抗EGFR单克隆抗体药物纯度分析  

The analysis of purity of anti-EGFR monoclonal antibody

作　　者：裴朝玉[1] 杨丽霞[1] 

机构地区：[1]周口师范学院化学系,河南周口466001

出　　处：《周口师范学院学报》2013年第2期56-58,共3页Journal of Zhoukou Normal University

基　　金：河南省教育厅自然科学研究项目(No.2011B150041)

摘　　要：应用体积排阻色谱法、非还原SDS-PAGE法、离子交换色谱法分析抗EGFR单克隆抗体纯度.结果表明:三种分析方法分析抗EGFR单克隆抗体纯度表现出明显差异,体积排阻色谱法检测出多聚体含量、非还原SDS-PAGE法检测出降解片段的含量、离子交换色谱法检测出多个电荷异构体.基于单克隆抗体结构的多样性,有必要开发多种分析方法监控单克隆抗体的纯度.The purity of anti- EGFR monoclonal antibody was analyzed by such analysis methods as size exclusion chro- matography（SEC）, non- reducing SDS -PAGE and ion exchange chromatography. Significant difference was observed in pu- rity analysis, which was showed that aggregates could be detected by SEC, degradation fragment was found by non- reduc- ing SDS- PAGE, and several charge isoforms were detected by ion exchange chromatography. It is essential to apply many analysis methods to the purity of monoclonal antibody due to its structure diversity.

关 键 词：抗EGFR单克隆抗体 体积排阻色谱法 离子交换色谱法 非还原SDS—PAGE 电荷异构体 

分 类 号：R917[医药卫生—药物分析学]