中国当代医药2023，Vol.30Issue(34)：18-22,5.
基于中美药典要求的抗肝细胞生长因子受体抗体生物学活性方法学验证平台的建立
Establishment of a methodological validation platform for biological activ-ity of anti-hepatocyte growth factor receptor based on the requirements of Chinese and American pharmacopoeia
贠莎莎 1刘荣 2姚雪静1
作者信息
- 1. 荣昌生物制药(烟台)股份有限公司,山东烟台 264000
- 2. 山东省食品药品审评查验中心,山东济南 250000
- 折叠
摘要
Abstract
Objective To establish a methodological validation verification platform for the biological activity of anti-hepatocyte growth factor receptor(C-Met)antibody in accordance with the requirements of Chinese and American pharmacopoeia.Methods An antibody-dependent cell-mediated cytotoxicity(ADCC)assay model based on reporter gene was used to validate the biological activity of anti-C-Met antibodies.The content and scope of the assay were determined by risk assessment.The biological activity method was verified from seven aspects:specificity,repeatability,intermediate precision,relative accuracy,linearity,range and durability.Results The method had good specificity,repeatability,intermediate precision,relative accuracy and linearity.The measuring range of the method is 50％-200％.Durability test passed.Conclusion The validation platform of biological activity methods in accordance with the requirements of Chinese and American pharmacopoeia was established in this research,and the validation of biological activity methods required for international application of biological products enterprises was provided as an example reference.关键词
生物学活性/方法验证/报告基因/中间精密度Key words
Biological activity/Methodological validation/Reporter gene/Intermediate precision分类
医药卫生引用本文复制引用
贠莎莎,刘荣,姚雪静..基于中美药典要求的抗肝细胞生长因子受体抗体生物学活性方法学验证平台的建立[J].中国当代医药,2023,30(34):18-22,5.
