SBIR Phase I: Microglassification: Dehydration Process for Protein Preservation

This Small Business Innovation Research (SBIR) Phase I project develops a new method for preserving proteins by a Microglassification Process that controllably dehydrates proteins into microspheres. This process has the potential to stabilize proteins by removing water to a level that does not allow microorganisms to grow and without heating or cooling, effectively preserving the protein at room temperature. Proteins are an important class of molecules in medicine that are used to diagnose, prevent and treat diseases or to restore (maintain) normal body functions. This research tests some model proteins that are in common laboratory and/or clinical use, and this process will be compared to the current state-of-the-art process of freeze-drying. The goal of this feasibility study is to develop a new industrial process that avoids the damage of the freezedrying process yet preserves protein in a stabilized form at ambient temperature as a partially dehydrated microsphere product. After feasibility for the new Microglassification Process is shown, the company plans to develop methods for customizing it for use with specific molecules of commercial importance with corporate strategic partners who are manufacturers of biologicals. The company plans to develop a new molecule preservation business that can derive revenue via process licenses to customers involved in production as well generating revenue through process customization contracts. In addition, licenses could also be provided to selected equipment manufacturers who are designated as providers of process equipment as well as selected manufacturers of process supplies. The broader impact of this technology will be improved preservation of sensitive biologicals important to the bioscience and biomedical marketplace.