国产芯片毛细管电泳仪性能研究及单克隆抗体分析应用  

Performance and Application of Monoclonal Antibodies Analysis of Domestic Chip Capillary Electrophoresis Instrument

作　　者：沈泓 冯一鸣 卜晨 孙晗 秦奕辉 阮昊 王艳君 陈万勤 潘攀 张愫 李志豪 彭姣 何凯伦 SHEN Hong;FENG Yiming;BU Chen;SUN Han;QIN Yihui;RUAN Hao;WANG Yanjun;CHEN Wanqin;PAN Pan;ZHANG Su;LI Zhihao;PENG Jiao;HE Kailun(Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;Focused Photonics(Hangzhou)Inc.,Hangzhou 310056,China;TJ Biopharma(Hangzhou)Co.,Ltd.,Hangzhou 310018,China;Zhejiang University of Technology,Hangzhou 310014,China)

机构地区：[1]浙江省食品药品检验研究院,杭州310052 [2]聚光科技(杭州)股份有限公司,杭州310056 [3]天境生物科技(杭州)有限公司,杭州310018 [4]浙江工业大学,杭州310014

出　　处：《中国现代应用药学》2024年第18期2563-2571,共9页Chinese Journal of Modern Applied Pharmacy

基　　金：浙江省“尖兵”“领雁”研发攻关计划(2023C030256);浙江省“尖兵”研发攻关计划(2022C10140);浙江省药监局科技计划(2023016)。

摘　　要：目的 以PA800 Plus毛细管电泳仪为参照对象,对采用MCE-SDS原理的国内自主研发的芯片毛细管电泳仪(MCE-100)进行了性能参数比对研究及还原性单克隆抗体样品检测应用。方法 研究初期制备了人白蛋白和转铁蛋白参考品混合液作为非单抗类蛋白供试品,分别从线性、灵敏度、精密度等方面对国产芯片毛细管电泳仪进行了系统性考察,并进一步研究了国产芯片毛细管电泳仪在还原性单克隆抗体蛋白样品检测的应用,同时进行了方法学验证。结果 该国产芯片毛细管电泳仪具有良好的系统性能,能够快速、高通量地完成蛋白样品的检测分析。结论 MCE-100国产芯片毛细管电泳仪具备蛋白分析检测能力,可用于一般蛋白样品及单克隆抗体药物的纯度分析。OBJECTIVE To compare the performance parameters of the chip capillary electrophoresis instrument independently developed in China base on MCE-SDS with the PA800 Plus capillary electrophoresis instrument,and the application of reducing monoclonal antibody sample detection with domestic capillary electrophoresis.METHODS A systematic examination of the domestic chip capillary electrophoresis apparatus in terms of linearity,sensitivity and precision using the mixture of human serum albumin and transferrin.Meanwhile,the application of domestic capillary electrophoresis instrumentation for the detection of reduced monoclonal antibody protein samples was further investigated,along with methodological validation.RESULTS The results showed that this domestic chip capillary electrophoresis instrument had good system performance and could complete the detection and analysis of protein samples quickly and in high throughput.CONCLUSION This domestic chip capillary electrophoresis instrument has the ability of protein analysis and detection,and can be used for the purity analysis of general protein samples and monoclonal antibody drugs.

关 键 词：国产化替代 毛细管电泳仪 MCE-SDS 单克隆抗体 方法验证 

分 类 号：R945[医药卫生—微生物与生化药学]