Nanostructured Ultrafiltration Membranes for Biological Applications

描述（申请人提供）：超滤膜广泛应用于生物和健康相关的研究机构以及生物制药行业，用于快速的基于尺寸的纯化和分离大分子，包括蛋白质、核酸和多糖。重要的医学应用包括血液透析（治疗终末期肾衰竭）和心内直视手术（血液氧合）。尽管市面上有各种规格的膜，但对膜的选择性仍有很大的改进需求。实现这一目标的主要途径是缩小孔径分布，这对现有类型的超滤膜来说是一个挑战。这个多阶段的小企业创新研究项目旨在开发和商业化新型超滤膜，这种膜具有前所未有的锋利和可控的分子量切断和减少污染。需要这样的膜来充分实现超滤在生物和医学大分子处理中的潜在优势。目标产品-新型膜-将适合作为商业膜支架中最先进的膜的直接替代品。拟议的发展将大大改善生物化学和医学研究以及医疗保健应用中天然产物的快速纯化和分离，因此与国家普通医学科学研究所的使命直接相关。第一阶段的主要目标是通过制造和测试超滤膜来证明所提出方法的可行性，并确认其性能优于商业类似物。为了确保二期产品开发和三期商业化的成功，我们与一家低成本无创血糖传感器的开发商建立了早期合作伙伴关系。公共卫生相关性：该项目解决生物医学研究和医疗保健中的一个重大问题：基于尺寸的大分子，包括蛋白质、核酸和多糖的快速纯化和分离。提出了新型高级超滤膜的发展方向，该超滤膜具有前所未有的锐利、可控的分子量切断和减少污染。提出的技术将使一个新的高性能膜家族用于生化分析、实验室研究，并有可能用于治疗终末期肾衰竭的血液透析和用于血液氧合的心脏直视手术。

DESCRIPTION (provided by applicant): Ultrafiltration membranes are being used widely by bio- and health-related research institutions as well as by biopharmaceutical industry for rapid size-based purification and separation of macromolecules, including proteins, nucleic acids and polysaccharides. Important medical applications include hemodialysis (treatment of end-stage renal failure) and open-heart surgery (blood oxygenation). In spite of the fact that a wide range of membranes with different specifications is available commercially, there is a strong need for improvement of membranes selectivity. The main approach to that is to narrow down pore size distribution, which is a challenge for the existing types of ultrafiltration membranes. This multi-phase Small Business Innovation Research project aims to develop and commercialize novel ultrafiltration membranes with unprecedented sharp and controllable molecular-weight cut-off and reduced fouling. Such membranes are needed to fully realize the potential benefits of ultrafiltration in the processing of macromolecules of biological and medical interest. The targeted product - novel membranes - will be suitable as drop-in replacements of the state-of-the- art membranes in commercial membrane holders. The proposed development will drastically improve rapid purification and separation of natural products in biochemical and medical research and in medical care applications and thus is directly relevant to the mission of the National Institute Of General Medical Sciences. The main Phase I objective is to demonstrate feasibility of the proposed approach by fabricating and testing ultrafiltration membranes and confirming their enhanced performance versus commercial analogs. To ensure successful Phase II product development and Phase III commercialization, an early partnership has been secured with a developer of low-cost non-invasive glucose sensors. PUBLIC HEALTH RELEVANCE: The project addresses a significant problem in biomedical research and medical care: rapid size-based purification and separation of macromolecules, including proteins, nucleic acids and polysaccharides. The development of novel advanced ultrafiltration membranes with unprecedented sharp and controllable molecular-weight cut-off and reduced fouling is proposed. The proposed technology will enable a novel family of high-performance membranes for use in biochemical analysis, laboratory studies, and, potentially, in hemodialysis for treatment of end-stage renal failure and in open heart surgery for blood oxygenation.