Quality by Design Implementation for Biologics: Lessons Learned from the FDA Pilot Program | AIChE

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Quality by Design Implementation for Biologics: Lessons Learned from the FDA Pilot Program

Authors 

Krummen, L. - Presenter, Genentech

Genentech and Roche entered 2 submissions in the FDA QbD Pilot Program for Biologics in 2009. Both submissions have now been approved. This talk will focus on what elements of Quality by Design were successfully implemented, and provide discussion of where remaining challenges exist to full realization of the Quality by Design concept.

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