The rapid evolution and clinical success of T-cell immunotherapies is an exciting advance in the war on cancer. This treatment modality uses engineered cells from a patient’s own immune system to target and destroy cancerous cells. Chimeric antigen receptor T-cell (CAR-T) therapy is emerging as the most studied treatment in T-cell immunotherapy and is the basis for many ongoing clinical trials. FDA approval of the first two CAR-T therapies in 2017 provides a regulatory development framework, but optimization of CAR-T cell manufacturing processes will enable progression of additional such therapies through clinical trials to FDA approval.

For better understanding of the manufacturing difficulties, the authors analyzed technical and economic challenges encountered by CAR-T contract manufacturers and innovators. The analysis reveals that further refinement and implementation of an automated closed system could facilitate expansion of CAR-T therapies into routine cancer treatment.

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