摘要
2013年WHO生物制品标准化专家委员会发布了最新版的动物细胞基质生产生物医药产品和细胞库特性的评价建议(Recommendations for the Evaluation of Animal Cell Culture as Substrates for the Manufacture of Biological Medicinal Products and for the Characterization,简称技术指南),该技术指南对我国药品管理机构制定关于生产用细胞库的检定与特性描述的相关技术要求具有很好的参考意义。对发布WHO技术指南及我国现行版《中华人民共和国兽药典》三部中涉及的细胞致瘤性检验相关要求进行介绍、梳理和比较,并从检验方法要求和内容的完善、体外替代方法等方面进行探讨。
In 2013,the WHO expert committee on biological standardization issued the latest edition of recommendations for the evaluation of animal cell culture as substrates for the manufacture of biological medicinal products and for the characterization.This technical guide has a good reference significance for the drug administration institutions in China to formulate the relevant technical requirements for the verification and characterization of production cell banks.This paper introduces,sorts out and compares the requirements related to the tumorigenicity test of cells involved in the release of who technical guidelines and Veterinary Pharmacopoeia of the People′s Republic of China(2015).
作者
王磊
杨承槐
刘莹
WANG Lei;YANG Cheng-Huai;LIU Ying(China Institute of Veterinary Drug Control,Beijing 100081,China)
出处
《中国兽药杂志》
2020年第12期26-30,共5页
Chinese Journal of Veterinary Drug
基金
中国兽医药品监察所所级课题(201808)。
关键词
传代细胞系
致瘤性
检验方法
生物制品
cell line
tumorigenicity
test method
biological products
