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

STTR 第一阶段：开发防污病毒清除膜以实现高效的单克隆抗体 (mAb) 处理

• 批准号: 2212947
• 负责人: Yun Li
• 金额: $ 25.6万
• 依托单位: FILTRAVATE, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2212947&HistoricalAwards=false
• 关键词: STTR; Phase; Developing; antifouling; viral

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.

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。该技术的主要受益者是生物制造商和生物制药公司。然而，该技术可以为合作的行业合作伙伴节省大量的商品成本（COG），从而实现高效（且成本更低）的生产。降低总体成本将有可能使这些挽救生命的疗法对所有人来说都更容易获得和负担得起，无论其社会经济地位如何，该提案中提供的独特、可持续且具有成本效益的膜制造方法可以改善膜制造行业。通过生产孔径分布窄且耐污染性高的膜，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、医疗保健提供商和其他制造企业。病毒过滤膜使用比传统工艺更具可持续性和成本效益的合成工艺，由于膜超滤具有可扩展性、可复制性和用户体验的优势，制药制造商依赖膜超滤，但膜防污可能会阻碍连续生物工艺生产效率的全面实现。膜污染会导致蛋白质变形和损失，限制了有效病毒/蛋白质分离的膜应用，并且在不使用任何后生产过程的情况下，所提出的膜具有更窄的孔径分布和更强的抗污染性。制造技术通过消除溶剂的使用、消除溶剂回收和再循环的需要，简化了膜生产过程并降低了制造成本。在现有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技术的能力。生产方法提供了潜在的优势，例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加工成本。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。