双特异性抗体
等电聚焦
色谱法
检出限
化学
毛细管电泳
单克隆抗体
荧光
毛细管作用
分析化学(期刊)
抗体
材料科学
生物化学
光学
生物
物理
复合材料
酶
免疫学
作者
Gang Wu,Jialiang Du,Gangling Xu,Meng Li,Chuanfei Yu
出处
期刊:Electrophoresis
[Wiley]
日期:2024-07-08
卷期号:45 (19-20): 1665-1672
被引量:2
标识
DOI:10.1002/elps.202400066
摘要
Abstract An imaged capillary isoelectric focusing (icIEF)‐based method was developed and validated as a multi‐attribute method for a bispecific antibody (BsAb). First, as the traditional application of the icIEF method, it serves as an identity assay and purity assay for the BsAb. Second, the method can also be used as an impurity assay for the homodimer monoclonal antibodies generated during BsAb assembly. The homodimer impurity analysis for BsAb is usually done by hydrophobic interaction chromatography methods in the industry. The icIEF method has good sensitivity (down to 4 µg/mL in a limit of quantitation) when UV fluorescence detection is used, which detects the native fluorescence of proteins. This is the first report that an icIEF method has been applied as impurity assay.
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