重组蛋白药物电荷异质性的分析技术研究进展

Research Progress on Analytical Technique of Charge Heterogeneity of Recombinant Protein

电荷异质性是重组蛋白类药物的关键质量属性,对重组蛋白类药物的稳定性、溶解性、免疫原性、体内外生物学活性、药物动力学功能发挥具有重要的影响。选择一种灵敏度高、特异性强的电荷异质性检测分析方法,是控制和稳定重组蛋白药物生产质量的有效手段。该文章对电荷异质性的3种主要分析方法,即平板胶等电聚焦电泳、离子交换色谱、毛细管等电聚焦电泳等技术特点及近年的研究进展进行综述介绍。

Charge heterogeneity is a key quality attribute of recombinant protein drugs and has important influence on the stability,solubility,immunogenicity,biological activity in vitro and in vivo,and pharmacokinetic function of recombinant protein drugs. Selecting a high-sensitivity,high-specificity charge heterogeneity detection and analysis method is an effective means to control and stabilize the production quality of recombinant protein drugs. In this paper,the three main methods of charge heterogeneity are summarized,such as the electro-focusing electrophoresis of plate glue,ion exchange chromatography,and capillary isoelectric focusing electrophoresis,as well as the recent research progress.