This Small Business Innovation Research (SBIR) Phase I project from Nanofiber Separations, LLC will establish an innovative type of bioseparation media utilizing electrospun nanofiber felts 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 study of these separation materials and processes will increase the scientific knowledge of the absorption characteristics of biomaterials at the nanoscale. This SBIR Phase I project will focus on optimization of a scalable production process for the felts, including pilot scale production of the nanofiber mats, along with functionalization of the fibers for superior capacity, elevated throughput, and highly selective bioseparations.
The broader impact/commercial potential of this project centers on providing advanced separation media for the biopharmaceutical, water purification, and blood products industries. Because of the advantages of the proposed product, the innovative adsorption felts produced from electrospun nanofibers of regenerated cellulose have a tremendous amount of commercial potential. Customers will come from companies within the biopharmaceutical industry, as well as the established manufacturers of bioseparations adsorption media. In addition, the underlying fundamentals associated with nanofiber adsorption media will have a wide range of implications, including 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, such as 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 and training highly technical staff members with expertise in the interdisciplinary fields of nanoscience/nanoengineering and biotechnology.
Introduction: Nanofiber Separations, LLC has produced a newly developed electrospinning process that generates a robust felt/mat of cellulose nanofibers that can be functionalized for bioseparation applications. The advanced nanofiber mats maintain structural stability throughout the functionalization process, which has been verified with SEM and FTIR analysis. These nano-felts possess an ultra-high surface area to bed volume ratio, elevated permeability, and contain an enormous amount of selective ligands for bioseparations to create a filter that can meet the needs of the biopharmaceutical industry. Intellectual Impact: The study of these separation materials and processes increases the scientific knowledge of the absorption characteristics of biomaterials at the nanoscale. The SBIR Phase I and IB projects established an innovative type of bioseparation media utilizing electrospun nanofiber felts with high specific surface area as the support for protein adsorption ligands. Compared to competitive products like packed resin beads or microfiber adsorption membranes, these nanofiber membranes/felts provide a greatly enhanced throughput (shorter processing times), reduce the amount of waste generated, and decrease the volume of media required (lower costs and smaller operating footprints) for the purification of high-value biopharmaceutical products. The work completed by Nanofiber Separations, LLC has resulted in improved electrospinning formulations and operating conditions that allow for larger scale manufacturing of the advanced materials. In addition, process development achievements have provided methods that reduce manufacturing times by over 80% with a reproducible and saleable process for producing large amounts of the proprietary separation product. Broader Impact: The broader impact of this project centered on providing advanced separation media for the biopharmaceutical, water purification, and blood products industries. Because of the advantages of the proposed product, the innovative adsorption felts produced from electrospun nanofibers have a tremendous amount of commercial potential. Interest will come from companies within the biopharmaceutical industry, as well as the established manufacturers of bioseparations adsorption media. The advantages achieved through this innovative work will lead to more efficient separation technologies across many sectors, such as faster processes, reduced energy consumption, lower materials requirements, and less waste generation. The highly advanced and proprietary formulation provides the opportunity to greatly enhance process efficiencies and economics in the biopharmaceutical, water treatment, desalination, blood products, and air purification industries. The nanofiber mats provide superior adsorptive binding capacity (allowing for a much lower amount of separation medium and smaller units), elevated permeability (allowing for much faster throughput, reduced labor requirements, and more efficient utilization of finite manufacturing capacity), improved selectivity (allowing for more streamlined and fewer operations), reduced waste generation (lowering operational costs), and simplification of processing operations (reducing the risks associated with operator error, reducing validation requirements and improving product consistency). Process and economic modeling was completed and provided the following results: Over 30% reduction in overall operating costs per kg of product, which can account for over $110 million annual savings for a single product; Over 10-times faster throughput allowing for shorter processing times, reduced labor, more efficient use of limited manufacturing space (responsible for ~44% of the lower operating costs); Over 10-times lower operating pressures, which provides less frequent failure of media, no compaction of media, lower pumping and piping costs (~13% of the lower operating costs); Over 10-times higher capacity – lower materials requirements (~33% of the lower operating costs); Over 5-times less water consumption, allowing for reduced loads on purified water systems (~8% of the lower operating costs); Over 5-times less waste generation, providing more environmentally friendly production processes and lower waste disposal costs (~3% of lower operating costs); The Nanofiber Separations technology will revolutionize the way human therapeutics is purified. Beyond that, functionalized nanofiber adsorption units will quickly replace packed bed separation operations within all new biopharmaceutical production processes within eight years, primarily because of major cost reductions and processing simplifications. The rapidly growing biotechnology and biopharmaceutical industries are looking for more cost effective ways to meet strict purity regulations placed on this industry, and the key features of the novel nanofiber felts follow directly from the needs of the biopharmaceutical arena: easy operation, low volume of media required, high throughput, low waste generation, and a targeted overall reduction in processing costs by over 30%. Currently, three patent applications are being developed by Nanofiber Separations, LLC pertaining to the technology and scaled-up production processes.
