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
聚乙二醇化重组蛋白药物是由聚乙二醇(PEG)对重组蛋白药物修饰而成,在保留原型重组蛋白生物学活性前提下,克服原型蛋白体内代谢快、稳定性差、需多次给药等缺点,但也存在一定的特殊性,在对其质量控制的相关指导原则有限的情况下,通过对其生产用原材料控制、生产过程中工艺控制、中间产品及终产品的质量控制、稳定性研究等方面进行探讨,为其研究开发和生产质量控制提供一定参考.
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引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据