Zhang Xudong, Chen Tao, Li Yifeng
Technology and Process Development (TPD), WuXi Biologics (A WuXi AppTec Affiliate), 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, 200131, China.
Technology and Process Development (TPD), WuXi Biologics (A WuXi AppTec Affiliate), 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, 200131, China.
Protein Expr Purif. 2019 Jan;153:59-69. doi: 10.1016/j.pep.2018.08.011. Epub 2018 Aug 23.
Aggregation is a major concern for therapeutic monoclonal antibody (mAb), as aggregates reduce drug efficacy and safety. In addition to aggregation control, aggregate removal by downstream processing is crucial. Hydrophobic and mixed-mode resins are widely used for aggregate removal in different cases, but they are seldom compared side by side. In this study, the aggregate removing capability of eight resins belonging to different chromatographic types was demonstrated by a case study. This work, by providing multiple options for aggregate removal, allows more flexibility to be gained in downstream processing.
聚集是治疗性单克隆抗体（mAb）的一个主要问题，因为聚集体会降低药物疗效和安全性。除了控制聚集外，通过下游加工去除聚集体也至关重要。疏水和混合模式树脂在不同情况下广泛用于去除聚集体，但很少进行并排比较。在本研究中，通过一个案例研究展示了属于不同色谱类型的八种树脂的聚集体去除能力。这项工作通过提供多种聚集体去除选项，使下游加工能够获得更大的灵活性。
