SBIR Phase II: Efficient and Scalable Production of Functionalized Electrospun Nanofiber Felts of Regenerated Cellulose with Superior Capacity and Throughput for Bioseparations

This Small Business Innovation Research (SBIR) Phase II project from Nanofiber Separations, LLC will establish an innovative type of bioseparation media utilizing electrospun nanofiber felts/mats of regenerated cellulose with high specific surface area as the support for protein adsorption ligands. Compared to competitive products (e.g., packed resin beads or microfiber adsorption membranes), these nanofiber membranes/felts will provide greatly enhanced throughput (i.e., shorter processing times), reduce the amount of waste generated, and decrease the volume of media required (i.e., lower costs and smaller operating footprints) for purification of high-value biopharmaceutical products. The SBIR Phase I project was completed successfully by developing a manufacturing process for the functionalized nanofiber felts and proving superior performance compared to commercial products. This SBIR Phase II project will focus on further optimization of the formulations used during production of the nanofiber adsorbents for bioseparations. This will include two scale-up steps needed for the commercial manufacturing effort anticipated during the Phase II timeline (nanofiber felt production, surface functionalization, and module development). Key technical improvements, including greater product stability and a broader array of functional ligands needed in bioseparations, will continue to be made to the nanofiber felts/mats. The broader impact/commercial potential of this project goes well beyond bioseparations. Due to the many advantages of the surface-functionalized electrospun nanofibers made from regenerated cellulose, this innovative adsorption material has tremendous commercial potential. Customers will come from companies within the biopharmaceutical industry, as well as from the established manufacturers of bioseparations adsorption media. Additionally, the underlying fundamentals associated with nanofiber adsorption media will have a wide range of implications, including more efficient separation processes in the water purification industry and the blood products and/or blood purification industries. The advantages achieved through this innovative work will lead to more efficient separation technologies across many sectors and include faster processes, reduced energy consumption, lower materials requirements, and less waste generation. In addition to the broader scientific impacts, Nanofiber Separations, LLC is committed to creating jobs and to training highly technical staff members, providing them with expertise in the interdisciplinary fields of advanced functional materials (including nano-scaled materials) and/or biotechnology.