摘要
与普通干扰素相比,聚乙二醇干扰素具有半衰期长、给药次数少、血药浓度波动低等优势,上市产品日益增多。与普通干扰素结构上的差异决定了聚乙二醇干扰素具有独特的理化、生物学特性以及生产工艺,也决定了聚乙二醇干扰素质量控制的特殊性。重点探讨聚乙二醇干扰素质量控制中的主要难点,包括修饰度、修饰位点、相对分子质量等,为该品种的研发、生产及监管提供参考。
PEGlated interferons have many advantages compared with native interferons including longer ha/f-life, fewer intervals,higher stability of blood concentration and so on, and more and more related products are coming into the market. The differencewith native interferons in structure gives PEGlated interferons unique physicochemical and biological characteristics and productionprocesses, as well as its specificity in quality control. Here we focus on discussing the main difficulties in quality control of PEGlatedinterferons, including modification degree, modified site, molecular weight, and so on, providing reference for the research anddevelopment, manufacture, and supervision of related products.
出处
《药物评价研究》
CAS
2017年第9期1361-1364,共4页
Drug Evaluation Research
关键词
干扰素
聚乙二醇
聚乙二醇干扰素
修饰度
质量控制
interferon
polyethylene glycol
PEGlated interferon
modification degree
quality control
