Aggregation is one of the most challenging aspects in the bioprocessing of therapeutic proteins. Multimodal chromatography utilizes both ion-exchange and hydrophobic modalities, offering a multi-dimensional approach to resolving and removing difficult contaminant species, including aggregates. This research aims to establish a rigorous approach for the development of multimodal separations of monoclonal antibody monomer and aggregates. This approach combines linear gradient screening with column modeling to rapidly evaluate a wide range of potential MM chromatographic conditions for these monomer-aggregate separations. Process development is then carried out to develop efficient bind-elute or flow-through operations. Finally, the utility of this approach is demonstrated for several industrial mAb-aggregate feed stocks.

Investigation of protein monomer-aggregate separations using multimodal chromatography

253rd National Meeting (2017)

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