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Quality considerations in early biopharma development

Presented at:

Pfenex’s Strategies for Accelerating Preclinical Development of Vaccines and Therapeutic Proteins seminar. 2013 Aug 20; Boston, MA.

Many decisions made early in development of a biopharmaceutical significantly impact the quality of the final product. Quality input should not be limited to those activities which are cGMP activities. Rather, quality considerations are needed throughout early development from cell line/strain development through final analytical and process qualification. This presentation will discuss how decisions made early in development of a protein, for example selection of the most appropriate cell line or strain, profoundly affect the overall development program.