浅谈细胞产品开发用人诱导多能干细胞的建株要求  

Requirements on the establishment of human induced pluripotent stem cell lines used for the development of cell-derived therapeutic product

作　　者：张可华 纳涛 孟淑芳 ZHANGKe-hua;NA Tao;MENG Shu-fang(Cell Collection and Research Center,Institutes for Biological Products Control,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院生物制品检定所细胞资源保藏研究中心卫生部生物技术产品检定方法及其标准化重点实验室,北京100050

出　　处：《中国新药杂志》2022年第21期2101-2108,共8页Chinese Journal of New Drugs

基　　金：国家重点研发计划项目(2021YFA1101601);中国科学院战略性先导科技专项资助项目(XDA16040502)。

摘　　要：人诱导多能干细胞(human induced pluripotent stem cells, hiPSC)自从问世以来一直是干细胞和再生医学领域研究的热点,在国内干细胞产品临床转化研究高速发展的今天,随着hiPSC重编程技术、多能干细胞培养技术、干细胞诱导分化技术以及多能干细胞质量研究技术的不断深化,以hiPSC为基础开发的衍生产品开始从实验室逐渐走向临床产品开发及研究阶段。本文以基于hiPSC开发药品为出发点和思路,参考相关法规和指南,简述hiPSC的建株以及细胞株的质量要求,为开发以hiPSCs为基础的细胞治疗产品提供参考,以期在细胞产品开发的重要源头hiPSC细胞株尽可能满足药品监管的要求。Human induced pluripotent stem cells(hiPSC) is becoming the focus of stem cells and regenerative medicine research since their coming out. Today, with the rapid development of clinical transformation research of stem cells in China, hiPSC-derived cell therapeutic products gradually entered the clinical research stage, due to the development going deep in the technology of hiPSC reprogramming, cell culture and in vitro induced differentiation of pluripotent stem cells. According to the relevant regulations and guidelines on drug development, application of hiPSC cell lines for cell product development needs to follow the specific regulatory requirements. This paper briefly describes the requirement for establishment of hiPSC and the quality requirements of these cell lines, so as to provide reference for the development of hiPSC-derived cell therapeutic product.

关 键 词：细胞治疗 干细胞治疗 诱导多能干细胞 建株 质量控制 

分 类 号：R927[医药卫生—药学]