Multicenter study on essentials for novel cellular therapy products manufacturing practices

At the frontier of Transfusion Medicine and Transplantation the field of Cellular Therapy is emerging. Most Novel cellular therapy products are produced under IND. The manufacturing protocols may vary depending on the type of cellular product (e.g. mesenchymal stromal cell, pancreatic islet, natural killer cells, or T regulatory lymphocytes…). Interestingly, the manufacturing practices may also vary with the institution under which the investigative protocol is filed. The purpose of this study is to uncover the variations in manufacturing practices for similar cellular therapy products across different Cellular Processing Laboratories in institutions worldwide. The results of this survey may allow the identification of the essentials of manufacturing practices to be recommended for specific cellular therapy products at different stages of manufacturing (i.e. collection, ex vivo manipulation or expansion, distribution, or preparation for infusion).

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