CAR-T Bioprocessing

Over the past 30 years, immunotherapy has grown from bench experiments to a viable clinical option in the battle against cancer with nearly 1000 currently registered clinical trials Ivica NA, Young CM. Tracking the CAR-T Revolution: Analysis of Clinical Trials of CAR-T and TCR-T Therapies for the Treatment of Cancer (1997-2020). Healthcare (Basel) 19;9(8):1062. In chimeric antigen receptor T-cell (CAR-T) immunotherapy, a patient’s own immune cells are engineered to express a CAR which recognizes cancer cells, expanded ex vivo and then introduced back into the patient, where the engineered cells will mount an immune response against the targeted cancer cells. Immunotherapy manufacturing requires careful consideration of the collection of immune cells from the patient, introduction of receptor into the cells, method of cell expansion, formulation for cryopreservation, and the unique supply chain that must connect clinics, hospitals, and manufacturers to supply individual patients. In this chapter, we provide a brief overview of the current clinical landscape, discuss current practices and key challenges at each manufacturing step using clinical examples where available, and highlight emerging technologies that may accelerate the progress of CAR-T therapies.