嵌合抗原受体T细胞产品生产系统的质量管理要点考量
The Consideration on Key Quality Management Points in Production System of CAR-T Products
颜若曦1
作者信息
- 1. 国家药品监督管理局食品药品审核查验中心,北京 100044
- 折叠
摘要
基于药品生产质量管理六大系统各自领域的要求,以及对己上市嵌合抗原受体T细胞(CAR-T)治疗产品主要生产工艺的分析,文章从CAR-T产品生产工艺质量管控、工艺验证与无菌工艺模拟试验、生产过程的污染与交叉污染控制、生产相关偏差及变更控制4个主要方面,分析与探讨了该类产品生产系统的特殊性及相应的质量管理要点,以期为先进治疗产品的持有人,特别是嵌合抗原受体T细胞产品的生产企业,进一步做好生产系统质量管理提供参考与借鉴,同时也为生产检查与质量审计提供思路.
Abstract
Based on the six major systems of drug production quality management and the analysis of the typical production processes of chimeric antigen receptor T cell(CAR-T)products,this review analyzes and discusses the particularity of the CAR-T product production system and the corresponding key quality management points from four main aspects,namely product production process quality control,process validation and aseptic processing simulation test,contamination and cross contamination control in the production process,and production related deviation and change control.This review provides some references to cell therapy product manufacturers especially CAR-T product manufacturers,to further improve production system quality management,and also provides a reference to production inspection and quality audit.
关键词
嵌合抗原受体T细胞(CAR-T)/细胞治疗/药品生产/质量管理/生物制品Key words
chimeric antigen receptor T cell(CAR-T)/cell therapy/medicine production/quality management/biological product引用本文复制引用
出版年
2024
NETL
NSTL
万方数据