基于蛋白质组学的单克隆抗体药物质谱分析

Mass spectrometry-based analysis of therapeutic monoclonal antibodies by proteomic approach

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。

Therapeutic monoclonal antibodies are the variants of IgG, most commonly based on human or mouse IgG. They provide a new platform to treat a wide range of diseases, such as cardiovascular diseases, inflammatory diseases, virus infection and cancers. 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 analysis methods of therapeutic monoclonal anti- bodies and their glycosylation and to study their pharmacokinetics and pharmacodynamics comprehensively. This review aims on the introduction of MS-based quantitative analysis methods of therapeutic monoclonal antibodies and their glycosylation.