Bioanalysis in the development of antibody-drug conjugates
文献类型：期刊论文
| 作者 | Li Xiuli; Chen Xiaoyan ; Zhong Dafang
|
| 刊名 | Acta Pharmaceutica Sinica
 |
| 出版日期 | 2016 |
| 卷号 | 51期号:4页码:517-528 |
| 关键词 | antibody-drug conjugate drug-to-antibody ratio immunogenicity enzyme-linked immunosorbent assay LC-MS |
| ISSN号 | 0513-4870 |
| 其他题名 | 抗体偶联药物研发中的生物分析 |
| 文献子类 | Review |
| 英文摘要 | Antibody-drug conjugates (ADCs) are complex molecules with cytotoxic small molecular drugs covalently bound to monoclonal antibodies via a linker and can improve the targeted drug delivery with minimizing the systemic toxicity. ADCs are heterogeneous mixtures with different drug-to-antibody ratios (DARs) and the DAR distribution is dynamically changing in vivo, therefore the bioanalysis of the ADCs is challenging. Enzyme-linked immunosorbent assay (ELISA) and LC-MS have been widely used in the ADCs bioanalytical assays. Just like other biotherapeutics, ADCs may elicit the host immune response and produce the anti-therapeutic antibody (ATA), which could affect its efficacy, pharmacokinetics, and safety. It is thereby important to investigate its immunogenicity in the ADC development. In this review, we summarized the ELISA- and LC-MS-based bioanalysis strategies for the development of ADCs, including DAR distribution, the determination of total antibody, conjugated antibody, conjugated drug, free drug, and ATA, with the expectation of providing insights and reference for the ADC development in China. |
| WOS研究方向 | Pharmacology & Pharmacy (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:5681931 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/269254]  |
| 专题 | 上海药物代谢研究中心 |
| 通讯作者 | Zhong Dafang |
| 作者单位 | Shanghai Center for Drug Metabolism and Pharmacokinetics Research, Shanghai Institute of Materia Medica,Chinese Academy of Sciences, Shanghai 201203, China. |
| 推荐引用方式 GB/T 7714 | Li Xiuli,Chen Xiaoyan,Zhong Dafang. Bioanalysis in the development of antibody-drug conjugates[J]. Acta Pharmaceutica Sinica,2016,51(4):517-528. |
| APA | Li Xiuli,Chen Xiaoyan,&Zhong Dafang.(2016).Bioanalysis in the development of antibody-drug conjugates.Acta Pharmaceutica Sinica,51(4),517-528. |
| MLA | Li Xiuli,et al."Bioanalysis in the development of antibody-drug conjugates".Acta Pharmaceutica Sinica 51.4(2016):517-528. |
入库方式： OAI收割
来源：上海药物研究所
浏览0
下载0
收藏0
其他版本
除非特别说明，本系统中所有内容都受版权保护，并保留所有权利。