Shao Lipei, Zheng Yanyan, Somerville Robert P, Stroncek David F, Jin Ping
Center for Cellular Engineering, Clinical Center, National Institutes of Health, Bethesda, MD, United States.
Front Immunol. 2025 May 8;16:1597888. doi: 10.3389/fimmu.2025.1597888. eCollection 2025.
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.
本综述探讨了嵌合抗原受体（CAR）T细胞产品在特性和制造方面的最新进展。传统的效力测定方法是基于已确立的CAR T细胞功能而设计的。然而，创新工具和方法的出现揭示了与功能相关的更广泛的重要CAR T细胞特性。此外，随着制造策略的不断发展，传统的效力测定可能不再能完全体现这些产品的复杂性。因此，研究这些新出现的特性和制造方法，并考虑开发定制的效力测定方法以确保产品得到充分表征至关重要。
