刘芬 孙程洁 王冲

    摘 要 嵌合抗原受体T细胞(chimeric antigen receptor T cell， CAR-T)治疗产品的上市为恶性肿瘤治疗提供了新手段。能否持续生产高质量的CAR-T治疗产品对CAR-T治疗的成功至关重要。本文论述CAR-T治疗产品生产工艺控制及质量管理中应予以特别关注的几个要点，以期为该类产品质量的持续改进和监管机构的监管提供参考。

    关键词 嵌合抗原受体T细胞 细胞治疗产品 生产工艺 质量管理

    中图分类号：R951； R979.19 文献标志码：C 文章编号：1006-1533(2022)11-0008-03

    引用本文 刘芬， 孙程洁， 王冲. 嵌合抗原受体T细胞治疗产品生产工艺控制及质量管理关注点探讨[J]. 上海医药， 2022， 43(11)： 8-10； 63.

    Discussion on concerns of manufacturing process and quality management of chimeric antigen receptor T cell therapy products

    LIU Fen， SUN Chengjie， WANG Chong

    (Shanghai Center for Drug Evaluation and Inspection， Shanghai 201210， China)

    ABSTRACT Chimeric antigen receptor T cell (CAR-T) therapy provides a novel approach for the treatment of malignant tumors. Whether or not high-quality CAR-T therapeutic products can be sustainably produced is critical to the success of this therapy. This article discusses several points that special attention should be paid in the production process control and quality management of CAR-T therapeutic products， so as to provide reference for the continuous improvement of the quality of such products and the supervision of regulatory agencies. ......