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Review
. 2020 Apr;57(2):33-38.
doi: 10.1053/j.seminhematol.2020.07.005. Epub 2020 Jul 27.

Improving CAR T cell therapy by optimizing critical quality attributes

Opal L Reddy, David F Stroncek, Sandhya R Panch
Review

Improving CAR T cell therapy by optimizing critical quality attributes

Opal L Reddy et al. Semin Hematol. 2020 Apr.

Abstract

Whether as a cure or bridge to transplant, chimeric antigen receptor (CAR)-T cell therapies have shown dramatic outcomes for the treatment of hematologic malignancies, and particularly relapsed/refractory B cell leukemia and lymphoma. However, these therapies are not effective for all patients, and are not without toxicities. The challenge now is to optimize these products and their manufacture. The manufacturing process is complex and subject to numerous variabilities at each step. These variabilities can affect the critical quality attributes of the final product, and this can ultimately impact clinical outcomes. This review will focus on optimizing the manufacturing variables that can impact the safety, purity, potency, consistency and durability of CAR-T cells.

Keywords: CAR-T cells; Critical quality attributes; Manufacturing.

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Conflict of interest statement

Conflicts of Interest None.

References

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