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charge heterogeneity analysis of monoclonal antibody
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charge heterogeneity analysis of monoclonal antibody
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医学
单抗纯度和杂质分析
释
charge heterogeneity analysis of monoclonal antibody
单抗电荷异质性分析
采用等电聚焦电泳(cIEF)、离子交换色谱(IEC-HPLC)、毛细管等电聚焦电泳(iCIEF)、疏水高效液相色谱(HIC-HPLC)、反相高效液相色谱(RP-HPLC)等方法检测供试品电荷变异体,对不同电荷变异体组分进行鉴别,并规定相应的可接受标准。供试品测定结果应在规定的范围内。
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