cGMP Manufacture

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 | 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

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

AGC Biologics Expands pDNA and mRNA Manufacturing Capacity

Expansion at Heidelberg site allows the CDMO to meet increasing demands of the cell and gene therapy market.

09.14.21

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

FUJIFILM Diosynth Biotechnologies, NeuExcell Enter Gene Therapy Mfg. Pact

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

09.13.21

Breaking News | cGMP Manufacture | Industry News

Cytiva Triples Single-Use Consumables Capacity in China

Three new manufacturing lines were successfully launched with an additional eight new lines planned to launch in 3Q22.

09.09.21

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

ADMA Biologics Gains FDA Approval for VanRx Aseptic Ops

Provides additional opportunity for contract manufacturing filling services and capabilities to third parties.

09.09.21

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

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

APIs | cGMP Manufacture | Solid Dosage/Creams/Ointments

Addressing Handling Challenges of Chemicals by Dry Granulation

Dry granulation can be a method to overcome caking issues and improve handling of buffers, salts and stabilizing chemicals during pharmaceutical manufacturing.

Sponsored released by MilliporeSigma 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 | cGMP Manufacture | Clinical Trial Materials | Formulation Development | Promotions & Moves

Avomeen Appoints Formulation and Clinical Trial Mfg. Director

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

08.31.21