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.
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.
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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.
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.