General considerations for quality control of recombinant protein PEGylation drug production

VernacularTitle:聚乙二醇化重组蛋白药物生产质量控制的一般考量
Author: Rong LIU ¹ ; Wu-Chao LI ; Jing-Feng HU ; Xiao-Hong LU ; Qiao-Qiao FENG
Author Information

1. 山东省食品药品审评查验中心,山东济南 250014
Keywords: polyethylene glycol; recombinant protein drugs; process control during production; dissociative polyethylene glycol; stability study
From: The Chinese Journal of Clinical Pharmacology 2024;40(4):629-632
CountryChina
Language:Chinese
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.