单克隆抗体药物糖基化修饰分析研究进展

单克隆抗体药物是一类以免疫球蛋白G的结构为基础的大分子糖蛋白药物，为癌症、自身免疫疾病以及病毒感染等多种疾病的治疗提供了全新的途径。单抗药物的糖基化修饰类型及水平对其稳定性、清除率、免疫原性、抗体依赖细胞毒性及补体依赖细胞毒性等都有一定的影响。单抗药物的迅速发展及其在多种疾病治疗中日益凸显的重要性都对单抗药物的研发及用药安全等方面提出了更高的要求。因此，建立规范可靠的单抗药物糖基化修饰分析方法有着十分重要的意义。该综述将简要介绍单克隆抗体药物糖基化修饰及相关的定性、定量分析方法。

Recent advances on the analysis of glycosylation of therapeutic monoclonal antibodies

Therapeutic monoclonal antibodies are the variants of immunoglobulin G, most commonly based on human or mouse immunoglobulin G. They provide a new platform to treat a wide range of diseases, such as cancers, inflammatory diseases and virus infection. A lot of studies demonstrated that N-glycosylation of therapeutic monoclonal antibodies has effects on their stability, solubility, and clearance as well as immunogenicity, antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. The fast development and increasing importance of their therapeutic action highlight the importance of drug research and medication security. Therefore, it has great significance to establish reliable qualitative and quantitative analytical methods of glycosylation of therapeutic monoclonal antibodies. This review introduces the glycosylation of therapeutic monoclonal antibodies and the method developments for qualitative and quantitative analyses of their glycosylation.