在配体结合分析中采用单孔分析方法的回顾性研究  

A Retrospective Study on the Application of Singlicate Analysis Method in Ligand Binding Assays

作　　者：李帅 梅妮 张皖晋 李刚 吴浩 陈桂良 魏春敏 王莹 LI Shuai;MEI Ni;ZHANG Wanjin;LI Gang;WU Hao;CHEN Guiliang;WEI Chunmin;WANG Ying(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201210;Center for Drug Evaluation,NMPA,Beijing 100022;Center for Food and Drug Inspection of NMPA,Beijing 100044)

机构地区：[1]上海药品审评核查中心,上海201210 [2]国家药品监督管理局药品审评中心,北京100022 [3]国家药品监督管理局食品药品审核查验中心,北京100044

出　　处：《中国医药工业杂志》2023年第9期1360-1366,共7页Chinese Journal of Pharmaceuticals

摘　　要：该研究回顾性分析了8个配体结合分析项目(5个验证项目和3个样品分析项目)。这些项目涉及3个不同的分析平台[ELISA、单分子免疫阵列(Simoa)和电化学发光免疫分析技术(MSD)]和3种不同的分子类型(单克隆抗体、蛋白类生物标志物和中和抗体药物),对这些项目数据分别采用单孔分析和复孔分析的方式进行检测。分析结果显示,在孔间变异较小(<5%)的情况下,单孔分析和复孔分析方式所得结果之间存在良好的相关性,并且计算得到的主要药动学参数(AUC和c_(max))之间没有显著性差异,可以将单孔分析替代复孔分析应用于上述分析平台。This study aimed to retrospectively analyze eight ligand binding assay projects,including five validations and three sample analyses.These projects involved three analysis platforms[ELISA,single molecule array(Simoa),and meso scale discovery(MSD)]and three distinct molecular types(monoclonal antibodies,protein biomarkers,and neutralizing antibodies).The data from above projects were respectively analyzed by singlicate-and replicate-based analysis.The analysis results revealed a strong correlation between singlicate-and duplicate-based analysis when the inter well variability was below 5%.Additionally,there were no significant differences in the calculation results of the key pharmacokinetic parameters(AUC and c_(max))between singlicate-and duplicate-based analysis.Thus,the result suggest that singlicate-base analysis can be a viable alternative to duplicate-based analysis on the aforementioned analysis platforms.

关 键 词：单孔分析 复孔分析 配体结合分析 生物样品分析 

分 类 号：R917[医药卫生—药物分析学]