Enabling Nanomembrane-Based Biomolecule and Nanoparticle Separations

实现基于纳米膜的生物分子和纳米颗粒分离

• 批准号: 9045849
• 负责人: James L McGrath
• 金额: $ 19.89万
• 依托单位: SIMPORE, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-19 至 2018-01-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9045849
• 关键词: Academia; Antibodies; Area; Biological Sciences; Biotechnology; Buffers; Caliber; Centrifugation; Complex; Custom; Data; Development; Devices; Diagnostics Research; Dialysis procedure; Drug Delivery Systems; Goals; Housing; Immunoglobulin G; Laboratories; Letters; Manufacturer Name; Marketing; Membrane; Methods; Molecular; Molecular Sieve Chromatography; Pain; Particle Size; Performance; Permeability; Phase; Polymers; Polystyrenes; Preparation; Proteins; Quantum Dots; Reporting; Resort; Sampling; Scheme; Scientist; Silicon; Small Business Technology Transfer Research; Specificity; Speed; Surface; Techniques; Technology; Testing; Time; Tissues; Tube; Universities; antibody conjugate; base; biomedical scientist; design; drug development; experience; in vivo imaging; innovation; meetings; nanomembrane; nanoparticle; particle; product development; professor; prototype; public health relevance; solute; tool

 DESCRIPTION (provided by applicant): The global market for nanoparticles (NP) in biotechnology, drug development and drug delivery was estimated to be $20B for 2013 and is expected to reach more than $50B by 2017. The two most active areas of product development are NPs for drug delivery and for in vivo imaging. In these applications it is often critical that he outer surfaces of NPs are functionalized with antibodies (Ab) that target them to specific tissues After functionalizing NPs with Abs, it is necessary to remove unbound Ab from the NP preparation because any free Ab will compete with the NPs for target tissues. Given the similar sizes of Ab (~ 14 nm) and NPs, this ubiquitous clean-up step is challenging and represents a current pain in the market place. Both academic and industrial NP scientists report that existing polymer- based membranes are not capable of performing this separation and that they must resort to more time-consuming, complex, and lower yield techniques such as size-exclusion chromatography or dialysis. Membrane-based methods are preferred because of their simplicity, efficiency and scalability. In this proposal, we will realize a near-term, straight-forward produc development opportunity that will result in a solution to the NP-Ab separation problem. Using SiMPore's nanomembranes in a custom centrifuge configuration, we have recently shown the ability to separate Ab from 20 nm polystyrene particles. Additional innovations in membrane fabrication and non-fouling coatings will allow us to pursue the following goals: 1) to develop and evaluate a SiMPore product prototype based on our preliminary custom centrifuge concept, 2) to produce a sufficient number of prototypes to enable beta- testing at two major life science tool suppliers, and 3) to introduce a validated product upon completion of this 9-month Phase I project.

 描述(申请人提供)：生物技术、药物开发和药物输送领域的纳米颗粒(NP)的全球市场在2013年估计为200亿美元，预计到2017年将达到500亿美元以上。产品开发中最活跃的两个领域是用于药物输送和体内成像的纳米颗粒。在这些应用中，通常至关重要的是用抗体(Ab)对NPs的外表面进行功能化，使其针对特定的组织。在用Abs功能化NPs后，有必要从NP制剂中去除未结合的Ab，因为任何游离的Ab都会与NPs竞争靶组织。鉴于抗体(~14 nm)和纳米粒子的大小相似，这一无处不在的清理步骤具有挑战性，并代表着目前市场上的痛苦。学术和工业NP科学家都报告说，现有的基于聚合物的膜不能进行这种分离，他们必须求助于更耗时、更复杂和产量更低的技术，如尺寸排除层析或透析。基于膜的方法因其简单、高效和可伸缩性而成为首选方法。在这项提议中，我们将实现一个近期的、直接的生产发展机会，这将导致NP-Ab分离问题的解决。在定制的离心机fi配置中使用SIMPOLE的纳米膜，我们最近已经展示了从20纳米聚苯乙烯颗粒中分离抗体的能力。膜制造和无污染涂层方面的其他创新将使我们能够实现以下目标：1)基于我们初步的定制离心机概念开发和评估SIMPore产品原型，2)生产足够数量的原型，以便能够在两家主要生命科学工具供应商进行Beta测试，以及3)在这个为期9个月的第一阶段项目完成后推出经过验证的产品。