色谱法
过程(计算)
软件
批处理
化学
单克隆抗体
计算机科学
抗体
生物
操作系统
程序设计语言
免疫学
作者
Valérie Girard,Nicolas-Julian Hilbold,Candy K.S. Ng,Laurence Pegon,Wael Chahim,Fabien Rousset,Vincent Monchois
标识
DOI:10.1016/j.jbiotec.2015.04.026
摘要
The development and optimization of a purification process of monoclonal antibodies based on two continuous chromatography steps for capture and intermediate purification are presented. The two chromatography steps were individually optimized using either batch chromatography or sequential multicolumn chromatography (SMCC). Proprietary simulation software was used to optimize SMCC and to evaluate the potential gains compared with batch chromatography. The SMCC recipes provided by the simulation software were evaluated experimentally. A good correlation was found between the simulated results and experimental observations. Significant gains were observed on the productivity, buffer consumption and the volume of resin required for SMCC over batch chromatography. Based on these results, a chained process from the capture to polishing steps was implemented. This chained process demonstrated significantly better performance compared with the batch equivalent while satisfying the specifications. The expected positive impact provided by implementing continuous chromatography is also discussed.
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