SBIR Phase II: Microglassification: Dehydration Process for Protein Preservation

This Small Business Innovation Research (SBIR) Phase II project will advance the recent discovery of an ambient temperature dehydration method ""Microglassification"" that is designed to more efficiently stabilize biomolecules for preservation. Lyophilization is the current process of choice, but it has major disadvantages including high capital cost of equipment, high energy costs, and long process time. Furthermore, with the advent of new protein therapeutics, diagnostics, vaccines, such expensive and environment-sensitive biomolecules can be irreversibly impacted due to the stresses of the freezing and the drying process and may never reach the market due to insufficient stability or even degradation that makes them antigenic and toxic in the body. Incorporation of Microglassification to produce a dry formulation of a biomolecule leads to following benefits: reduction in operation costs, production time savings, increased yield and purity, increased long-term stability, and reduced capital equipment costs. The broader impacts of this research are not limited to broader temperature tolerances for the microglassified products facilitating storage and transport of sensitive biologics throughout the US, and also to developing countries. But also this research furthers the fundamental understanding of water removal from a protein (how molecular layers of water of hydration influence protein activity), the structural changes that might occur in the protein, and the protein interactions with its surrounding environment. It is expected that Microglassification will provide the needed stability to enable a biotechnological advance to reach the market, and, more importantly, reach the patient.