Glycan analysis of therapeutic glycoproteins

作     者：Zhang, Lei Luo, Shen Zhang, Baolin 

作者机构：US FDA Off Biotechnol Prod Ctr Drug Evaluat & Res Silver Spring MD USA 

出 版 物：《MABS》 (单克隆抗体)

年 卷 期：2016年第8卷第2期

页      面：205-215页

核心收录：

学科分类：1001[医学-基础医学(可授医学、理学学位)] 10[医学] 

基　　金：Intramural FDA HHS [FD999999] Funding Source: Medline 

主　　题：lectin microarray Analytics glycosylation biopharmaceuticals monoclonal antibodies therapeutic proteins glycan profiling 

摘      要：Therapeutic monoclonal antibodies (mAbs) are glycoproteins produced by living cell systems. The glycan moieties attached to the proteins can directly affect protein stability, bioactivity, and immunogenicity. Therefore, glycan variants of a glycoprotein product must be adequately analyzed and controlled to ensure product quality. However, the inherent complexity of protein glycosylation poses a daunting analytical challenge. This review provides an update of recent advances in glycan analysis, including the potential utility of lectin-based microarray for high throughput glycan profiling. Emphasis is placed on comparison of the major types of analytics for use in determining unique glycan features such as glycosylation site, glycan structure, and content.