徐刚领, 韦薇, 罗建辉, 白玉. 单抗药物N-糖基化修饰对结构功能影响及相关药学问题考量J. 药学学报, 2020,55(6): 1345-1350. doi: 10.16438/j.0513-4870.2019-1064
引用本文: 徐刚领, 韦薇, 罗建辉, 白玉. 单抗药物N-糖基化修饰对结构功能影响及相关药学问题考量J. 药学学报, 2020,55(6): 1345-1350. doi: 10.16438/j.0513-4870.2019-1064
XU Gang-ling, WEI Wei, LUO Jian-hui, BAI Yu. Impact of glycosylation on monoclonal antibody structure, function and related CMC regulatory considerationsJ. Acta Pharmaceutica Sinica, 2020,55(6): 1345-1350. doi: 10.16438/j.0513-4870.2019-1064
Citation: XU Gang-ling, WEI Wei, LUO Jian-hui, BAI Yu. Impact of glycosylation on monoclonal antibody structure, function and related CMC regulatory considerationsJ. Acta Pharmaceutica Sinica, 2020,55(6): 1345-1350. doi: 10.16438/j.0513-4870.2019-1064

单抗药物N-糖基化修饰对结构功能影响及相关药学问题考量

Impact of glycosylation on monoclonal antibody structure, function and related CMC regulatory considerations

  • 摘要: 单克隆抗体Fc段上通常存在两个N-糖修饰,对单抗的结构和功能具有重要影响。本文对各种糖型与单抗结构和功能的关系以及糖基化分析研究方法进行综述,并讨论了糖型在质量标准建立和提高、工艺变更前后糖型可比性评价和单抗生物类似药糖型的相似性评价中的药学考量。

     

    Abstract: Fc region of a monoclonal antibody usually contains two N-glycosylation, which have a profound influence on its structure and function. Here, we review the relationship between various glycoforms and their impact on structure and function of monoclonal antibodies, along with the technologies for glycosylation analysis. In addition, some related Chemistry, Manufacturing and Controls (CMC) regulatory considerations are also discussed, such as specification improvement, biosimilarity assessment as well as comparability of pre- and post-process changes in glycosylation.

     

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