Technology and Process Development (TPD), WuXi Biologics, Shanghai, China.
Methods Mol Biol. 2021;2178:345-354. doi: 10.1007/978-1-0716-0775-6_23.
In monoclonal antibody (mAb) production, aggregates represent a major class of product-related impurities that needs to be removed by the downstream process. Protein A chromatography is generally less effective at removing antibody aggregates under typical conditions, and in most cases aggregate removal relies on a subsequent polishing chromatography. Here we describe a procedure for effective removal of antibody aggregates using the mixed-mode chromatography resin Capto MMC ImpRes. Clearance of aggregates was confirmed by analytical size-exclusion chromatography (SEC) and native gel electrophoresis.
在单克隆抗体（mAb）生产中，聚集体是主要的一类与产品相关的杂质，需要通过下游工艺去除。在典型条件下，蛋白 A 层析法通常对去除抗体聚集体的效果较差，在大多数情况下，聚集体的去除依赖于后续的抛光层析。在这里，我们描述了一种使用混合模式层析树脂 Capto MMC ImpRes 有效去除抗体聚集体的方法。通过分析尺寸排阻层析（SEC）和天然凝胶电泳确认了聚集体的清除效果。
