與普通干擾素相比，聚乙二醇干擾素具有半衰期長、給藥次數(shù)少、血藥濃度波動低等優(yōu)勢，上市產(chǎn)品日益增多。與普通干擾素結(jié)構(gòu)上的差異決定了聚乙二醇干擾素具有獨特的理化、生物學特性以及生產(chǎn)工藝，也決定了聚乙二醇干擾素質(zhì)量控制的特殊性。重點探討聚乙二醇干擾素質(zhì)量控制中的主要難點，包括修飾度、修飾位點、相對分子質(zhì)量等，為該品種的研發(fā)、生產(chǎn)及監(jiān)管提供參考。

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.