聚乙二醇干扰素质量控制要点的探讨

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。

Discussion on main points of quality control of PEGlated interferons

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.