Discussion on main points of quality control of PEGlated interferons
10.7501/j.issn.1674-6376.2017.09.033
- VernacularTitle:聚乙二醇干扰素质量控制要点的探讨
- Author:
ning De PEI
1
;
Ying GUO
;
ming Chun RAO
Author Information
1. 中国食品药品检定研究院重组药物室
- Keywords:
interferon;
polyethylene glycol;
PEGlated interferon;
modification degree;
quality control
- From:
Drug Evaluation Research
2017;40(9):1361-1364
- CountryChina
- Language:Chinese
-
Abstract:
PEGlated interferons have many advantages compared with native interferons including longer half-life,fewer intervals,higher stability of blood concentration and so on,and more and more related products are coming into the market.The difference with native interferons in structure gives PEGlated interferons unique physicochemical and biological characteristics and production processes,as well as its specificity in quality control.Here we focus on discussing the main difficulties in quality control of PEGlated interferons,including modification degree,modified site,molecular weight,and so on,providing reference for the research and development,manufacture,and supervision of related products.
