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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蛋白类药物,为心血管疾病、自身免疫疾病、病毒感染及癌症等多种疾病的治疗提供了全新的途径。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,建立规范可靠的分析方法对单抗药物及其糖基化修饰进行定性、定量分析,并开展单抗药物的药代动力学及药效动力学研究具有十分重要的意义。本综述将简要介绍基于质谱技术的对单克隆抗体药物及其糖基化修饰的定性定量分析。
Monoclonal antibody drugs are a class of macromolecular protein drugs based on the structure of immunoglobulin G and provide a completely new approach to the treatment of many diseases such as cardiovascular diseases, autoimmune diseases, viral infections and cancers. The rapid development of monoclonal antibody drugs and its importance in the treatment of various diseases are increasingly prominent on the monoclonal antibody drug development and drug safety and so put forward higher requirements. Therefore, establishing a standardized and reliable analytical method for the qualitative and quantitative analysis of the monoclonal antibody drugs and their glycosylation modifications and carrying out pharmacokinetic and pharmacodynamic studies on the monoclonal antibody drugs is of great significance. This review summarizes qualitative and quantitative analyzes of monoclonal antibody drugs and their glycosylation modifications based on mass spectrometry.