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单抗纯度和杂质分析
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单抗纯度和杂质分析
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医学
单抗纯度和杂质分析
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purity and impurity analysis of monoclonal antibody
单抗纯度和杂质分析
对于单抗的纯度分析,应首先明确与单抗功能和活性密切相关的质量属性,并根据不同质量属性对单抗功能和活性的影响,设定其纯度和杂质,而杂质也进一步分为产品相关杂质和工艺相关杂质。
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