Manufacturing chimeric antigen receptor T cells: issues and challenges.

Roddie, Claire; O'Reilly, Maeve; Dias Alves Pinto, Juliana; Vispute, Ketki; Lowdell, Mark · Cytotherapy · 2019

review · Level V

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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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