SBIR Phase I: Rapid Gel Microarrays for Low-cost Protein Binding Assays

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力将是开发快速和定制的蛋白质测试的新工具。这项拟议的技术将允许最终用户快速设计他们自己的高通量阵列，将分析时间从几天或几周减少到几分钟。此外，与目前的表面固定底物，如蛋白质微阵列、酶联免疫吸附试验和基于微珠的系统相比，所提出的3D水凝胶反应环境有望改善结合相互作用和灵敏度。今天，蛋白质微阵列市场由销售预制图案阵列的公司和提供昂贵的定制阵列服务的实验室主导。拟议的技术将有可能转变和推动蛋白质微阵列测量的广泛采用，进入更广泛的生命科学研究应用，范围从高通量药物研究和抗体开发到定制的个性化药物。此外，这项变革性的技术承诺提高定制化和速度，同时降低成本，使高精度蛋白质测试成为常规，并可在价值7.82亿美元的研究和诊断市场中使用。这个SBIR项目旨在开发一个快速、多路复用的蛋白质测试平台，该平台易于定制，并可由第三方用户运行。目前的蛋白质微阵列可以分析单个样本中的靶标，以对抗数百个表面固定的捕获分子。然而，阻碍传统蛋白质微阵列广泛采用的问题包括成本高、检测时间长，或者缺乏定制化、样品多重化和特异性。拟议的电动凝胶微阵列(EGM)技术将通过集成在微流控体系结构中的功能化水凝胶的核心进步，使用户能够在邮票大小的芯片上对数十到数百种用户定制的分析物进行模式和测试，从而超越这些障碍。第一阶段的目标是设计和测试关键的EGM技术，证明在具有3D水凝胶架构的微型设备上开发可定制的15分钟蛋白质配体阵列的可行性。这些功能化的凝胶将允许高效的均相蛋白质相互作用，同时显著增强传统的异质表面固定阵列的结合环境。第一阶段的任务将包括开发基于凝胶的蛋白质捕获系统，优化分析和光学读出方案，验证模型蛋白质系统的定量测量，以及设计分析微流控芯片。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be to develop new tools for rapid and customized protein testing. The proposed technology would allow the end user to rapidly pattern their own high-throughput arrays, reducing assay time from days or weeks to minutes. In addition, the proposed 3D hydrogel reaction environment is expected to improve binding interactions and sensitivity compared with the current surface immobilized substrates, such as protein microarrays, ELISA, and bead-based systems. Today, the protein microarray market is dominated by companies selling pre-patterned arrays, and labs providing costly customized array services. The proposed technology will have the potential to transform and advance the widespread adoption of protein microarray measurements into broader life science research applications ranging from high-throughput pharmaceutical research and antibody development to customized personalized medicine. In addition, this transformational technology promises to improve customization and speed while driving down costs, making high accuracy protein testing routine and accessible within the $782M research and diagnostics market. This SBIR project aims to develop a rapid and multiplexed protein testing platform to be easily customized and run by third-party users. Current protein microarrays can analyze targets from a single sample against hundreds of surface-immobilized capture molecules. However, problems preventing widespread adoption of traditional protein microarrays include high costs, long assay times, or a lack of customization, sample multiplexing, and specificity. The proposed Electrokinetic Gel Microarray (EGM) technology will surpass these barriers through core advances in functionalized hydrogels integrated within microfluidic architectures that could allow a user to pattern and test tens to hundreds of user-customized analytes on a postage stamp-sized chip. The Phase I goal is to design and test key EGM technology that proves feasibility of developing a customizable 15 minute protein-ligand array on a microdevice with a 3D hydrogel architecture. These functionalized gels will allow for efficient homogeneous protein interactions while significantly enhancing the binding environment over traditional heterogeneous surface-immobilized arrays. Phase I tasks will include developing a gel-based protein capture system, optimizing assay and optical readout protocols, validating quantitative measurement of a model protein system, and designing the assay microfluidic chips.