Practical considerations for sourcing clinical-grade human tissue to support development and production of emerging commercial cellular therapies

The rapid clinical advancement and commercial manufacturing of cellular therapeutics pose numerous industrial challenges for cell therapy development, process scalability, commercialization, and patient safety. Allogeneic cell therapy development, which involves sourcing healthy donor primary cells, such as bone marrow mesenchymal stromal cells (BM-MSC), hematopoietic stem and progenitor cells (HSPC), and T or NK cells for immunotherapy applications is especially challenging due to the rigorous process of screening and qualifying human tissue donors to prevent the transmission and spread of infectious diseases. Furthermore, it is a complex operation to ensure the maintenance of an active donor pool. The processes of procuring human tissue for clinical applications present many technical, ethical, and legal issues. Procurement and safety issues apply regardless of whether primary cell types are used directly to develop cell therapy formulations or utilized to engineer cells for clinical applications, for instance, human induced pluripotent stem cells (hiPSC). In this presentation, we provide a deeper insight into supply chain considerations for procuring and qualifying human donor tissues (including bone marrow and leukapheresis collections) as starting material for the generation of allogeneic cell therapy products. We focus on commercial vendor practices in compliance with the United States Food and Drug Administration (USFDA) 21 CFR part 1271 (HCT/P's) for donor identification, qualification, tissue procurement, and tissue shipping and handling to ensure the ethical sourcing and safety of these tissues for cell and gene therapy development.