真核细胞表达重组蛋白糖基化研究与评价  

Research and evaluation of glycosylation of recombinant products from eukaryotic cells

作　　者：韦薇[1] 项金忠[1] 罗建辉[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2014年第15期1743-1748,共6页Chinese Journal of New Drugs

摘　　要：糖基化是真核细胞表达重组蛋白常见的修饰形式,这种修饰形式影响到蛋白质的空间结构、生物活性、稳定性、溶解性、免疫原性等,进而影响到重组蛋白质在体内的动力学、代谢和组织分布。因而,真核细胞表达的生物制品药物的糖基化研究是产品结构研究和质量控制的重点关注课题。本文围绕真核细胞表达重组蛋白糖基化的影响因素、分析方法、质量控制与评价几个方面进行探讨。Glycosylation is one of most common and important modifications for recombinant protein products from eukaryotic cells, which may affect protein structure, biological activity, stability, dissolubility and immunogenicity as well as in vivo pharmacokinetics, metabolism and tissue distribution. Therefore, this is considered as a key factor regarding to the structure study and quality control during research and manufacture. In this article, we will focus on several aspects related to glycosylation study, such as mechanism, methods, quality control and evaluation.

关 键 词：糖基化 生物制品药物 研究与评价 

分 类 号：R95[医药卫生—药学]