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单抗工艺相关杂质分析
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单抗工艺相关杂质分析
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单克隆抗体检定
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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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