Newsletter | March 26, 2020

03.26.20 -- 3 Biosimilar Questions Facing FDA, FTC, & Manufacturers

Featured Editorial
3 Pressing Questions From The FDA/FTC Biologics Competition Workshop
By Anna Rose Welch, editor, Biosimilar Development

After taking at least 20 pages of notes from the FDA/FTC biologics competition workshop, I’ve whittled my takeaways down to three overarching questions that provide necessary considerations and industry action steps moving forward. 

FDA FY2019 Warning Letter Trends: Focus On Drug Product Manufacturers
By Barbara Unger, Unger Consulting Inc.

This is the second article in a two-part series reviewing the FDA’s GMP drug warning letters from FY2019. In this part, we take a deeper dive into the types of drug product manufacturers that received warning letters, and their locations.


Industry Insights
Viral Clearance: 7 Chromatography Column Considerations
Article | By Linnea Troeng, GE Healthcare Life Sciences

Viral clearance studies are a critical part of the production of biologics. Here are seven things to consider while performing your next chromatography viral clearance study.

Manufacturing Of Sterile Aqueous Suspensions: A Primer
White Paper | By Omar A. Salman, Ph.D., Pfizer CentreOne Contract Manufacturing

Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing. 

Standing Out In The Crowded Biopharma CDMO Market
Webinar | ISR Reports

When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection they are able to communicate what is unique about their offering to the right audience at the right time. 

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