A bridging immunogenicity assay for monoclonal antibody: case study with SHR-1222
文献类型：期刊论文
| 作者 | Zhang, Dan2,3; Yang, Changyong1,4,5,6; Chen, Xiaoyan2 ; Li, Xiuli2; Zhong, Dafang2
|
| 刊名 | BIOANALYSIS
 |
| 出版日期 | 2018-07 |
| 卷号 | 10期号:14页码:1115-1127 |
| 关键词 | ADAs anti-drug antibodies bridging immunogenicity assay monoclonal antibody (mAb) SHR-1222 |
| ISSN号 | 1757-6180 |
| DOI | 10.4155/bio-2017-0289 |
| 文献子类 | Article |
| 英文摘要 | SHR-1222 is a humanized monoclonal antibody targeted to soluble sclerostin. To support the pre-clinical study of SHR-1222 in cynomolgus monkeys, a method for the detection of anti-drug antibodies is required. Results: A bridging immunogenicity method for the detection of anti-SHR-1222 antibodies was developed and validated. In the method, minimal required dilution, normalization factor and confirmatory cut point were 1:20, 4.35 and 10.45%, respectively. The method was successfully applied to evaluate a multiple-dose toxicity study in monkeys. Conclusion: The proposed method allows for the detection of anti-SHR-1222 antibodies in preclinical studies and aids in the interpretation of pharmacokinetic changes in certain animals. The soluble targets interference on anti-drug antibody detection can be blocked or decreased by the therapeutic drug. |
| WOS关键词 | TARGET INTERFERENCE ; DRUG ; IMMUNOASSAYS ; PRODUCTS |
| 资助项目 | Strategic Priority Research Program of the Chinese Academy of Sciences[XDA12050306] |
| WOS研究方向 | Biochemistry & Molecular Biology ; Chemistry |
| 语种 | 英语 |
| WOS记录号 | WOS:000442734200006 |
| 出版者 | FUTURE SCI LTD |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/279671]  |
| 专题 | 上海药物代谢研究中心 中科院受体结构与功能重点实验室 新药研究国家重点实验室 |
| 通讯作者 | Li, Xiuli; Zhong, Dafang |
| 作者单位 | 1.Hengrui Med Co Ltd, Preclin Dept, Lianyungang 222047, Jiangsu, Peoples R China 2.Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, 501 Haike Rd, Shanghai 201203, Peoples R China; 3.Univ Sci & Technol China, Nano Sci & Technol Inst, Suzhou 215123, Peoples R China; 4.Southeast Univ, Res Ctr, Nanjing 211189, Jiangsu, Peoples R China; 5.Southeast Univ, Sch Chem & Chem Engn, Nanjing 211189, Jiangsu, Peoples R China; 6.Southeast Univ, Prov Hitech Key Lab Biomed Res, Nanjing 211189, Jiangsu, Peoples R China; |
| 推荐引用方式 GB/T 7714 | Zhang, Dan,Yang, Changyong,Chen, Xiaoyan,et al. A bridging immunogenicity assay for monoclonal antibody: case study with SHR-1222[J]. BIOANALYSIS,2018,10(14):1115-1127. |
| APA | Zhang, Dan,Yang, Changyong,Chen, Xiaoyan,Li, Xiuli,&Zhong, Dafang.(2018).A bridging immunogenicity assay for monoclonal antibody: case study with SHR-1222.BIOANALYSIS,10(14),1115-1127. |
| MLA | Zhang, Dan,et al."A bridging immunogenicity assay for monoclonal antibody: case study with SHR-1222".BIOANALYSIS 10.14(2018):1115-1127. |
入库方式： OAI收割
来源：上海药物研究所
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