期刊
PREPARATIVE BIOCHEMISTRY & BIOTECHNOLOGY
卷 49, 期 6, 页码 623-638出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/10826068.2019.1615504
关键词
Adsorption models; liquid chromatography; mass transport models; mechanistic modeling
类别
资金
- Department of Biotechnology, Ministry of Science and Technology [BT/COE/34/SP15097/2015]
Liquid chromatography is considered to be the bottleneck for purification of therapeutic proteins. Development and optimization of chromatography process is a cumbersome activity due to the increasing complexities in the types and content of impurities present in the high product titer cell culture harvest obtained from the upstream processing. Further, regulatory expectations are continuously rising with the recent initiatives of quality by design and process analytical technology expecting the manufacturer to have a deeper understanding of the process and the product. Mechanistic modeling is one approach to gain this deeper understanding of a process step. It involves modeling of the underlying physicochemical processes. A well calibrated model with acceptable predictability can be very effective in both process optimization and process characterization activities. In this paper we provide an overview of mechanistic modeling of liquid chromatography. We discuss the various components that such a model entails and also presents the status quo of this area.
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