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为单克隆抗体（mAb）制造应用提供可扩展的、大容量切向流过滤（TFF）系统。这项技术的主要受益者是生物制造商和生物加工集成商。然而，为合作的行业伙伴节省的货物成本（cog）可能是深远的。这项技术可以高效（和低成本）生产救命药物和疫苗。降低总成本将有可能使所有人更容易获得和负担得起这些拯救生命的治疗方法，无论其社会经济地位如何。该方案提供的独特、可持续、经济的膜制造方法可以通过生产具有窄孔径分布和高抗污性的膜来改善膜制造行业。除生物加工行业外，许多行业都受益于高性能膜，包括食品和饮料制造商、水处理设施、医疗保健提供商和其他制造企业。拟议的项目是利用比传统工艺更具可持续性和成本效益的合成工艺开发一种病毒过滤膜。由于膜超滤具有可扩展性、可复制性和用户体验等优点，制药商依赖膜超滤。然而，膜防污会阻碍连续生物处理生产效率的充分实现。膜污染导致蛋白质变形和损失，限制了膜在有效分离病毒/蛋白质方面的应用。该膜具有更窄的孔径分布和更强的抗污能力，无需任何后处理。此外，所提出的膜制造技术简化了膜的生产过程，通过消除溶剂的使用，消除了溶剂的回收和回收的需要，降低了制造成本。将新型膜产品应用到现有的生物处理系统中，可以提高制造商采用更有效的连续生产方法的能力，提供诸如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。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.