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Review
. 2019 Mar;21(3):327-340.
doi: 10.1016/j.jcyt.2018.11.009. Epub 2019 Jan 23.

Manufacturing chimeric antigen receptor T cells: issues and challenges

Claire Roddie  1 , Maeve O'Reilly  2 , Juliana Dias Alves Pinto  3 , Ketki Vispute  3 , Mark Lowdell  3
Affiliations
Review

Manufacturing chimeric antigen receptor T cells: issues and challenges

Claire Roddie et al. Cytotherapy. 2019 Mar.

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.

Keywords: CliniMACS Prodigy; chimeric antigen receptor T cells; immunotherapy; lentiviral vectors.

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