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Updated: Jan 30, 2026

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
Published on: August 18, 2023
Manufacturing chimeric antigen receptor T cells: issues and challenges
Claire Roddie1, Maeve O'Reilly1, Juliana Dias Alves Pinto2
1Research Department of Haematology, University College London, London, UK; Department of Haematology, University College London Hospitals National Health Service (NHS) Foundation Trust, London.
Abstract:
Clinical trials of adoptively transferred CD19 chimeric antigen receptor (CAR) T cells have delivered unprecedented responses in patients with relapsed refractory B-cell malignancy. These results have prompted Food and Drug Administration (FDA) approval of two CAR T-cell products in this high-risk patient population. The widening range of indications for CAR T-cell therapy and increasing patient numbers present a significant logistical challenge to manufacturers aiming for reproducible delivery systems for high-quality clinical CAR T-cell products. This review discusses current and novel CAR T-cell processing methodologies and the quality control systems needed to meet the increasing clinical demand for these exciting new therapies.
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