摘要
工程细胞的单克隆源性是保证产品质量的重要因素之一,因此得到了越来越多的重视。当前,药物审评机构要求报批单位采用合适的实验手段证明所使用细胞的单克隆源性。综述通过介绍生产用工程细胞株单克隆的挑选过程及诸如有限稀释法、ClonePix、流式细胞术等常用方法,讨论如何确保工程细胞的单克隆源性,以及在生物药品生产过程中保证工程细胞单克隆源性的意义。
The monoclonality of recombinant cell lines is one of the important factors to ensure the quality of the product,so it has received more and more attention. Currently,some drug regulatory agencies require the application organization to demonstrate the monoclonality of the cells via appropriate experimental. The process and common methods (such as limiting dilution cloning,ClonePix,and fluorescent-activated cell sorting) for the clone selection of engineering cell lines for production were introduced. How to ensure the monoclonal of engineering cell,and the significance of engineering monoclonal in the production of the biological drug were discussed.
作者
江一帆
董静
魏敬双
JIANG Yi-fan;DONG Jing;WEI Jing-shuang(New Drug Research and Development Company Limited,North China Pharmaceutical Corporation,State Key Laboratory of Antibody Drug Development,Shijiazhuang 050015,Chi)
出处
《中国生物工程杂志》
CAS
CSCD
北大核心
2019年第4期101-105,共5页
China Biotechnology
基金
国家重大新药创制项目(2017ZX09306010)资助项目
关键词
工程细胞
单克隆源性
单克隆成像系统
有限稀释法
Engineering cell line
Monoclonality
Single-cell cloning imaging system
Limiting dilution method
