Journal
JOURNAL OF CHROMATOGRAPHY A
Volume 1218, Issue 31, Pages 5195-5204Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.chroma.2011.05.103
Keywords
Lumped kinetic model; Monoclonal antibody; Continuous chromatography; MCSGP
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The cation-exchange capture step of a monoclonal antibody (mAb) purification process using single column batch and multicolumn continuous chromatography (MCSGP) was modeled with a lumped kinetic model. Model parameters were experimentally determined under analytical and preparative conditions: porosities, retention factors and mass transfer parameters of purified mAb were obtained through a systematic procedure based on retention time measurements. The saturation capacity was determined through peak fitting assuming a Langmuir-type adsorption isotherm. The model was validated using linear batch gradient elutions. In addition, the model was used to simulate the start-up, cyclic steady state and shut down behavior of the continuous capture process (MCSGP) and to predict performance parameters. The obtained results were validated by comparison with suitable experiments using an industrial cell culture supernatant. Although the model was not capable of delivering quantitative information of the product purity, it proved high accuracy in the prediction of product concentrations and yield with an error of less than 6%, making it a very useful tool in process development. (C) 2011 Elsevier B.V. All rights reserved.
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