Rapid Process Development: How a Synthetic Depth Filter Offers a Platform Approach for Efficient Virus Filtration Operations

Virus filtration is a critical unit operation in recombinant protein purification processes. Process development of virus filtration operations typically strives to maximize filter capacity and improve process robustness. Adsorptive prefilters are often used to remove higher order protein aggregates and improve filter capacity. While adsorptive membrane prefilters offer easy scale up and implementation, their narrow operating window may result in extensive process development screening studies. By contrast, synthetic depth filters offer a wide operating window and the potential for a platform approach for protection of virus-retentive filters across a range of operating conditions. Results from our studies demonstrates how a synthetic depth filter can increase filter capacity with multiple monoclonal antibody process intermediates. Optimizing the virus retentive filtration operation with a simple, platform approach enables rapid process development while meeting critical outcomes such as cost efficiency, confident scaling, and risk mitigation for viral clearance studies.