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The inability of some ATMPs to be terminally sterilized and sterility tested within the allowable product stability time frame has increased aseptic assurance requirements for the entire manufacturing process. Compounded with time sensitive cryopreservation operations, ATMP manufacturing presents a unique set of challenges that need to be addressed during initial process equipment and facility design to avoid costly delays and operational risk. This presentation will focus on the unique challenges of ATMP commercial manufacturing, and the way unique containment and vial technologies can address some of these challenges.
