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.