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.
Key Words
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Article info
Publication history
Published online: January 23, 2019
Accepted:
November 26,
2018
Received:
September 6,
2018
Identification
Copyright
© 2018 International Society for Cell and Gene Therapy. Published by Elsevier Inc. All rights reserved.
