Important considerations should be taken in the selection of a manufacturer to source Leukocytes/Cellular starting materials and related ancillary products. Manufacturers must be GMP/GTP compliant and capable of sourcing RUO and GMP materials to allow an efficient path for ATMPs to move through the clinical pipeline and be approved for commercial use. The FDA has promulgated a particular set of regulations, referred to as GTPs, that specifically address the need to procure and process tissues in a manner that avoids transmission of a communicable disease. GTPs and GMPs must be followed for cell-based advanced therapies or tissue-based therapy products. Download this presentation to learn more.
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