SBIR Phase II: Next-Generation Capillary Electrophoresis with Mass Spectrometry for Biopharmaceutical and Biomedical Applications

这项小企业创新研究（SBIR）第二阶段项目的更广泛影响将是开发一种用于生物研究、生物医学研究和生物制药药物开发的新仪器。毛细管电泳（CE）是一项强大的生物分析技术，具有巨大的应用潜力。它是完成人类基因组计划的主力工具，促成了DNA测序革命。该技术将通过提高产品表征的效率来改善质量，从而为生物制药药物开发公司带来好处。这个新系统可能会在药物开发、早期诊断以及癌症、糖尿病和神经退行性疾病等致命人类疾病的治疗方面取得突破。这项技术不仅在生物制药和生化研究市场上有价值，而且在食品、临床和环境分析方面也有价值。该项目将开发下一代毛细管电泳与电喷雾电离质谱（CE-ESI-MS）用于蛋白质表征。CE-ESI-MS可以有效地分离和表征几种生化物质，包括蛋白质。CE-ESI-MS技术将开发为易于使用。它将使用一种新型的流体纳米孔进行样品和缓冲操作，以允许从1微升或更小的体积分析小样品。此外，该仪器将利用集成光学检测的新型电喷雾电离接口。将CE的超高效率与光学检测和质谱分子鉴定的强大定量特性相结合，将成为生物分析的有力工具。这种组合可能代表了最先进技术的重大进步，并增强了在生物样品中询问蛋白质及其生化功能的手段。该技术具有简单的自动化设计和易于使用的特点，可以显著提高CE-ESI-MS的鲁棒性和能力，实现快速、高效和深入的生物分析。该奖项反映了美国国家科学基金会的法定使命，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 of this Small Business Innovation Research (SBIR) Phase II project will be the development of a new instrument for biological research, biomedical research, and biopharmaceutical drug development. Capillary electrophoresis (CE) is a powerful technology with great potential for bioanalysis. It was the workhorse tool for the completion of human genome project that contributed to the DNA sequencing revolution. The technology will offer benefits to biopharmaceutical drug development companies by increasing the efficiency of product characterization for quality improvement. This new system could lead to breakthroughs in drug development, early diagnosis, and treatments for deadly human diseases such as cancer, diabetes, and neurodegenerative disorders. The technology may be of value not only in biopharmaceutical and biochemical research markets but also in food, clinical, and environmental analyses.The project will develop a next-generation capillary electrophoresis with electrospray ionization mass spectrometry (CE-ESI-MS) for protein characterization. CE-ESI-MS allows efficient separation and characterization of several biochemical species, including proteins. The CE-ESI-MS technology will be developed for ease of use. It will use a novel fluidic nanoport for sample and buffer manipulation to allow analysis from 1 microliter or less volume for small samples. In addition, the instrument will utilize a novel electrospray ionization interface with integrated optical detection. Combining CE's ultrahigh efficiency with robust quantitative characteristics of optical detection and the molecular identification of mass spectrometry will be a powerful tool for bioanalysis. This combination may represent a significant advancement over the state-of-the-art and enhance the means of interrogating proteins and their biochemical functions in biological samples. With simple automated design and ease of use, the technology may significantly enhance the robustness and capabilities of CE-ESI-MS for fast, efficient, and deep bioanalysis.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.