SBIR Phase I: Universal Proteome Sample Preparation Kit Development

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a protein sample preparation kit that eliminates variability and provides researchers with the information they need to find important protein drug targets and biomarkers. The high throughput protein analysis methods of proteomics are having a significant impact on the biotechnology and pharmaceutical industries, from the development of new protein-based drugs to quality control monitoring and biomarker discovery to clinical diagnostics. All proteomics applications require robust, repeatable and automatable sample preparation methods. Currently, however, these methods are not standardized. The lack of the standardization often leads to experimental failure and unreliable results, which may require many rounds of experimental repeats, costing time and money. Standardized protein sample preparation kits will provide significant workflow savings, improve time to market, and accelerate biomarker discovery and drug development. The intellectual merit of this SBIR Phase I project is to develop a universal peptide isolation kit to serve the diverse needs of the proteomics community. Currently, methods for sample preparation typically have more than a dozen steps, are prone to peptide loss and bias, and require more than a day to complete. Through the NSF I-Corps program, it was discovered that more than 70% of researchers in academia and industry are unhappy with current protein sample preparation methods. To address this need, a sample preparation kit that increases the speed and efficiency of peptide sample preparation was developed. The approach differs from current methods in three fundamental ways. First, all manipulations will be done in solution in a single tube with half the number of steps compared to existing protocols. Second, a fast, universal, and reversible chemical tag is employed rather than relying on physical separation, preventing sample loss or bias. Third, a stabilized derivative of trypsin will allow for complete digestion of protein samples followed by efficient removal of intact and fragmented trypsin, preventing contamination. 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.