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单抗工艺相关杂质分析
释义
单抗工艺相关杂质分析
Encyclopedia
医学
单克隆抗体检定
释
process related impurity analysis of monoclonal antibody
单抗工艺相关杂质分析
对单抗生产过程中产生的来自培养细胞(宿主细胞蛋白、宿主细胞DNA等)、培养基和下游工艺(试剂、层析柱相关物质等)的相关杂质,采用适当的经过验证的方法进行评估和分析,供试品测定结果应在该产品规定的范围内。
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protein assembly
protein basic physicochemical properties prediction
protein biogenesis
protein biosynthesis
Protein & Cell
protein chemical biology
protein chemistry
protein chip
protein chromatography column
protein chromatography workstation
protein complementary action
protein complex
protein complex immunoprecipitation
protein content determination
protein C system
protein data bank
protein database
protein database; protein data bank (PDB)
protein deglycosylation
protein degradation
protein demethylation
protein denaturation
protein dephosphorylation
protein desalting
protein detecion of genetically modified ingredients
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