Design space: Modelling chromatographic bioseparation in the face of process variability

Advanced process modelling is being used to increase the robustness of chromatographic bioseparations in the face of process variability. This presentation describes how the development and validation of a mechanistic model of a chromatographic separation where resin lot variability can cause significant performance issues. The model was successfully applied to enable process operation further away from high risk regions, to increase the size of operating regions and improve flexibility to variations in process inputs