分析化学2014，Vol.42Issue(3)：337-342,6.DOI:10.3724/SP.J.1096.2014.30623
两种重组抗CD20人源化单克隆抗体定量分析方法的比较及其在药代动力学研究中的应用
Comparison of Two Quantitative Assays for Determination of Rh-anti-CD20 zumab and Their Application to Pharmacokinetic Study
摘要
Abstract
An enzyme linked immunosorbent assay ( ELISA ) and a flow cytometry assay ( FCA ) based on Wil2-S cells were developed and systematically compared for quantification of recombinant anti-CD20 humanized monoclonal antibody ( rh-anti-CD20zumab) in biological matrix. The specificity, precision and accuracy of each method at correspondingly different linear range showed good results. For ELISA, the precisions of intra-day and inter-day were both <19 . 5%, the relative error was from-18 . 2% to 17 . 6%;For FCA, the precisions of intra-day and inter-day were both <19. 0%, the relative error was from -18. 9% to 18. 4%. The sensitivity of ELISA was significantly higher than that of FCA. The quantitative ranges of ELISA and FCA methods were 0. 04-5. 0 mg/L and 3. 1-200 mg/L, respectively. The concentrations in serum samples and pharmacokinetics analysis were determined by both of two methods after vein drip administration of rh-anti-CD20zumab in rhesus monkeys. Pharmacokinetics data showed that there was excellent consistency between results obtained by two methods at the given dose. We believe that the novel FCA with high speed and high sensitivity can be used to perform PK and PD study of cell surface antigen-targeted antibody derivatives.关键词
抗CD20单克隆抗体/人源化/ELISA/流式细胞术/药代动力学Key words
Anti-CD20 monoclonal antibody/Humanized/Enzyme linked immunosorbent assay/Flow cytometry assay/Pharmacokinetics引用本文复制引用
邓承莲,邹佳,欧伦,董立厚,宋海峰..两种重组抗CD20人源化单克隆抗体定量分析方法的比较及其在药代动力学研究中的应用[J].分析化学,2014,42(3):337-342,6.基金项目
本研究系国家“重大新药创制”科技重大专项十一五、十二五“临床前药代动力学技术平台”基金(No.2009ZX09304-004,2012ZX09301003-001-007)资助项目 （No.2009ZX09304-004,2012ZX09301003-001-007）
