SBIR Phase I: High-Throughput Nanoparticle Characterization for Life Sciences Applications

这个小型企业创新研究（SBIR）项目的更广泛的影响/商业潜力是开发一种检测技术，使科学家和研究人员能够更好地了解生物流体中循环的生物颗粒。这种更好的理解将导致新的疾病诊断，可以改善患者的治疗效果并降低医疗成本。正在开发的技术允许对外来体进行高通量检测和表征，外来体是由细胞产生并在所有生物流体中释放的纳米囊泡（例如，血液、唾液和尿液）。正在研究外来体用于从生物流体中早期检测疾病，包括癌症、心血管和神经退行性疾病，而不需要侵入性组织活检。 通过简单的血液或尿液检查早期发现疾病，可以在更早的时间点发现疾病，使治疗更有效，并减少对可能导致进一步并发症的昂贵和侵入性程序的需求。此外，正在开发的相同技术也可用于帮助制造使用外泌体对抗癌症，心血管和神经退行性疾病的下一代治疗药物。 该SBIR第一阶段项目提出开发一种客户可配置的盒，该盒将允许定制生物探针，以基于其表面标记物识别和测量特定的外泌体群体。外泌体是由细胞脱落到生物液体中的纳米颗粒（50-200 nm），正在研究用于早期检测疾病，包括癌症、心血管和神经退行性疾病。外泌体具有生物活性，与其他生物标志物相比，可能以高浓度存在，但它们的小尺寸使得它们很难用现有技术表征。该提案旨在创建一个高通量平台，以通过两个开发目标满足外泌体表征要求：1）开发、验证和展示一次性微流体装置，其将允许客户配置用于表征外泌体的特定群体的测定，以及2）能够稳健地检测和鉴定低指数外泌体纳米颗粒的最小群体，低至50 nm，允许在高通量平台中完成外泌体大小测定。这些目标的完成将导致一种产品被出售给研究基于纳米颗粒的诊断和治疗的研究人员。

The broader impact/commercial potential of this Small Business Innovative Research (SBIR) project is to develop a detection technology that enables scientists and researchers to better understand biological particles circulating in biofluids. This improved understanding would lead to new disease diagnostics that could improve patient outcomes and reduce healthcare costs. The technology being developed allows high-throughput detection and characterization of exosomes, which are nanovesicles produced by cells and released in all biological fluids (e.g., blood, saliva, and urine). Exosomes are being investigated for early detection of diseases, including cancer, cardiovascular, and neurodegenerative disorders, from biofluids without the need of invasive tissue biopsies. Early detection of disease from a simple blood or urine test allows discovery of disease at an earlier point making treatments more effective and reduces the need for costly and invasive procedures that could cause further complications. Furthermore, the same technology being developed also may be used to aid in the manufacturing of next-generation therapeutics that use exosomes to combat cancer, cardiovascular and neurodegenerative diseases. This SBIR Phase I project proposes to develop a customer-configurable cartridge that will allow customization of biological probes to identify and measure specific populations of exosomes based on their surface markers. Exosomes, which are nanoparticles (50-200 nm) shed by cells into biological fluids, are being investigated for early detection of diseases, including cancer, cardiovascular, and neurodegenerative disorders. Exosomes, which are biologically active, may be found at high concentrations compared to other biomarkers, but their small size makes them very difficult to characterize with current techniques. This proposal is to create a high-throughput platform to address exosome characterization requirements through two development aims: 1) Develop, validate, and demonstrate a disposable microfluidic device that will allow customers to configure the assay for characterization of specific populations of exosomes, and 2) enable robust detection and identification of the smallest populations of low-index exosome nanoparticles, down to 50 nm, allowing complete exosome sizing in a high-throughput platform. The completion of these objectives will result in a product to be sold to researchers working on nanoparticle-based diagnostics and therapeutics.