The rapidly developing global cell therapy market poses numerous industry challenges for drug development, process scalability, commercialization, and patient safety. The processes of procuring human tissue for clinical applications are fraught with many technical, ethical, and legal issues. Allogeneic cell therapies involving primary cell types such as bone marrow mesenchymal stromal/stem cells (BM-MSCs), hematopoietic stem and progenitor cells (HSPCs), and T and NK cells for immunotherapy applications are especially challenging due to the vigorous process of screening and qualifying human tissue donors to avoid transmission of infectious disease combined with the need to ensure maintenance of an active donor pool.
The market trend of developing cell therapy treatments involving the use of MSCs, HSPCs, or immune cells (NK or T cells) requires additional screening and qualification of donor source material to address the risk of transmitting infectious disease agents, compliance with good tissue practices regarding the procurement of human tissues and the Health Insurance Portability and Accountability Act (HIPAA). Demand for such cell types is being driven by research and development of new allogeneic cell therapies, and development & validation of bioprocessing protocols for autologous cell & gene therapies.
Procurement of donated human tissue for clinical applications is complicated. In most cases partnering with an established supplier makes the most sense. Cell therapy developers, CDMOs, and other organizations must be vigilant in performing due diligence to select a supplier who has implemented appropriate operational controls and procedures that comply with regulatory requirements in multiple jurisdictions. The â€˜Top 10 Human Tissue Supplier Considerations for Allogeneic Cell Therapy Developmentâ€™ highlights some of the key considerations to keep in mind while evaluating human tissue suppliers for allogeneic cell therapy manufacturing.