基于双特异性抗体的全柱成像毛细管等电聚焦电泳方法开发策略  

Development Strategy of Whole-Column Imaging Detection for Capillary Isoelectric Focusing for Bispecific Antibodies

作　　者：刘闯 丁黎[1] LIU Chuang;DING Li(China Pharmaceutical University,Nanjing 211100,China)

机构地区：[1]中国药科大学,江苏南京211100

出　　处：《生物化工》2022年第6期147-152,共6页Biological Chemical Engineering

摘　　要：双特异性抗体是治疗性抗体领域的研究热点,抗体药物的质量控制也一直是生物制药企业和法规机构的关注重点。全柱成像毛细管等电聚焦电泳(Whole-Column Imaging Detection for Capillary Isoelectric Focusing,WCID-CIEF)是检测治疗性双特异性抗体等电点(Isoelectric point,p I)与电荷异质体的有效方法,但由于双特异性抗体分子本身的结构与理化性质复杂,通常需要针对特定分子进行方法开发或优化,以保证分析方法的专属性和良好的分离效果。本文基于双特异性抗体对全柱成像毛细管等电聚焦电泳的方法开发策略进行概述,包括添加剂、载体两性电解质种类与比例、占位剂、上样量、等电点标记物以及工作溶液稳定性等方面,以期为国内双特异性抗体研究与生产提供方法开发上的技术参考。Bispecific antibodies are research hotspots in the field of therapeutic antibody,and the quality control of antibody drugs has always been the focus of biopharmaceutical companies and regulatory agencies.Whole column imaged capillary isoelectric focusing(WCID-CIEF)is an effective method for detecting the isoelectric point(p I)and charge variants of therapeutic bispecific antibodies,but due to the complicated structure and physicochemical properties of bispecific antibody molecules themselves,method development or optimization is usually required for specific molecules to ensure the specificity and good separation effect of the analytical method.In this paper,the method development strategy of WCID-CIEF is summarized based on bispecific antibodies,including additives,types and proportions of carrier ampholytes,spacer agents,loading amount,pI markers and working solution stability,in order to provide a technical reference for the method development of bispecific antibody research and production in China.

关 键 词：双特异性抗体 全柱成像毛细管等点聚焦电泳 方法开发 

分 类 号：R917[医药卫生—药物分析学]