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Comparability Protocol Example Form

Comparability Protocol Example Form

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thank you for that introduction it's a pleasure to be part of this meeting in the office of biotechnology products or op we're focused on supporting quality aspects of drugs specifically biotechnology products our goal is to ensure release of consistently safe and potent protein products and to uphold standards of purity I'll begin by stating that this presentation reflects our experiences as reviewers and should not be used in place of regulations published FDA guidance or discussions with the agency for the first part of this talk I will focus on review principles for biotechnology products and then my colleague Dr Kristen nickens will discuss Communications with the agency we're beginning with the statement know your product with an emphasis on your and that's because one of the themes here is that all of these products are unique with their own considerations appropriate control relies on an overall strategy Guided by product understanding fo

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