The FDA approval of CAR T cell therapy for ALL and NHL has led to a drastic increase of academic and industrial interest in this promising therapeutic modality. The success of this new therapy relies on reproducible manufacturing of high-quality clinical-grade CAR T cells. Over a decade ago we established a robust modular CAR-T production platform, which has allowed us to successfully manufacture hundreds of CAR-T cell products and supported twelve phase I/II CAR-T cell clinical trials at our center.
In order to further increase the throughput in CAR T cell production and to enable reproducible manufacturing between multiple point of care for multi-center trials, we evaluated the CliniMACS Prodigy system that incorporates all steps of the manufacturing process from T cell selection to the end process of CAR T cell formulation. Meanwhile, we also designed and tested novel CARs to improve the effector function and persistency of CAR-T cells. Using in vivo CAR-stress test in tumor-bearing mice, we found that the anti-tumor activity of CAR-T cells generated from the Prodigy platform or CAR-T cells with novel CAR designs displayed comparable or better antitumor activities, which correlated to their acquisition of effector/central memory T cell phenotype.