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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛影响是实现了一种可扩展的大容量切向流过滤(TFF)系统，用于单抗(MAb)制造应用。这项技术的主要受益者是生物制造制造商和生物处理集成商。然而，提供给合作行业合作伙伴的货物成本(COG)节省可能影响深远。这项技术可以高效(且成本更低)地生产救命药物和疫苗。降低总成本可能会使所有人更容易获得和负担得起这些拯救生命的疗法，无论他们的社会经济地位如何。这种独特的、可持续的、成本效益高的膜制造方法可以通过生产具有窄孔径分布和高耐污性的膜来改善膜制造行业。生物加工以外的许多行业都将受益于高性能膜，包括食品和饮料制造商、水处理设施、医疗保健提供者和其他制造企业。拟议的项目是利用一种比传统工艺更可持续和更具成本效益的合成工艺来开发一种病毒滤膜。由于膜超滤在可伸缩性、重复性和用户体验方面的优势，制药制造商依赖于膜超滤。然而，膜的防污染会阻碍连续生物处理生产效率的充分实现。膜污染会导致蛋白质的变形和丢失，从而限制了有效分离病毒/蛋白质的膜应用。所提出的膜具有更窄的孔径分布和更强的抗污染能力，而不需要任何后处理工艺。此外，拟议的膜制造技术通过消除溶剂的使用，消除了溶剂回收和再循环的需要，简化了膜的生产工艺，降低了制造成本。在现有的生物处理系统中采用新型膜产品可以提高制造商采用更高效的连续生产方法的能力，从而提供更小的设施占地面积、更低的投资成本、更高的灵活性和更低的处理成本等潜在优势。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.