acquired by GHO Capital

Sterling provides API development and GMP manufacturing services

03.14.19

Leak Rate Testing for Freeze Dryers: A Scientific Approach

Assurance of the vacuum integrity of freezedryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations.

Nutraceutical Brands Find Relief in Outsourcing Manufacturing

More companies are working with contract manufacturers to manage resources and focus on business development.

Sean Moloughney, Editor, Nutraceuticals World 03.06.19

Information Technology

Industry 4.0 in the Pharma Industry

Digitization is not a single-handed project.

Dr. Christian Hanisch, Project Manager Industry 4.0 Pharma, Bosch Packaging Technology 03.06.19

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

ACG Capsules Expands in Brazil

ACG Capsules opens a new factory in Pouso Alegre-MG, the second in the region

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

3SBio, Verseau Establish Immuno-Oncology Devt. Collaboration

3SBio will fund and conduct antibody development and GMP manufacturing

02.11.19

MedPharm & Palvella Expand Partnership

For developing a new treatment for the debilitating rare disease, pachyonychia congenita

02.11.19

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

Upperton Pharma’s Nottingham Site Passes MHRA Inspection

Gains licenses for manufacture, downstream processing into capsules and tablets, as well as spray dried formulations of biotherapeutics and small molecule APIs

01.16.19

MedPharm to Expand US Center of Excellence

An investment of $4M in the expansion and equipment will more than triple the size of the current US facility to 25,000 sq. ft

01.14.19

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

Catalent to Expand Biologics Capacity and Capabilities

To invest $200 million in its manufacturing sites in Madison, WI and Bloomington, IN

01.07.19

Breaking News | Facilities | Industry News

Almac Launches Second Line for High Throughput GMP Peptide

New facility will be based in Edinburgh

01.04.19

PPD Expands GMP Lab Testing Capabilities for Biologics

Enhances gene and cell therapy lab services across Europe and North America

12.26.18

3P Biopharmaceuticals Completes Facility Expansion

Investment exceeds €5 million

12.26.18

HemaCare Moves Into New HQ

Company has officially moved its global headquarters to Northridge, California, in a 40,000 sq. ft. building in the heart of the San Fernando Valley

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

Lonza to Establish Bio Mfg. Base in China

Will leverage GE Healthcare’s off-the-shelf biologics factory, KUBio, to provide the base for GMP manufacturing

12.10.18

PPD Expands GMP Lab Testing Capabilities

Adding 6,000 sq. ft. of gene and cell therapy analytical testing to Athlone, Ireland facility

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

ABL Expands GMP Viral Vector Mfg. Capacity

Acquires state-of-the-art facility in Lyon, France

12.03.18

cGMP Manufacture | Fill/Finish | Parenterals | Solid Dosage/Creams/Ointments

Glenmark Establishes U.S. Ops

Robert Matsuk, president of North America at Glenmark discusses the significance of the new NC site

Kristin Brooks, Contract Pharma 11.28.18

Bio News | Industry News | Promotions & Moves

MedPharm Appoints President & CEO

With over 25 years industry experience, Eugene Ciolfi has also been appointed to MedPharm’s Board of Directors

11.28.18

Rentschler Inaugurates New Fill and Finish Facility

New high-tech facility to be used for the aseptic filling and freeze-drying of drug products

11.20.18

Analytical Services | Laboratory Testing

The Great Diaspora of the Pharma Industry

Or, good things come in small(er) packages

Emil W. Ciurczak, DoraMaxx Consulting 11.14.18

Analytical Services | Breaking News | Drug Development | Drug Discovery | Industry News

Concept Life Sciences Expands GLP Capabilities

MHRA confirms GLP extension at Dundee and Bradford sites

11.08.18

Bio News | cGMP Manufacture | Facilities | Industry News | Process Development

Glenmark Opens First U.S. Mfg. Site

100,000 sq.-ft. North Carolina facility is designed to manufacture a variety of fixed dose pharma formulations

10.31.18

Laboratory Testing | Methods Development

Advanced Analytical Features Services

Michelle Gonzalez, Client Services Specialist, spoke exclusively with Contract Pharma at Contracting & Outsourcing 2018

Solid Dosage/Creams/Ointments

Semi-Solid Dosage Forms

Novel treatments and overarching trends in semisolid formulation development and manufacture.

Nigel Walker, Nice Insight / That’s Nice LLC 10.10.18

ZipDose® 3DP Technology Platform for Pharma, from Aprecia®

It's the first and only to be FDA-validated and ready today for commercial-scale drug development.

Logistics | Process Validation | QA/QC

Nulogy Launches Quality & Compliance Solution

Capabilities provided to contract packagers are purpose-designed for compliance and GMP compatible and unique to the market

Betsy Louda, Associate Editor 10.04.18

APIs | Bio News | cGMP Manufacture | Facilities | Industry News

PharmaBlock Acquires cGMP Mfg. Facility

The 1,436,000ft2 (approximately 133,400m2) site was purchased from Porton Pharma Solutions Ltd

10.02.18

Bio News | Collaborations & Alliances | Industry News

Cambrex Completes Halo Acquisition

Initially announced in July 2018, the deal closed for approximately $425 million

09.12.18

Clinical Trial Materials | Supply Chain

Clinical Trial Supplies Planning and Management

There are a significant number of factors that affect the complexity of planning and managing clinical supplies.

Kristen DeVito, Global Director, Clinical Supply Business Solutions, Catalent 09.11.18

cGMP Manufacture | Drug Development

Benefits of the One-Stop-Shop CDMO

One provider for many solutions can offer support for the entire product value chain

Dr. David Brett, Vetter Pharma International GmbH 09.11.18

Alcami, UNCW Awarded $1.12M Biomfg. Grant

Project Call 1.0 proposal selected by NIIMBL governing committee

08.31.18

Bio News | Breaking News | cGMP Manufacture | Industry News

Dalton Pharma, Arch Biopartners in Mfg. Tie-up

Dalton to perform the GMP campaign for Metablok

08.17.18

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

WuXi Biologics, Immune Enter Agreement

For the production of bertilimumab, Immune’s first-in-class anti-eotaxin-1 monoclonal antibody

07.09.18

Capabilities Brochure - The Promise of Science Maximized

...

Enamine and TBD Biodiscovery Collaborate to Provide GMP-based Services

Collaboration combines expertise in novel chemical compound synthesis with GMP manufacture in drug discovery

06.20.18

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

PPD and NeoGenomics Form Global Strategic Alliance

Expanding global oncology testing for clinical trials

06.01.18

cGMP Manufacture | Collaborations & Alliances | Drug Development | Facilities | Industry News

Eurofins, Astellas Sign Outsourcing Agreement

Astellas has committed to provide ASL work covering its current capacity for an agreed period of time

05.29.18

Analytical Services | Drug Delivery | Industry News

West Introduces New Analytical Services

Capabilities aim to address challenges concerning packaging, delivery and combination product needs

05.16.18

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

Wacker Buys Dutch Biotechnology Plant

Takes over Synco Bio of Amsterdam; strengthens pharmaceutical protein business

04.17.18

Information Technology

New GXP Data Integrity Guidance Published by MHRA

Robert Marohn, ClinLogic, LLC 04.10.18

How Does Work Get Done In Pharma? By PEOPLE!

A high-octane primer on talent development for better business performance

Ben Locwin, Contributing Editor 04.10.18

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

Quay Pharma Launches New GMP Suites

As part of an investment in the company's live biotherapeutics services

04.04.18

Analytical Services | Bioanalytical Services | Industry News | Information Technology | Laboratory Testing

MedPharm Adds Robot Technology to Facility

The near $1M investment covers the latest Hamilton Vantage robot for sample handling

03.08.18

cGMP Manufacture | Clinical Trial Materials | Facilities | Industry News

LakePharma Launches GMP Manufacturing Center

The 69,000-square foot building includes laboratory, office space and infrastructure for GMP manufacturing

02.14.18

Breaking News | Facilities | Industry News

MedPharm to Expand Laboratory

The expansion aims to increase its laboratory footprint in the UK by 60%

02.14.18

Breaking News | GMPs/GCPs | Industry News

Shaanxi Aoxing Pharmaceutical Renews GMP Certification

Company will resume production in the coming months

02.09.18

2018 Pharma Industry Outlook

The importance of quality and safety, especially in times of change

Johannes Rauschnabel, Chief Pharma Expert, Bosch Packaging 01.30.18

Collaborations & Alliances | Drug Development | Industry News

Frontida and Oncoceutics Enter Development Collaboration

To further develop the product manufacturing process for ONC201, Oncoceutics’ lead molecule

01.09.18

Phase Specific Test Method Lifecycle and Lab Quality Practices from R&D to GMP

...

12.06.17

Clinical Trials | Information Technology | Reader Showcase

Almac Expands IXRS 3 IRT Platform

Adds Accountability and Reconciliation Tracking (ART)

10.24.17

Drug Development

Making Medicines: Speeding the Path from Idea to Patient

Speeding the path from idea to patient

Dan Bowles and Michael Tracey, Cambrex 10.11.17

Breaking News | cGMP Manufacture | Clinical Trial Materials | Fill/Finish | Industry News

Dalton to Start GMP Mfg. for Inhalation Drug Candidate

Arch Biopartners expects AB569 to enter phase I later this year

05.05.17

Recipharm Opens GMP Suite for Clinical Trial Materials

$750k investment will focus on non-sterile dosage forms including metered dose inhalers and semi-solid topical products

04.24.17

VWR Receives EXCiPACT Certifications

Pharma excipient supplier is GMP and GDP approval at two chemical mfg. sites

01.24.17

Breaking News | GMPs/GCPs | Industry News

PPD Expands Stability Storage and Sample Distribution

Increase in capacity and capabilities at Wisconsin GMP lab designed to support growing client needs

12.14.16

Analytical Services | Industry News | Laboratory Testing | Methods Development

GVK BIO Launches Analytical Services Lab in India

To offer development and validation of research methods and compendial testing of API, finished products and raw materials

12.02.16

cGMP Manufacture | Industry News | Solid Dosage/Creams/Ointments

BioDuro Expands Spray Drying Mfg. Capacity

Adds SPX Anhydro MicraSpray 150 at San Diego facility

11.08.16

Catalent Biologics Forms Agreement With Moderna Therapeutics

Designed to support cGMP clinical manufacturing of Moderna’s mRNA personalized cancer vaccine

10.13.16

Drug Delivery | Formulation Development | Industry News

MedPharm Opens U.S. Facility in Research Park Triangle

Will serve growing dermatology market

09.29.16

Formulation Development | Validation

Altimmune Receives $120M BARDA Contract

Funds support research for clinical development of first-in-class anthrax vaccine candidate NasoShield

08.01.16

cGMP Manufacture | Clinical Trials | Industry News | Solid Dosage/Creams/Ointments | Validation

Juniper Pharma Services Expands Tablet Mfg. Capabilities

Adds RoTab tablet press by kg-pharma

06.21.16

SGS, DiscoverX to Qualify and Supply Bioassays

Aims to provide commercial ready-to-assay cryopreserved cells in a qualified kit

03.30.16

Breaking News | Clinical Trial Materials | Clinical Trials | CRO News | Formulation Development

Quotient Clinical Completes Japanese Bridging Study

Uses Translational Pharmaceutics platform

03.17.16

Chemistry | Inspections

Are Your Nutritional Supplements Safe?

...

Ben Locwin, Contributing Editor 03.09.16

Capsules | Clinical Trials | Formulation Development | Industry News

Juniper Pharma To Reformulate Phase II PharmAust Drug

Will reformulate monepantel due to unpleasant taste

02.01.16

Analytical Services | Laboratory Testing

Pharmaceutical Manufacturing Use of TOC Water Monitoring

Denni DiBiagio of PMRS discusses the Sievers 500 RL On-Line TOC Analyzer, which is used to monitor organics in GMP water

Follow-on Growth for SGS After QCL Purchase

Acquisition leads to expansion and integration of chemistry and microbiology testing services

01.19.16

Catalent Biologics Expands Capabilities

New investments have been made in response to increased industry demand

11.20.15

Custom Sourcing News | Excipients | GMPs/GCPs | Industry News | Regulatory Affairs

NSF Earns ANSI Accreditation

Can now certify excipient manufacturers to cGMP Standard

10.30.15

cGMP Manufacture | Collaborations & Alliances | Solid Dosage/Creams/Ointments | Supply Chain

Pfizer, GSK in OSD Mfg. Equipment Alliance

To develop next-gen design of Pfizer’s PCMM prototype for OSD development and manufacturing

10.29.15

Information Technology | Logistics | Packaging & Tracking | Promotions & Moves | Serialization

Adents Appoints Senior Director

Bronander to Lead North American expansion

10.16.15

Breaking News | cGMP Manufacture | Facilities | GMPs/GCPs | Industry News

Evonik Achieves GMP Certification

Relates to pharmaceutical-grade hydrogen peroxide made at its Weissenstein facility

10.08.15

Aseptic Processing

Moving Towards Green Barrier Systems?

A comparison of energy consumption in RABS and isolators

Johannes Rauschnabel, Ph.D., Bosch Packaging Technology 10.07.15

WuXi Receives First Approval from Japanese Regulatory Authorities

Subsidiary STA will manufacture intermediate of a branded commercial drug

08.27.15

Analytical Services | Breaking News | cGMP Manufacture | Formulation Development | Industry News

Quotient Clinical Expands Pharma Capacity

Doubles capacity with a second GMP manufacturing facility and new formulation development and analysis labs

07.14.15

Juniper Partners with OxSonics on Drug Delivery Platform

Will support development, scale-up, and GMP manufacture of sono-sensitive injectable particles

06.23.15

ScinoPharm, Raffles PharmaTech Ink API Alliance

Will manufacture Celecoxib, a non-steroidal and anti-inflammatory analgesic API

06.23.15

Catalent Expands Packaging Capabilities in Singapore

Catalent Singapore facility is awarded GMP certification

06.16.15

Quotient Clinical Delivers First In-human Program for Corcept Therapeutics

Focus is on treatment of Cushing’s syndrome and certain cancers

06.10.15

Breaking News | Clinical Trials | Industry News

PPD Laboratories Opens Central Lab in Shanghai

Provides clients with broad range of standardized lab testing services and capabilities

04.20.15

Analytical Services | APIs | Breaking News | Clinical Trial Materials | Industry News

Onyx Scientific Expands GMP Capabilities

Will install a new Class 100,000 suite at its North East England facility

03.30.15

SGS Expands Analytical Services in Germany

Offers range of analytical methods to identify amino acid impurities

02.18.15

Supply Chain

Vietnam’s Pharma Industry

The healthcare market in Vietnam is an attractive destination for investment.

Dr. Gurpreet Sandhu, Reva Pharmachem 01.29.15

Breaking News | Clinical Trial Materials | Collaborations & Alliances

Tekmira in Ebola Therapeutic CTM Pact with Oxford U

GMP manufacture of TKM-Ebola-Guinea is complete and 100 treatment courses are available

12.22.14

Breaking News | Industry News | Inspections

Hovione’s Loures Plant Completes FDA Inspection

Site compliant with GMP but Form 483 notes three inspectional observations

12.17.14

Recipharm Acquires Facility in France

Expands development capacity and technical capabilities

12.01.14

MEGGLE Gains EXCiPACT Certification

Complies with the quality GMP & GDP standards

09.04.14

AIBioTech Acquires ImmunoTox

Kemwell expands lyophilization capacity

04.03.14

Quincy Bioscience Receives NSF GMP Recertification

Manufacturing methods in accordance with FDA’s 21 CFR part 111

Kristin Brooks 02.28.14

NSF Acquires IPEC Auditing Arm

Adds auditing and certification of excipients

Kristin Brooks 02.10.14

IRCA Launches New GMP Auditing Scheme

Aims to establish global auditing standards

Kristin Brooks 01.16.14

Breaking News | Capsules | Clinical Trial Materials | Industry News | Regulatory Affairs

IDIFARMA Gains Authorization for New Dosage Forms

Expanded GMP capabilities include powders, tablets, and hard capsules

Kristin Brooks 01.13.14

MedPharm Opens New GMP Facility

Expands clinical manufacturing capabilities

10.09.13

Newsmakers: Frithjof Holtz on EXCiPACT

...

Gil Y. Roth, Contract Pharma 10.09.13

Breaking News | Industry News | Inspections

Hovione’s Portugal Site Passes Inspection

Successfully passes 12 inspections in 18 months

10.03.13

Breaking News | Industry News | Process Development

Gallus Acquires Laureate

Expands biologics CMO business Laureate

10.01.13

Drug Development | Drug Discovery

Rules for Discovery

Wisdom from the early phase

Derek B. Lowe, Contributing Editor 09.05.13

SPS Pharma Relocates to Larger Site

Expands range of analytical services

07.23.13

Intertek Acquires Melbourn Scientific

Expands drug characterization expertise

07.09.13

GMP Annual Training - Exploring Good Manufacturing Practices Updates and Health Canada/FDA Regulatory Expectations

...

05.20.13

MedPharm Opens Topical Testing Lab

Supports growth of skin permeation/penetration and testing services

05.07.13

Breaking News | Industry News | Inspections | Logistics

Vetter’s New Facility Completes FDA Inspection

RVW provides cold storage and visual inspection

03.28.13

Understanding and Implementing GMP & GLP – FDA & Health Canada

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03.20.13

Hovione, Solvias in Solubility Pact

Aims to overcome poor bioavailability

11.28.12

GMP for Animal Studies CTM

What level of GMP need to be followed for clinical trial materials (for a generic ANDA) intended for animal studies if the drug is already in the market?

10.05.12

Breaking News | Industry News | Inspections

Sinovac Gains GMP Certification from SFDA

Will commence mumps vaccine production

09.18.12

Aesica, U of Bradford in CT Supply Pact

Provides GMP manufacturing services for research

08.30.12

Combatting the Counterfeiters

Technological trends and legislative developments

Elke Sternberger-Rutzel 04.04.12

Breaking News | Lyophilization | Promotions & Moves

Avrio Appoints President

Botha brings 24 years of experience

03.22.12

Good Manufacturing Practice (GMP)

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02.27.12

GxP

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02.27.12

ABL Hires Bioprocessing Leader

Zhang joins GMP team

Gil Roth 12.13.11

Supply Chain Focus: Purity Matters

Third-party certification of propylene glycol USP/EP: one answer to supply chain concerns

Vincent Lacoste 10.11.11

Breaking News

Cobra Biologics Re-brands Recipharm Unit

Offers integrated and stand-alone development services

10.03.11

Breaking News | Industry News | Inspections

SGS Wavre Site Gets WHO Prequalification

Second site added to WHO lab list

Gil Roth 06.14.11

Breaking News | Drug Delivery | Industry News

Labtec Opens GMP Facility in Germany

Labtec GmbH, a subsidiary of tesa SE, has opened its new GMP manufacturing facility for transdermal drug delivery systems (TDS) and oral dispersible films (ODF) employing its RapidFilm technology.

05.26.11

Breaking News | Drug Development | Industry News

ICON Opens Translational Unit in Manchester

ICON has opened a purpose-built clinical pharmacology unit in the Central Manchester University Hospitals Foundation Trust (CMFT) campus in Manchester, UK.

07.16.10

Breaking News | Drug Development | Industry News

Azopharma Gains MHRA GMP Approval

Azopharma Drug Development Services has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for production of commercial product.

02.09.10

Breaking News | Industry News

Laureate Completes Drug Product for Trials

Laureate Pharma and Iconic Therapeutics, a developer of ophthalmic products, have completed the manufacture of the first GMP lot of hI-con1 recombinant Fc-Factor VII fusion protein for the potential treatment of macular degeneration and other diseases.

01.07.10

Breaking News | Promotions & Moves

SynCo Bio Partners

Raoul Fisser was named a QP to the Quality Affairs team of SynCo Bio Partners.

07.20.09

APIs | Breaking News | Clinical Trials | Industry News

Syntagon Renews GMP Accreditation

Syntagon has successfully renewed its GMP certification for the manufacture of clinical APIs

06.23.09

Breaking News | Industry News

Novozymes Recombumin Complies with USP-NF

Novozymes Biopharma's Recombumin and albucult products are the first to comply with the new excipient monograph standard for recombinant human albumin, published in the U.S. Pharmacopoeia - National Formulary (USP-NF). First

05.01.09

Breaking News | Industry News

Sinovac Gains GMP Certification for New Production Facility

Sinovac Biotech Ltd. has received GMP certification from the China�s State Food and Drug Administration (SFDA) for its filling and packaging production facility.

03.02.09

Risk Management