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Development of a bridging ELISA for detection of antibodies against ZV0203 in cynomolgus monkey serum

文献类型：期刊论文

作者Liu, Tingting1,2,3; Tong, Yongliang3,4; Gao, Jinli3; Fang, Wenjing3; Wu, Junliang3; Peng, Xionghua6; Fan, Xiaotian3; Chen, Xiaoqiang3; Sun, Jianhua3; Cao, Sheldon7
刊名JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS
出版日期2023
卷号119页码:10
ISSN号1056-8719
关键词Antibody-drug conjugate Immunogenicity Anti-drug antibody Bridging ELISA
DOI10.1016/j.vascn.2022.107210
通讯作者Gong, Likun(lkgong@simm.ac.cn) ; Qin, Qiuping(qpqin@cdser.simm.ac.cn) ; Ju, Dianwen(dianwenju@fudan.edu.cn)
英文摘要Immunogenicity has been a major concern in the safety evaluation of therapeutic proteins. The assessment of the unwanted immunogenicity of the therapeutic proteins performed in animals prior to clinical trials has been a regulatory requirement. In preclinical studies of therapeutic proteins, cynomolgus monkeys are usually the most relevant animal species. ZV0203, a recombinant humanized anti-human epidermal growth factor receptor 2 monoclonal antibody covalently bound to a cytotoxic drug (Duo-5), possesses a novel format of antibody drug conjugates. In this study, we reported the development, validation, and application of a bridging enzyme-linked immunosorbent assay for the detection of antibodies against ZV0203 in cynomolgus monkey serum. Drug interference at low positive control (18.0 ng/mL) and high positive control (130 ng/mL) of anti-ZV0203 antibodies was not observed when ZV0203 concentration is below 1.74 mu g/mL and 1.49 mu g/mL, respectively. In addition, no interference was found from mouse IgG1, but interference was observed with human IgG1. No effect of hemolysis was found on the analysis results of the testing samples present in 100% pooled rabbit serum containing 2% (V/V) erythrocyte hemolysates. Besides, spiked anti-ZV0203 antibody in rabbit serum was stable after 5 freeze/thaw cycles. The results showed that the method is suitable for the detection of anti-ZV0203 antibodies in cynomolgus monkey serum. The assay was also successfully applied in the repeated dose study of ZV0203.
WOS关键词IMMUNOGENICITY ASSESSMENT ; THERAPEUTICS ; INTERPLAY
资助项目National New Drug Creation Program of China[2019ZX09732002-013] ; Chinese Academy of Sciences[XDA12050305]
WOS研究方向Pharmacology & Pharmacy ; Toxicology
语种英语
出版者ELSEVIER SCIENCE INC
WOS记录号WOS:000917338700001
源URL[http://119.78.100.183/handle/2S10ELR8/303540]  
专题中国科学院上海药物研究所
通讯作者Gong, Likun; Qin, Qiuping; Ju, Dianwen
作者单位1.Fudan Univ, Dept Biol Med, Sch Pharm, Shanghai 201203, Peoples R China
2.Fudan Univ, Shanghai Engn Res Ctr Immunotherapeut, Sch Pharm, Shanghai 201203, Peoples R China
3.Chinese Acad Sci, Shanghai Inst Mat Med, Ctr Drug Safety Evaluat & Res, Shanghai 201203, Peoples R China
4.Univ Chinese Acad Sci, Sch Pharm, Beijing 100049, Peoples R China
5.Chinese Acad Sci, Zhongshan Inst Drug Discovery, Shanghai Inst Mat Med, Zhongshan 528400, Guangdong, Peoples R China
6.Nanchang Univ, Sch Pharm, Nanchang 330031, Jiangxi, Peoples R China
7.Eubulus Biotherapeut Inc, Jiaxing 314000, Zhejiang, Peoples R China
8.Hangzhou Biosun Pharmaceut Co Ltd, Hangzhou 310000, Zhejiang, Peoples R China
9.Chinese Acad Sci, Shanghai Inst Mat Med, Dept Ctr Drug Safety Evaluat & Res, Shanghai 201203, Peoples R China
推荐引用方式
GB/T 7714		 Liu, Tingting,Tong, Yongliang,Gao, Jinli,et al. Development of a bridging ELISA for detection of antibodies against ZV0203 in cynomolgus monkey serum[J]. JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS,2023,119:10.
APA Liu, Tingting.,Tong, Yongliang.,Gao, Jinli.,Fang, Wenjing.,Wu, Junliang.,...&Ju, Dianwen.(2023).Development of a bridging ELISA for detection of antibodies against ZV0203 in cynomolgus monkey serum.JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS,119,10.
MLA Liu, Tingting,et al."Development of a bridging ELISA for detection of antibodies against ZV0203 in cynomolgus monkey serum".JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS 119(2023):10.

入库方式： OAI收割

来源：上海药物研究所

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