摘要
嵌合抗原受体T细胞(CAR-T)是一种新型的免疫细胞疗法,近几年在血液肿瘤治疗中取得了显著成效,同时在自身免疫性疾病以及实体肿瘤领域也取得了突破性进展。CAR-T细胞产品制备工艺复杂,其生产与质控流程的规范对保障治疗安全性与有效性至关重要。该文详细阐述了CAR-T细胞产品的生产工艺以及质量控制各环节需要充分考虑的技术要点与关键控制项目,包括生产物料、生产模式、生产设备和生产工艺,以及某些质量控制项目。此外,该文结合临床应用实践的经验,展望了未来CAR-T细胞产品技术发展路径和检测方法开发方向,旨为CAR-T细胞治疗领域从业同仁提供参考,共同推动该领域规范化发展。
CAR-T(chimeric antigen receptor T-cell)therapy is a novel form of immunotherapy with significant breakthroughs achieved in hematologic malignancies in recent years.Additionally,remarkable progress hasbeen made in the treatment of autoimmune diseases and solid tumors.The manufacturing process of CAR-T cellproducts is complex,and standardization of production and quality control processes is crucial to ensure the safetyand efficacy of the therapy.This article provides a detailed description of the production process for CAR-T cellproducts,including materials,manufacturing models,equipment,and process development,as well as quality control.Furthermore,based on clinical experience,the article discusses ongoing developments of CAR-T cell technologies and analysis methods,offering valuable insights for professionals in the field to promote the standardization ofthe development of CAR-T cell therapy.
作者
石琳
王永增
吕璐璐
SHI Lin;WANG Yongzeng;LÜLulu(Juventas Co.,Ltd.,Tianjin 300384,China)
出处
《中国细胞生物学学报》
2026年第1期195-207,共13页
Chinese Journal of Cell Biology
