摘要
单克隆抗体药物在生物制药行业占有重要地位,是生物医药领域发展的主要方向。因此,单克隆抗体药物的质量控制已成为全球生物制药企业及法规机构关注的热点,对单克隆抗体药物精确表征的需求日益增加。毛细管电泳技术具有分离效率高、分析速度快、分离模式多、样品用量少等特点,已成为单克隆抗体药物分析和质量控制的重要手段。该文对毛细管凝胶电泳、毛细管等电聚焦、毛细管区带电泳等模式在单克隆抗体药物的纯度分析、等电点测定、电荷异质性分析和N-寡糖分析的应用进行综述,以期为国内单克隆抗体研究开发和生产的企事业单位提供技术参考。
Therapeutic monoclonal antibodies play an important role in biopharmaceuticals,and gradually become one of the main directions of the development of biological medicine.The quality control of monoclonal antibodies has also become the focus of global biopharma companies and regulatory agencies.Capillary electrophoresis has become an important tool in the analysis of monoclonal antibodies with multi-modes and high resolution.In this paper,we reviewed the application of capillary gel electrophoresis,capillary isoelectric focusing and capillary zone electrophoresis on the analysis of purity,isoelectric poin^^charge heterogeneity and^-glycan profiling of therapeutic monoclonal antibodies.
作者
陈泓序
屈锋
CHEN Hongxu;QU Feng(School of Life Science,Beijing Institute of Technology,Beijing 100081,China)
出处
《色谱》
CAS
CSCD
北大核心
2018年第3期195-208,共14页
Chinese Journal of Chromatography
基金
国家自然科学基金项目(21675012
21375008)~~
关键词
毛细管电泳
毛细管凝胶电泳
毛细管区带电泳
毛细管等电聚焦
单克隆抗体药物
纯度
电荷异质性
N-寡糖
综述
capillary electrophoresis(CE)
capillary gel electrophoresis(CGE)
capillary zone electrophoresis(CZE)
capillary isoelectric focusing(CIEF)
therapeutic monoclonal antibody(mAb)
purity
charge heterogeneity
^-glycan
review
