停留时间分布
停留时间(流体动力学)
关键质量属性
单克隆抗体
糖基化
化学
连续生产
结垢
滤波器(信号处理)
过程(计算)
生物系统
工艺工程
色谱法
化学工程
抗体
计算机科学
生物化学
生物
膜
工程类
免疫学
矿物学
操作系统
物理化学
包裹体(矿物)
岩土工程
粒径
计算机视觉
作者
Tim Brantley,Jon Bogue,Kurtis Denny,Sanaa Elouafiq,Seth Madren,Bassam Nakhle,Sarwat F. Khattak
摘要
Residence time distribution modeling of integrated perfusion to capture process can elucidate the impact of product quality excursions and filter fouling on monoclonal antibody production. In this case study, a glycosylation inhibitor and fluorescently labeled antibody are applied to the continuous process to study protein quality modulation, perfusion filter fouling, and unit operation hold times. The unit operations were modeled as continuous-stirred tank reactors and the residence time distribution of a small molecule glycan inhibitor and impact on glycosylation were characterized. A fluorescently labeled antibody was applied as a tracer molecule and confirmed the impact of packed cell volume and filter fouling. This study demonstrates how a biologics continuous process can be modeled and characterized through residence time distribution to ensure a robust, well-understood process.
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