In recent years, the biopharmaceutical industry recognized the added value of mechanistic modeling techniques as they provide an extended level of process understanding. Mechanistic models, once calibrated, enable to run numerous virtual experiments in an inexpensive and safe way, thereby reducing time and material consumption. However, chromatographic mechanistic models rely on adsorption equilibrium isotherms of the product and other impurities towards the resin. The experimental determination of model parameters can be a tedious task and could partially be automatized using High Throughput Experimentation techniques.<br/>It becomes even more complicated for complex mixtures containing numerous unknown components. The same is applicable for vaccines upstream feeds containing thousands of host cell proteins (HCPs) and other cell related impurities, especially at the capture step which is performed in the presence of large amounts of impurities and aims to achieve an initial quite high product purity by removing most of these impurities. Determination and modeling each components adsorption isotherm would require an unreasonable effort in both time and costs, hence it is unnecessary to model each component of the mixture individually. This presentation will show a chromatographic modeling approach to simulate complex vaccines mixtures by making use of pseudo-component adsorption isotherms for HCPs.

Model-based chromatography process development for complex vaccine mixtures

ACS Fall 2021

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