Regulatory Considerations for Decentralized Manufacturing of Personalized Cell Therapies: A Path Forward for Commercialization of Decentralized Manufacturing of CAR-T Cell Therapies

CAR-T cell therapies offer potentially curative treatment options for cancer patients who run out of available standard care such as chemotherapies and monoclonal antibody based targeted immunotherapies. Unprecedented efficacy data for leukemias and lymphomas have led to FDA approval several autologous CAR-T cell therapy for these B-cell malignancies including Kymriah®, Yescarta®, Tecartus®, and recently Breyanzi® with many on the horizon. In addition, two more autologous CAR-T cell therapies, ABECMA® of Celgene Corporation (Bristol-Myers Squibb) and CARVYKTI™ of Janssen Biotech, Inc. for relapsed or refractory multiple myeloma have been approved as well.