中国临床药理学杂志2024，Vol.40Issue(4)：629-632,4.DOI:10.13699/j.cnki.1001-6821.2024.04.032
聚乙二醇化重组蛋白药物生产质量控制的一般考量
General considerations for quality control of recombinant protein PEGylation drug production
刘荣 1李武超 2胡敬峰 1吕小红 1冯巧巧1
作者信息
- 1. 山东省食品药品审评查验中心,山东济南 250014
- 2. 国家药品监督管理局食品药品审核查验中心,北京 100076
- 折叠
摘要
Abstract
Polyethylene glycosylation(PEGylation)of recombinant protein drugs are modified by PEG.To preserve the biological activity of the prototype recombinant protein,it overcomes the drawbacks of fast metabolism,poor stability,and the need for multiple doses of the prototype protein in vivo,but also has specificity.In the case of limited guidelines for quality control,discussions are conducted on the control of raw materials used in production,process control during production,quality control of intermediate and final products,stability research,and other aspects,in order to provide reference for the control and development of recombinant protein PEGylation drugs.关键词
聚乙二醇/重组蛋白药物/过程控制/游离聚乙二醇/稳定性研究Key words
polyethylene glycol/recombinant protein drugs/process control during production/dissociative polyethylene glycol/stability study分类
医药卫生引用本文复制引用
刘荣,李武超,胡敬峰,吕小红,冯巧巧..聚乙二醇化重组蛋白药物生产质量控制的一般考量[J].中国临床药理学杂志,2024,40(4):629-632,4.
