eBook: Allogeneic Cell Therapy — From Clinical Concept to Viable Product


Allogeneic cell therapy has become an entrenched concept in the biopharmaceutical industry. Despite clear successes for autologous therapies, especially those based on chimeric antigen receptor (CAR) T cells, cell-therapy companies have yet to devise scalable means for making drug products based on cellular material from and for individual patients. Thus, many cancer patients are left without access to potentially life-saving treatment. Products based on starting material from multiple healthy donors would seem to solve the scalability dilemma as well as concerns relating to process reproducibility and product quality. For decades, hematopoietic progenitor cell (HPC) transplantation represented the only viable approach, leaving allogeneic options for novel immune-cell therapies (often based on genetically engineered material) in the realm of clinical concept. However, cell-therapy developers are steadily gathering the process and product knowledge necessary to transition allogeneic candidates from early clinical studies to late-stage trials.

This eBook highlights recent industry efforts to bring a breadth of allogeneic cell therapies over the clinical hurdle. First, Diane McCarthy of the United States Pharmacopeia (USP) shines a spotlight on chemistry, manufacturing, and controls (CMC) considerations for cell and gene therapies (CGTs). Reporting on a recent meeting organized by the USP, US Food and Drug Administration, and Standards Coordinating Body, McCarthy shows how regulatory bodies and industry leaders are building alignment on quality expectations and best practices for CGT manufacture. Next, BPI’s managing editor speaks with Mark W. Frohlich (CEO of Indapta Therapeutics) about possibilities afforded by therapies based on natural killer (NK) cells. Frohlich calls particular attention to a naturally occurring NK subpopulation that could provide for scalable manufacture of allogeneic NK products. Tim Moore (executive vice president and chief technical officer of Allogene Therapeutics) underscores the critical need for allogeneic CAR-T products and describes promising clinical results from trailblazing candidates. Finally, Lorraine Borland and Julia Hengst from eBook sponsor Sartorius describe their company’s collaboration with Qasim Rafiq and other scientists at University College London (UCL) to establish scalable CAR-T production processes in stirred-tank bioreactors.    

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