2024 | Melanie Ayala Ceja, Mobina Khericha, Caitlin M. Harris, Cristina Puig-Saus, Yvonne Y. Chen
Chimeric antigen receptor (CAR)-T cell therapies have shown significant potential in treating B-cell malignancies and other indications such as autoimmune diseases. The success of these therapies depends on effective CAR-T cell manufacturing, which impacts product safety, efficacy, and patient accessibility. This review discusses the major process parameters in autologous CAR-T cell manufacturing, including the choice of starting cell population, T-cell activation methods, CAR transgene introduction, ex vivo cell expansion, and product release testing. It also explores next-generation strategies such as accelerated cell manufacturing, process automation, and in vivo cell manufacturing to address challenges in current manufacturing processes. These advancements aim to improve the efficiency, cost-effectiveness, and accessibility of CAR-T cell therapies, ultimately enhancing patient outcomes.Chimeric antigen receptor (CAR)-T cell therapies have shown significant potential in treating B-cell malignancies and other indications such as autoimmune diseases. The success of these therapies depends on effective CAR-T cell manufacturing, which impacts product safety, efficacy, and patient accessibility. This review discusses the major process parameters in autologous CAR-T cell manufacturing, including the choice of starting cell population, T-cell activation methods, CAR transgene introduction, ex vivo cell expansion, and product release testing. It also explores next-generation strategies such as accelerated cell manufacturing, process automation, and in vivo cell manufacturing to address challenges in current manufacturing processes. These advancements aim to improve the efficiency, cost-effectiveness, and accessibility of CAR-T cell therapies, ultimately enhancing patient outcomes.