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

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.