Manufacturing

Articles

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany. 

EMA Approves BioNTech’s COVID-19 Vaccine Manufacturing Site

The companies will aim to establish clinical and commercial supply agreements for Plus Therapeutics’ RNL-liposome drug product at the appropriate stage of development. 

Piramal Pharma Solutions to Provide Intermediate Drug Product Services to Plus Therapeutics 

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

Quotient Sciences Acquires CDMO Arcinova

Emergent will use its CDMO services to manufacture drug product batches to support the increased supply of the therapeutic candidate in anticipation of a potential emergency use authorization in the first quarter of 2021.

Emergent and Humanigen Form CDMO Compact for COVID-19 Therapeutic Candidate 

The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products and cGMP suites for early-phase cGMP manufacture.

Lonza to Expand Particle Engineering and Drug Product Capabilities at its Oregon Site

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

AstraZeneca and Samsung Biologics to Enter into Long-Term Supply Agreement for Up to $545.6 Million

The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes. 

Evonik Qualifies Filling Line for Parenteral Drug Products at its Alabama Facility 

The companies will utilize Avid’s upstream and downstream process development and drug substance manufacturing services in conjunction with Argonaut’s parenteral drug product fill-finish services for the delivery of CGMP parenteral drug products for use in clinical studies.

Avid and Argonaut Enter into Manufacturing Solutions Co-Marketing Agreement

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial. 

Novavax and Fujifilm Diosynth Biotechnologies Begin Manufacturing of COVID-19 Vaccine Candidate

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Filling and packaging of primary containers is a crucial piece of COVID-19 vaccine and therapeutic production.

Manufacturing, Drug Products