Manufacturing

Articles

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

Avid Bioservices Enters Manufacturing Agreement with Humanigen for Lenzilumab

The deal, which is set to close by the end of the first quarter of 2021, will provide Horizon with access to Viela’s rare disease medicine portfolio. 

Horizon Therapeutics to Acquire Viela Bio for $3 Billion

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 acquisition will give Sanofi full global rights to KY1005, Kymab’s fully human monoclonal antibody that binds to OX40-Ligand, giving it the potential to treat a variety of immune-mediated diseases and inflammatory disorders. 

Sanofi to Acquire Kymab for $1.4 Billion

Thomas Prouzeau is a purification process development scientist at Sanofi.

Jerome Pezzini, Jerome.pezzini@sanofi.com, is purification process and technology leader at Sanofi.

Benoit Mothes is purification process development group head at Sanofi.

The development of an innovative purification process simplifies downstream processing for biologics.



EASY: a Disruptive mAb Purification Process to Reduce Cost of Goods

Feliza Mirasol is the science editor for 

Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.

Updating Viral Clearance for New Biologic Modalities

The companies have formed a long-term manufacturing agreement to accelerate the global supply for Lilly’s COVID-19 antibody therapeutics.

Samsung Biologics and Lilly Partner to Accelerate Delivery of COVID-19 Antibody Therapeutics

When administered together in clinical trials, casirivimab and imdevimab were shown to lessen COVID-19 hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. 

FDA Issues EUA for COVID-19 Monoclonal Antibody Treatment

FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.

Lilly’s COVID-19 mAb Treatment Receives EUA

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

Manufacturing, Monoclonal Antibodies