IL-17A单克隆抗体生物学活性检测方法的建立  

Establishment of Analytical Method for Biological Activity of IL-17A Monoclonal Antibody

作　　者：陈莹莹 于秀梅 张驰 杨丽君 吴洁 李宛宸 郭常闰 CHEN Yingying;YU Xiumei;ZHANG Chi;YANG Lijun;WU Jie;LI Wanchen;GUO Changrun(TongHua DongBao Pharmaceutical Co.,Ltd.,Tonghua 134000,China)

机构地区：[1]通化东宝药业股份有限公司,吉林通化134000

出　　处：《中国现代应用药学》2023年第6期808-811,共4页Chinese Journal of Modern Applied Pharmacy

基　　金：吉林省科技发展计划项目(20190304040YY)。

摘　　要：目的建立2种检测IL-17A单克隆抗体的生物学方法。方法(1)利用BIAcore T200系统,基于表面等离子共振技术(surface plasmob resonance,SPR)的分析方法检测IL-17A的生物学活性。(2)采用IL-6释放抑制法测定IL17-A单克隆抗体生物学活性。结果采用SPR法获得的偶联最佳pH值为5.0,动力学常数为0.10086 nmol·L^(-1),样品浓度为2.0625~33 nmol·L^(-1);IL-6释放抑制法检测的曲线拟合常数R2均满足>0.95,相对活性均在80%~125%,多次试验的RSD≤20%,满足重复性验证标准,符合要求。结论2种检测方法的结果均较好,可以有效地反映IL-17A的生物学活性,可以简单、快速用于检测IL^(-1)7A单克隆抗体生物活性。OBJECTIVE To establish two analytical method to determine the biological activity of IL-17A monoclonal antibody.METHODS①The biological activity of IL-17A was detected by BIAcore T200 analysis method based on surface plasma resonance(SPR).②Determine the biological activity of IL-17A monoclonal antibody by IL-6 release inhibition method.RESULTS The optimum pH value of coupling obtained by SPR method was 5.0,the kinetic constant was 0.10086 nmol·L^(−1),and the sample concentration was 2.0625−33 nmol·L^(−1).The curve fitting constants R2 detected by IL-6 release inhibition method met the requirements of>0.95,the relative activity was 80%−125%,and the RSD of multiple tests was≤20%,which met the repeatability verification standard and met the requirements.CONCLUSION The results of the two detection methods are good,which can effectively reflect the biological activity of IL-17A,and can be used to detect the biological activity of IL-17A monoclonal antibody simply and quickly.

关 键 词：IL-17A BIACORE 生物活性检测 单克隆抗体 

分 类 号：R917[医药卫生—药物分析学]