STTR Phase I: Developing antifouling viral clearance membranes to enable efficient monoclonal antibody (mAb) processing

Award ID: 2212947

The broader impact of this small Business Innovation Research (SBIR) Phase I project is to enable a scalable, high-volume Tangential Flow Filtration (TFF) system for monoclonal antibody (mAb) manufacturing applications. The primary benefactor of this technology is the biomanufacturers and bioprocessing integrators. However, the cost of goods (COGs) savings provided to the collaborating industry partners could be far-reaching. This technology could enable efficient (and lower cost) production of lifesaving drugs and vaccines. Reducing overall cost will potentially make these life-saving therapeutics more accessible and affordable to all people regardless of socioeconomic status. The unique, sustainable, and cost-effective membrane fabrication approach offered in this proposal could improve the membrane manufacturing industry by producing membranes containing narrow pore size distribution and high fouling resistance. Many industries beyond bioprocessing stand to benefit from high-performance membranes, including food and beverage manufacturers, water treatment facilities, healthcare providers, and other manufacturing enterprises. The proposed project is to develop a virus filtration membrane using a synthesis process that is more sustainable and cost-effective than the conventional process. Pharmaceutical manufacturers rely upon membrane ultrafiltration due to its advantages of scalability, replication, and user experience. However, membrane antifouling can hinder a full realization of continuous bioprocessing production efficiencies. Membrane fouling causes protein deformation and loss, limiting membrane applications for efficient virus/protein separation. The proposed membranes have a narrower pore size distribution and stronger fouling resistance without using any post-production processes. Additionally, the proposed membrane fabrication technology simplifies the membrane production process and reduces the manufacturing costs by eliminating the use of solvents, eliminating the need for solvent reclamation and recycling. The adoption of the novel membrane product into existing bioprocessing systems could advance manufacturers ability to adopt a more efficient continuous production method providing potential advantages such as smaller facility footprints, lower investment costs, increased flexibility, and lower processing costs. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

NSF Program Director: Erik Pierstorff