SBIR Phase II: Removing the Purification Bottleneck in Biopharmaceutical Production

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to remove the purification bottleneck in biopharmaceutical production. Protein engineering has enabled the new experiments to better understand the molecular basis of disease and to aid in the discovery of new biopharmaceuticals. However, low-cost purification of the protein of interest from thousands of other proteins remains a challenge. Access to inexpensive proteins for study will accelerate drug discovery with an estimated 10x savings. The proposed project will optimize development at scale. The proposed project will advance the translation of a suite of protein purification solutions at various operational scales. The proposed project will optimize a research-scale kit for recombinant protein purification for an estimated eighty percent of the purifications performed in research today. Specialized kits for high yield and purity will be developed for the remaining twenty percent. Enzymes used to remove an affinity tag from the protein of interest after it has been purified will be developed at scale. 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.