| 摘要: |
| 对WHO 2013年公布的《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》及我国2015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了介绍、梳理和比较，并对我国兽用生物制品生产用细胞的致瘤性检验要求提供了进一步完善的建议。 |
| 关键词: 传代细胞系、致瘤性 |
| DOI： |
| 投稿时间：2020-08-24修订日期：2020-11-18 |
| 基金项目:中国兽医药品监察所所级课题（201808） |
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| Discussion and suggestion for the test method of tumorigenicity of cells |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| In oder to introduces, sorts out and compares the relevant requirements of the test method of tumorigenicity of cells in Veterinary Pharmacopoeia of the People’s Republic of China(2015) and WHO Recommendations for the Evaluation of Animal Cell Culture as Substrates for the Manufacture of Biological Medicinal Products and for the Characterization(2013). Some suggestions were also provided for further improvement of tumorigenicity requirements for evaluation of cell in China. |
| Key words: Cell line tumorigenicity |
