Q5
Quality of Biotechnological Products
生物技术产品的质量
编号阶段内容
Q5A(R1)Step 5Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
来源于人或动物细胞系的生物技术产品的病毒安全性评价
Q5BStep 5Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
生物技术产品的质量:rDNA衍生蛋白质产品生产细胞的表达构建体分析
Q5CStep 5Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
生物技术产品的质量:生物制品/生物技术产品的稳定性试验
Q5DStep 5Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
用于生物技术产品及生物制品生产的细胞基质的来源和鉴定
Q5EStep 5Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
生物技术产品/生物制品在工艺变更时的可比性
 
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