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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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医学
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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locally dense leaf
locally equicontinuous semigroup
locally equivalent structures
locally Euclidean
locally Euclidean group
locally Euclidean space
locally factorial ring
locally faithful representation
locally finite
locally finite algebra
locally finite base
locally finite category
locally finite complex
locally finite covering
locally finite family
locally finite family of sets
locally finite graph
locally finite group
locally finite module
locally finite quiver
locally finite radical
locally finite semigroup
locally finite space
locally finite sum
locally flat
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