REVIEW article
Front. Immunol.
Sec. Alloimmunity and Transplantation
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1597888
This article is part of the Research TopicPotency Assays for Use in Manufacturing Cellular ImmunotherapiesView all articles
New insights on potency assays from recent advances and discoveries in CAR T-cell therapy
Provisionally accepted
- Center for Cellular Engineering, Clinical Center (NIH), Bethesda, Illinois, United States
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This review explores recent advances in the characteristics and manufacturing of CAR T-cell products. Traditional potency assays have been designed based on well-established CAR T-cell functionalities. However, the advent of innovative tools and methodologies has revealed a broader spectrum of important CAR T-cell characteristics that correlate with function. Furthermore, as manufacturing strategies continue to evolve, conventional potency assays may no longer fully capture the complexity of these products. Therefore, it is essential to examine these emerging characteristics and manufacturing approaches and consider the development of tailored potency assays to ensure products are fully characterized.
Keywords: Potency Assay Development, CAR T cell therapy, multi-omics, advances and discoveries, Quality control
Received: 21 Mar 2025; Accepted: 15 Apr 2025.
Copyright: © 2025 Shao, Zheng, Somerville, Stroncek and Jin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
David F. Stroncek, Center for Cellular Engineering, Clinical Center (NIH), Bethesda, 20892, Illinois, United States
Ping Jin, Center for Cellular Engineering, Clinical Center (NIH), Bethesda, 20892, Illinois, United States
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.