cGMP Manufacture

cGMP Manufacture | Chemistry

AMRI

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Valerie Keays, Marketing Communications Manager 06.17.21

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

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

Revolo and Northway Biotech Enter Manufacturing Partnership

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

06.11.21

WuXi XDC and LegoChem Ink ADC Agreement

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

06.11.21

Vibalogics Expands Manufacturing Capacity

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

06.11.21

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

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

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

06.10.21

Portonbio Enters CAR-T Partnership with KAEDI

CDMO will provide KAEDI with CMC services for multiple projects.

Tim Wright, Editor, Contract Pharma 06.07.21

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

Fusion to Build Radiopharma Manufacturing Facility

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

Tim Wright, Editor, Contract Pharma 06.07.21

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

VIVEbiotech Launches Lentiviral Vectors Mfg. Plant

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

Kristin Brooks 06.04.21

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

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

Lonza, Moderna Expand COVID Vax Mfg. Alliance

Lonza to support the manufacture of up to an additional 300 million doses per year with install of a new manufacturing line at The Netherlands site.

Kristin Brooks 06.02.21

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

Breaking News | cGMP Manufacture | Industry News | Information Technology

Novatek Requalified as Supplier for Boehringer Aseptic Mfg. Facilities

Novatek's regulatory compliant quality solutions used at Boehringer for human pharma, animal health and biopharmaceutical sterile manufacturing sites.

Kristin Brooks 05.26.21

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

Cambrex Adds Kilogram-Scale Mfg. Capabilities at Estonia

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

Kristin Brooks 05.26.21

Avid Bioservices to Manufacture Zynlonta for ADC Therapeutics

Zynlonta is an antibody drug conjugate approved for cancer treatment.

Charles Sternberg, Assistant Editor 05.25.21

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

CanSino Biologics Gets OGYÉI GMP Certificate for COVID Vax

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

Kristin Brooks 05.24.21

Moderna, Samsung Biologics Ink COVID Vax Mfg. and Supply Pact

Samsung Biologics will provide large scale, commercial fill-finish manufacturing for mRNA-1273 from its facilities in Incheon, South Korea.

Kristin Brooks 05.24.21

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

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