SBIR Phase I: A New Class of Immobilized Metal Affinity Chromatography Resins

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project will be to develop protein purification nanotechnology and materials for biopharmaceutical applications. Over 150 different protein or small peptide-based drugs have received FDA approval to treat an array of diseases (e.g., biologics, monoclonal antibodies, and blood clotting factors). Protein purification remains a challenge as the number of synthetic peptides entering clinical trials continues to grow. The global protein and peptide drug market is projected to exceed $140 billion in 2017 with an annual growth rate of ~5%. Demonstration of the feasibility of the proposed new protein purification resins is expected to provide a transformational tool for drug research and development, enhance research in protein/peptide structure and function, and enable the discovery of new proteins/peptides. This SBIR Phase I project proposes to develop and commercialize new protein purification resins based on nanomaterials that will afford capacity independent of protein size, minimal metal leaching, and better stability with respect to existing immobilized metal affinity chromatography (IMAC) resins for protein purification. The new resins will ensure greater purity and activity of isolated proteins with control of epitope-tag specificity, and minimize non-specific interactions. The new resins will be compatible with current manufacturing processes and applicable in batch, microplate, sensor chip, and column formats. The goal is to demonstrate that the proposed technology is superior to existing commercial resins, as suggested by theoretical predictions and preliminary results. The new IMAC resins will be synthesized and characterized in terms of metal content and leaching, protein loading capacity, purity and activity of proteins isolated, and stability. These resins will be optimized for each mode of operation. The goal is to establish a new platform technology for analytic and preparative drug protein isolation.