成像毛细管等电聚焦电泳分析糖蛋白类生物技术药物  

Analysis of glycoproteins by imaging capillary isoelectric focusing electrophoresis

作　　者：王丽[1] 周勇[1] 王军志[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国生物制品学杂志》2012年第8期1035-1038,共4页Chinese Journal of Biologicals

基　　金：国家"重大新药创制"科技重大专项项目(2009ZX09307-001)

摘　　要：目的建立成像毛细管等电聚焦电泳分析糖白蛋类生物技术药物的异构体和等电点的方法。方法应用优化的成像毛细管等电聚焦电泳技术,对3种糖蛋白类生物技术药物即聚乙二醇化重组人促红素(PEGlysated erythropoietin,PEG-EPO)、重组人组织型纤溶酶原激活剂TNK突变体(Recombinant human TNK mutant of tissue type plasminogen activator,rhTNK-tPA)和全人源化单抗A的异构体和等电点进行分析。结果采用优化的成像毛细管等电聚焦电泳技术,可较好地分析PEG-EPO、rhTNK-tPA和全人源化单抗A的等电点和异构体,该方法可靠、快速,具有较好的分离度和重现性。结论成像毛细管等电聚焦电泳技术可用于分析糖蛋白类生物技术药物的异构体和等电点,为保证糖蛋白类生物技术药物生产工艺的稳定性及质量控制提供了有效手段。Objective To develop an imaging capillary isoelectric focusing electrophoresis method for analysis of isomer and isoelectric point of glycoproteins.Methods Three glycoproteins,i.e.recombinant human PEGlysated erythropoietin（PEG-EPO）,recombinant human TNK mutant of tissue type plasminogen activator（rhTNF-tPA）and humanized monoclonal antibody（McAb）A were analyzed for isomers and isoelectric points by imaging capillary isoelectric focusing electrophoresis.Results The isoelectric points and isomers of PEG-EPO,rhTNF-tPA and humanized McAb A were effectively analyzed by the developed imaging capillary isoelectric focusing electrophoresis method.The method was reliable,rapid,and showed high resolution and reproducibility.Conclusion Imaging capillary isoelectric focusing electrophoresis method may be used for analysis of isomer and electric point of glycoproteins,which provides en effective tool for ensuring the stability of production procedure and quality control of glycoproteins.

关 键 词：等电聚焦 糖蛋白类 生物技术 电泳仪 

分 类 号：O657.8[理学—分析化学] R917[理学—化学]