I-Corps: Towards Thermally Stable Formulations

California State L A University Auxiliary Services Inc., Los Angeles CA

Investigators

Abstract

The broader impact/commercial potential of this I-Corps project involves the stabilization of temperature-sensitive formulations. Temperature-sensitive formulations, such as protein drugs and vaccines, require costly cold-chains for the transportation and storage. This requirement not only poses significant costs and great quality challenges for these products, but also may not be fulfilled under extreme environments or in certain regions. This unmet need may consequently limit the use of life-saving drugs. Enabling transportation and/or storage outside cold chains will resolve these problems having significant commercial markets and benefits. This I-Corps project is focused on a technology towards thermally stable formulations. This innovative, multifunctional technology based on ice-binding polypeptide (IBP) platforms, in particular, applies previously unaddressed roles of IBP in thermal stabilization and carbohydrate crystallization controls to enable the stabilization of heat sensitive formulations/products during transportation and storage. The IBP stabilization technology can efficiently stabilize temperature-sensitive proteins and formulations under a wide range of temperatures, which may eventually enable the transportation and storage of these formulations outside cold chains. The ultimate goal is to enable cold-chain free transportation and storage of temperature sensitive formulations/products using the IBP stabilization technology. Specifically, the goals in this NSF I-Corps project are to understand the market needs by extensive customer interviews, to identify ideal customers, and to develop IBP stabilization technology to fit the identified customers' needs. 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.