摘要
嵌合抗原受体T细胞免疫疗法(CAR-T)作为肿瘤免疫治疗的突破性技术,通过基因修饰患者T细胞靶向杀伤肿瘤,展现出特殊疗效,为癌症患者带来了新希望。CAR-T治疗产品的质量与其临床疗效紧密相关,如何持续生产高质量的CAR-T治疗产品,已成为CAR-T细胞疗法实现广泛应用的关键。本文对自体CAR-T细胞产品生产过程的质量控制要点和产品的质量放行进行了综述,以期为更多CAR-T细胞产品的研究和应用提供参考。
Chimeric antigen receptor T-cell(CAR-T)therapy,as a revolutionary technology in tumor immunotherapy,achieves remarkable clinical efficacy by genetically modifying patient-derived T cells to specifically target and eliminate tumor cells,thereby offering new hope for cancer patients.The product quality of CAR-T therapeutics is critically correlated with their clinical efficacy,making the consistent production of high-quality CAR-T therapies a critical factor for widespread clinical application.This article reviews the key quality control parameters during autologous CAR-T cell manufacturing and product release testing,aiming to provide valuable references for advancing research and clinical implementation of CAR-T cell therapy.
作者
杨天一
穆菊
陈小春
唐浩
YANG Tianyi;MU Ju;CHEN Xiaochun;TANG Hao
出处
《中国医药生物技术》
2025年第S2期45-49,共5页
Chinese Medicinal Biotechnology
基金
国家重点研发计划重大慢性非传染性疾病防控研究重点专项(2019YFC1316301)。
关键词
嵌合抗原受体T细胞
质量控制
放行检测
chimeric antigen receptor T cell
quality control
release testing
