SBIR Phase II: High-Throughput and Scalable Nanoparticle Characterization for Life Sciences Applications

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是开发一个仪器平台，该平台将促进基于一类称为细胞外囊泡（EV）的纳米囊泡的下一代诊断和治疗的开发和翻译。EV是由细胞脱落的纳米颗粒，正在研究从生物流体中早期检测疾病，包括癌症，心血管疾病和神经退行性疾病，而无需侵入性组织活检。缺乏对EV进行高通量表征的工具和技术限制了翻译。正在开发的平台将使人们能够理解由细胞产生的电动汽车。生命科学中纳米颗粒分析仪器的全球市场估计为59亿美元。作为该市场的一个子集，电动汽车市场正在快速增长，预计未来五年的复合年增长率（CAGR）为47.3%。生物纳米颗粒在生命科学应用中发挥着越来越重要的作用，需要更好、更快、更精确的工具来高通量地表征它们。SBIR二期项目将完成一个仪器平台的开发，以实现细胞外囊泡（EV）的测量和表征。 该平台将包括一个客户可配置的消耗品，消除了昂贵的定制机器人阵列步骤的要求，消除了最终用户采用的障碍，并分散了发现。此外，还将确定耗材的长期有效期。此外，对成像平台的改进将使最小的纳米颗粒可视化，降低平台的复杂性和成本，并提供优于竞争产品的功能优势。该平台将自动化大部分工作流程，减少操作员的动手时间。由此产生的平台将使EV测量的样品体积减少5倍至30倍，检测浓度降低100倍至10，000倍的目标，并通过使用绕过其他技术所需的纯化要求的工作流程来提高通量。这些目标的完成将为从事电动汽车诊断和治疗的研究人员和行业提供一个生命科学研究工具。该奖项反映了NSF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/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to develop an instrument platform that will facilitate development and translation of next generation diagnostics and therapeutics that are based on a class of nanovesicles called extracellular vesicles (EVs). EVs, which are nanoparticles shed by cells, are being investigated for early detection of diseases, including cancer, cardiovascular disease, and neurodegenerative disorders, from biofluids without the need of invasive tissue biopsies. The lack of tools and techniques to perform high-throughput characterization of EVs is limiting translation. The platform under development will enable an understanding EVs produced by cells. The global market for nanoparticle analysis instrumentation in the life sciences is estimated at $5.9 Billion. The EV market, which is a subset of this market, is rapidly growing, with a predicted compound annual growth rate (CAGR) of 47.3% over the next five years. Biological nanoparticles are playing an increasing role in life science applications and better, target-specific, faster tools are needed to characterize them in a high-throughput way.This SBIR Phase II project will complete the development of an instrument platform to enable Extracellular Vesicle (EV) measurements and characterization. The platform will include a customer configurable consumable, eliminating the requirement for an expensive custom robotic arrayer step, removing barriers to end-user adoption and decentralizing discovery. Also, long-term shelf-life of the consumable will be established. In addition, improvements into the imaging platform will enable visualization of the smallest nanoparticles, relaxing the complexity and cost of the platform and providing a functional advantage over competitive offerings. The platform will automate much of the workflow, reducing operator hands-on time. The resulting platform will enable EV measurements with 5X-to-30X less sample volume, detect 100X-to-10,000X less concentrated targets, and increase throughput by using a workflow that bypasses purification requirements needed by other techniques. The completion of these objectives will result in a life science research tool for researchers and industry working on EV-based diagnostics and therapeutics.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.