Manufacturing

Articles

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.

Avantor to Increase Global Capacity for Single-Use Technologies

Samsung and TG Therapeutics have expanded their 2018 contract manufacturing deal for the supply of TG’s ublituximab, an investigational anti-CD20 monoclonal antibody. 

Samsung and TG Therapeutics to Expand mAb Manufacturing Collaboration 

Through the agreement, Lonza will use its fully integrated end-to-end program, Ibex Design, to manufacture cGMP material for the mAb while supporting the process from gene to IND.

Lonza Partners with aTyr Pharma for mAb Manufacturing

Eli Lilly has modified its purchase agreements with the US government for its emergency use authorized COVID-19 neutralizing antibody therapies, bamlanivimab and etesevimab, to be supplied and used together rather than individually.

Eli Lilly Modifies COVID-19 Purchase Agreement with the US Government

Sherri Dolan is a global technology consultant for Virus Clearance at Sartorius North America.

Paul Nolan is a process scientist at Sartorius in Glasgow, Scotland.

Stephen Carey is an analyst at Sartorius in Glasgow, Scotland.

Craig Quinney is a process scientist at Sartorius in Glasgow, Scotland.

Lorna Littlejohn, lorna.littlejohn@sartorius.com, is the manager of Confidence Virus Clearance Services at Sartorius in Glasgow, Scotland.

A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.

Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging Parvoviruses

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. 

Manufacturing, Monoclonal Antibodies