细胞库分析服务

关键性指导原则

• 关于公开征求ICH指导原则《Q5A(R2)：来源于人或动物细胞系生物技术产品的病毒安全性评价》意见的通知
• 《中国药典2020版三部：生物制品生产检定用动物细胞基质制备及质量控制》
• The United States Pharmacopeial，General Chapter 63，Mycoplasma  Tests,General Chapter 71,Sterility test.
• US FDA PTC 1993 Points to Consider Document on the Characterization of Cell Lines Used to Produce Biologicals.
• US FDA PTC 1997 Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. 
• WHO Technical Report Series 978, WHO Expert Committee on Biological Standardization, Annex 3 Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks.
• EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products
• EMA Guideline on Virus Safety Evaluation of Biotechnological Investigational products.
• ICH, Q5D Derivation and characterization of cell substrates used for production of biotechnological/biological products.

细胞库分析服务项目

1. 细胞鉴别试验
2. 无菌及支原体检查（含干扰实验）
3. 内、外源病毒因子检查

具体产品/检项、中美双申报等详细内容，欢迎垂询！