Validation of analytical method for molecular size variants in monoclonal antibodies based on size-exclusion high-performance liquid chromatography
10.13200/j.cnki.cjb.004594
- VernacularTitle:基于分子排阻高效液相色谱的单克隆抗体分子大小变异体分析方法验证
- Author:
Yalan YANG
- Publication Type:Journal Article
- Keywords:
ICH Q2(R2);
Monoclonal antibodies;
Molecular size variants;
Size-exclusion high-performance liquid chromatography(SEC-HPLC);
Method validation
- From:
Chinese Journal of Biologicals
2025;38(11):1358-1365
- CountryChina
- Language:Chinese
-
Abstract:
Objective To verify the size-exclusion high-performance liquid chromatography(SEC-HPLC) method for molecular size variant analysis in monoclonal antibodies which is to be included in the Chinese Pharmacopoeia(VolumeⅢ, 2025 edition), in accordance with t
