Scalable Manufacturing of CAR T cells for Cancer Immunotherapy.

ABSTRACT: As of April 2021, there are five commercially available chimeric antigen receptor (CAR) T cell therapies for hematological malignancies. With the current transition of CAR T cell manufacturing from academia to industry, there is a shift toward Good Manufacturing Practice (GMP)-compliant closed and automated systems to ensure reproducibility and to meet the increased demand for cancer patients. In this review we describe current CAR T cells clinical manufacturing models and discuss emerging technological advances that embrace scaling and production optimization. We summarize measures being used to shorten CAR T-cell manufacturing times and highlight regulatory challenges to scaling production for clinical use.

Statement of significance ∣

As the demand for CAR T cell cancer therapy in

SUBMITTER: Abou-El-Enein M 

PROVIDER: S-EPMC8462122 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature