摘要：目的 开发并评估一种单克隆抗体药物的等电点及电荷异质体检测方法。 方法 通过成像毛细管等电聚焦电泳(iCIEF)技术，根据不同类型蛋白等电点不同的特性，实现检测单抗药物等电点并分离其电荷异质体的目的。 预期结果 通过iCIEF手段，实现了单克隆抗体的等电点的检测、电荷异质体的分离与检测。
关键词：单克隆抗体；等电点；电荷异质体；全柱成像毛细管等电聚焦
Development and evaluation of a protein drug
charge heterogeneity detection method
Opening report
Liu Chuhan
Abstract: Purpose Develop and evaluate a method for the detection of isoelectric point and charge heterogeneity of monoclonal antibody. Method According to the difference of isoelectric points of different proteins, by the method Imaged Capillary Isoelectric Focusing (iCIEF) , the purpose of detecting the isoelectric points of monoclonal antibody drugs and separating their charge heterogeneity will be realized. Expected results The detection of isoelectric point, separation and detection of charge heterogeneity of monoclonal antibody will be realized by iCIEF.
Keywords: Monoclonal antibody; isoelectric point; charge heterogeneity; Imaged Capillary Isoelectric Focusing
一、目的
本课题旨在通过iCIEF的方法，开发并评估一种检测单克隆抗体（蛋白药物）的等电点，并同时检测出单克隆抗体的电荷异质体的方法。
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