Determination of Anti-Mesenchymal Stem Cell Antibody in Cynomolgus Monkey Serum by Flow Cytometry and Its Application
10.3870/j.issn.1004-0781.2023.12.008
- VernacularTitle: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
- Author:
Weiping ZHUANG
1
,
2
,
3
;
Qin HU
;
Hongliang JIANG
;
Jiangeng HUANG
;
Dongcheng WU
Author Information
1. 武汉生物技术研究院,武汉 430073
2. 武汉宏韧生物医药股份有限公司,武汉 430073
3. 华中科技大学同济医学院药学院,武汉 430030
- Keywords:
Mesenchymal stem cell;
Cynomolgus monkey serum;
Anti-drug antibody;
Immunogenicity;
Flow cytometry
- From:
Herald of Medicine
2023;42(12):1791-1795
- CountryChina
- Language:Chinese
-
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.
