Over the last several years, the biopharmaceutical industry has had a significant focus on connected and continuous processing to improve both process economics and plant utilization. As opposed to the traditional polishing trains comprised of bind-elute chromatography operations, an all flow-through polishing train easily enables connected and continuous processing while simultaneously improving process economics, flexibility, and productivity. Leveraging commercially available and novel prototype chemistries and devices, we investigated how a properly designed flow-through polishing train can be used to meet the stringent demands expected for mAb polishing purification. A streamlined methodology will be described with two monoclonal antibody molecules to investigate the performance of individual units as well as synergies between technologies. For both individual technologies and connected processes, results will be discussed on their ability to meet purity and yield targets robustly. Finally, we will show how leveraging the integrated combination of unit operations can result in improved performance over the standard batch, segregated processing paradigm including economic benefits of the flow-through polishing toolbox using BioSolve modeling.

Process development for continuous flow-through polishing purification for mAb processing

ACS Fall 2020 Virtual Meeting

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