Mathematical modeling and process analytical technology for continuous chromatography of biopharmaceutical products
1Department of Chemical and Biomolecular Engineering, University of Delaware, Newark, DE 19716, USA.
Abstract:
Chromatography is a widely used separation method that is inherently a batch operation. However, the demand for higher productivity and lower cost and labor has prompted industries such as the petrochemical and food industries to transition from batch to continuous chromatography. Growing market competition in the biopharmaceutical industry and the rise of novel biotherapeutics modalities have brought about promising continuous chromatography methods as well as next-generation tools to enable continuous operation in bioprocessing. While these continuous chromatography methods outperform their batch counterpart, their implementation presents challenges due to their greater complexity. This review discusses two key technologies that are essential for the implementation of continuous chromatography: mathematical modeling and novel process analytical technologies. Mechanistic-based models not only aid in process development and optimization but also allow for greater process control and automation.
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