Nanostructured Ultrafiltration Membranes for Biological Applications

描述（由申请人提供）：该多阶段SBIR项目针对国家普通医学科学研究所使命内的一个重要问题：大分子（包括蛋白质、核酸和多糖）的快速基于尺寸的纯化和分离。主要目标是开发具有前所未有的尖锐且可控的分子量截止（MWCO）并减少污染的新型超滤膜。需要这样的膜来充分实现超滤（UF）的潜在益处，从而解决生物化学和医学研究、医疗护理、生物分析和生物制造中的各种迫切需求。Synkera旨在通过开发和商业化由自组织纳米多孔陶瓷制成的膜来应对这一挑战，该陶瓷具有几乎单分散的纳米级孔。这种方法的核心是Synkera前所未有的能力，可以将膜孔径精确调整到0.5-150 nm范围内的任何值，这在第一阶段中被证明是可行的。第一阶段的所有关键目标都已实现或超额完成。Synkera首次制造了这种膜的原型，并证明了其与商业膜相比的上级性能。一个明显的突破性机会现在是开放的，以开发一个全新的家庭超滤膜的各种应用与巨大的市场潜力和技术，经济和健康效益的最终用户，消费者和患者。新膜不仅为已建立的UF用途提供了性能改进，而且Synkera膜的先进结构和无与伦比的结构控制也可能使新的突破性应用成为可能，例如复杂高分子混合物的分馏。为了充分挖掘这项技术的潜力，Synkera与多个学术和工业合作伙伴建立了合作研发。基于所提出的技术的近期产品包括优于当前可用的膜的平面UF过滤器，以及特定应用的膜（例如，用于蛋白质分离）和生物分析基质（例如，用于葡萄糖感测）。通过与生物医学耗材OEM制造商合作，我们还将开发和商业化离心机、注射器和在线过滤器、滤芯、多孔板插入物和UF模块。第二阶段的主要目标是对膜技术进行系统的开发，以满足不同应用的要求，并将其提升到一个成熟的水平，从而实现廉价而高性能的膜和衍生产品。 公共卫生相关性：该项目解决了生物医学研究和医疗保健中的一个重要问题：基于大小的快速纯化和分离大分子，包括蛋白质，核酸和多糖。提出了开发具有前所未有的尖锐和可控的分子量截止和减少污染的新型先进超滤膜的建议。拟议的技术将使一个新的家庭的高性能膜用于生化分析，实验室研究，并可能在血液透析治疗终末期肾功能衰竭和心脏直视手术的血液氧合。

DESCRIPTION (provided by applicant): This multi-phase SBIR project targets a significant problem within the mission of the National Institute of General Medical Sciences: rapid size-based purification and separation of macromolecules, including proteins, nucleic acids and polysaccharides. The main objective is to develop novel ultrafiltration membranes with unprecedented sharp and controllable molecular-weight cut-off (MWCO) and reduced fouling. Such membranes are needed to fully realize the potential benefits of ultrafiltration (UF) and thereby address various pressing needs in biochemical and medical research, medical care, bioanalysis and biomanufacturing. Synkera aims to addresses this challenge by developing and commercializing membranes made from self-organized nanoporous ceramic with practically monodisperse nanometer-scale pores. At the core of this approach, which was proven feasible in Phase I, is Synkera's unprecedented ability to precisely tune the membrane pore diameter to any value in the 0.5-150 nm range. All the key Phase I objectives have been met or exceeded. For the first time, Synkera fabricated prototypes of such membranes and demonstrated their superior performance in comparison with commercial membranes. A clear breakthrough opportunity is now open to develop a whole new family of UF membranes for a variety of applications with enormous market potential and technical, economical, and health benefits to the end users, consumers and patients. Not only do the new membranes offer a performance improvement for established UF uses, but the advanced architecture and unrivaled control of the structure of Synkera's membranes also potentially enable new breakthrough applications such as fractionation of complex macromolecule mixtures. To fully explore the potential of this technology, Synkera established collaborative R&D with several academic and industrial partners. The near-term products based on the proposed technology include planar UF filters that outperform currently available membranes, as well as application-specific membranes (e.g., for protein separation) and bioanalysis substrates (e.g., for glucose sensing). In partnership with OEM manufacturers of biomedical consumables, we will also develop and commercialize centrifuge, syringe and in-line filters, filter cartridges, multiwell-plate inserts, and UF modules. The main objective of Phase II is now to perform a systematic development of the membrane technology to meet the requirements of different applications, and advance it to a readiness level that enables inexpensive yet high-performance membranes and derivative products. 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.