单克隆抗体
二硫键
毛细管电泳
还原(数学)
化学
单体
色谱法
抗体
计算生物学
生物化学
生物
免疫学
有机化学
数学
几何学
聚合物
作者
Yanhong Yang,Niutish Bastani,Sara K. Lagler,Doug Harris,Attila Nagy,Peifeng Chen,Aakash Patel,Yile Li,Daniel B. Gowetski,Q. Paula Lei
摘要
Monoclonal antibody (mAb) interchain disulfide bond reduction has been observed in a recent large-scale clinical manufacturing operation. A massive reduction/precipitation at post-clarification steps has occurred. This note presents the development of a novel analytical approach to identify the "potential reduction"-a unique approach to predict the propensity of a monomeric-profiled mAb to be reduced in the post-harvest stage, such as harvest clarification and/or purification steps. The core of this new approach includes comparing the non-reducing capillary electrophoresis profiles of pre- and post-vacuum treated mAb in harvest cell culture fluid (HCCF). Using this approach, the potential reductions of two in-house mAbs in the unclarified and clarified cell culture harvest were assessed.
科研通智能强力驱动
Strongly Powered by AbleSci AI