Consideration of antibody drug conjugates development and regulation
10.16438/j.0513-4870.2020-0325
- VernacularTitle:抗体偶联药物研发及药学审评要点
- Author:
Zhong-bing ZHANG
1
;
Yang WANG
1
;
Yu BAI
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
- Publication Type:Research Article
- Keywords:
monoclonal antibody;
antibody drug conjugate;
cytotoxic payload;
linker;
marketing authorization application
- From:
Acta Pharmaceutica Sinica
2020;55(8):1971-1977
- CountryChina
- Language:Chinese
-
Abstract:
Antibody drug conjugates (ADCs), as they combine the targetability of monoclonal antibody and cytotoxicity of small molecules, are a growing class of therapeutics for cancer. The key factor of ADCs development is the accurate selection of parameters including tumor target, monoclonal antibody, cytotoxic payload, and linkage strategy of antibody to payload. Here, we summarize the main elements in the structural design and the development of ADCs, as well as the regulatory consideration of product manufacturing and control, which would be helpful for the research and development of ADCs.
