Scalable Manufacturing of CAR T cells for Cancer Immunotherapy

Mohamed Abou-El-Enein, Magdi Elsallab, Steven A. Feldman, Andrew D. Fesnak, Helen E. Heslop, Peter Marks, Brian G. Till, Gerhard Bauer, Barbara Savoldo

Research output: Contribution to journalReview articlepeer-review

45 Scopus citations


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 increases, several closed and automated production platforms are being deployed, and others are in development.This review provides a critical appraisal of these technologies that can be leveraged to scale and optimize the production of next generation CAR T cells.

Original languageEnglish (US)
Pages (from-to)408-422
Number of pages15
JournalBlood cancer discovery
Issue number5
StatePublished - Sep 1 2021


  • Automation
  • CAR T cells
  • Clinical Production
  • Genetic Modification
  • GMP
  • Hematological Malignancies
  • Manufacturing
  • Scaling
  • Solid Tumors

ASJC Scopus subject areas

  • Medicine(all)


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