Centralized vs Decentralized Manufacturing of Personalized Cell Therapies: CAR-T cell Product Manufacture, Quality and Release

Gene modified cellular products, such as CAR-T cells, are increasingly becoming critical medicines in the arsenal used for the treatment of serious diseases. Several curative therapies have been approved by the FDA for the treatment of Leukemia and Lymphoma, including Kymriah®, Yescarta®, Tecartus®, and recently Breyanzi® with many in the pipeline. One of the most important aspects for successful implementation of CAR-T cell therapy is product quality and release. While the types of quality attributes are similar for all CAR-T cell products, their mode of manufacturing and release differs when comparing centralized and decentralized manufacturing paradigms.