Manufacturing of many ATMPs has been challenging due to issues such as small scales, lack of industrialized processes, and variation in processing technology. This is compounded by the need of many of these products to be aseptically processed from beginning to end as terminal sterilization is not possible. We will explore some examples of these challenges and identify approaches to successfully and consistently manufacture these products with minimized Sterility Assurance risk.
Manufacturing Challenges and Approaches for Aseptic Production of ATMPs,
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