医药导报2023，Vol.42Issue(12)：1791-1795,5.DOI:10.3870/j.issn.1004-0781.2023.12.008
流式细胞术测定食蟹猴血清中抗间充质干细胞抗药抗体及其应用
Determination of Anti-Mesenchymal Stem Cell Antibody in Cynomolgus Monkey Serum by Flow Cytometry and Its Application
摘要
Abstract
Objective To develop an accurate,rapid and sensitive flow cytometry method for the determination of anti-mesenchymal stem cell antibody in cynomolgus monkey serum.Methods After the solutions of mesenchymal stem cell were centrifuged and washed,and the suspension was taken,positive controls or actual samples were added and incubated with mesenchymal stem cell,then were incubated with protein L-PE solution.After the removal of the free protein L-PE,the mean fluorescence intensity of the PE was detected by flow cytometry.Results The method sensitivity is 115.54 ng·mL-1,far higher than the non-clinical research recommended sensitivity of 250-500 ng·mL-1.The precision of intra-assay and inter-assay were less than 20%.Assay cut points,low positive control concentration determination,sensitivity,precision and stability were validated in this study.Conclusion The method is proved to be sensitive,specific,rapid and suitable for the determination of anti-mesenchymal stem cell antibody in monkey serum and immunogenicity study.关键词
间充质干细胞/食蟹猴血清/抗药抗体/免疫原性/流式细胞术Key words
Mesenchymal stem cell/Cynomolgus monkey serum/Anti-drug antibody/Immunogenicity/Flow cytometry分类
医药卫生引用本文复制引用
庄炜平,胡芹,姜宏梁,黄建耿,武栋成..流式细胞术测定食蟹猴血清中抗间充质干细胞抗药抗体及其应用[J].医药导报,2023,42(12):1791-1795,5.基金项目
湖北省科技厅重点研发计划项目(2020BCB045) （2020BCB045）
2020-2021年度湖北省博士后创新实践岗位. （）
