STTR Phase I: Rapid Dehydration and Stabilization of Biopharmaceutical Formulations at Room Temperature

Inaedis, Inc, Princeton NJ

Investigators

Abstract

The broader impact of this Small Business Technology Transfer (STTR) Phase I project is to serve international markets in drug formulation and delivery by allowing the pharmaceutical industry to avoid the critical vulnerabilities that plague traditional cold chain systems. By offering a robust solution for thermal stabilization, the technology will have far-reaching effects on population health and immunization. Additionally, the solution will substantially reduce the wastage of pharmaceuticals caused by inadequate temperature control during transportation, resulting in an annual equivalent of $35 billion. By providing an alternative to cold chain logistics, the technology will drive economic benefits in both pharmaceutical formulation and distribution, cementing the position of the US as an innovator and linchpin of the global pharmaceutical industry. This innovative method for the stabilization of biopharmaceutical formulations will improve the safety, reliability, quality, and availability of vital medicines that will facilitate vaccine immunization programs, prolong the safe shelf-life of biologics and vaccines, and reduce product wastage, the carbon footprint, and environmental impacts of pharmaceutical transportation and storage. This project seeks to establish an innovative. room-temperature dehydration process that improves the thermal stability of biopharmaceuticals and circumvents the need for a cold chain supply. Cold chain breach has been associated with cases of vaccine-preventable disease or even adverse events following immunization, with one study reporting health issues suffered by 7% of patients administered with temperature-compromised vaccines (15% of these health issues were considered serious). Dehydration is a known thermal stabilization method, but current drying technologies are time-consuming, poorly scalable, energy inefficient, and potentially destructive due to the application of high stresses. This project focuses on thermal stabilization of formulation for robust vaccine transportation and storage solutions. The research and development establishes the efficacy, reliability, and applicability of rapid Room Temperature Aerosol Dehydration (RTAD) as a commercially promising platform for the dehydration of various biologic drug molecules. The application of RTAD to proteins and nucleic acids is investigated with two major classes of biological molecules. The quality and chemical/biological integrity of the dehydrated formulations will be demonstrated. Also, the biopharmaceuticals will be microencapsulated in a controllable manner. This effort will provide proof of concept supporting further RTAD technology development. 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.