Strategies for manufacturing cell therapy products aligned with patient needs.

Chimeric Antigen Receptor T cell (CAR-T) therapies have demonstrated promising clinical response rates for patients with hematological malignancies. CAR-T cells are generated by bioengineering patient T cells to express CAR proteins that can specifically target tumor antigens. For CAR-T therapy to be effective in solid tumors, several factors including trafficking, activation, expansion, and persistence are important considerations in hostile tumor microenvironment (TME). Despite significant advances in CAR-T therapies, clinical success in solid tumor indications has been limited. The complex processes involved in CAR-T manufacturing and quality control (QC) contribute to high cost of these therapies, creating barriers to widespread adoption. The processes involved are not uniformly standardized and may require numerous manual handling steps. This chapter details strategies to overcome barriers to broad CAR-T application and reviews current production processes used for CAR-T manufacturing. Emphasis is placed on reproducibility, manufacturing costs, and product release testing. Implementing new processing alternatives and innovative CAR-T designs, along with further innovation and efficiencies will be key to more consistent CAR-T cell therapy success.