Technology Holding, LLC — Department of Defense STTR Phase II: AF15-AT29

Description

Elimination of the cold chain is of vital importance for the ability to treat injured warfighters in the field and behind enemy lines. The application of an already FDA approved reagent for the stabilization of labile reagents will allow for minimal development time delaying the fielding of a new technology to fill this role. Protein polymers have been used extensively since the 1980s as an approved injectable by the FDA. Further, protein polymer derivatives are classified as being generally recognized as safe (GRAS) allowing for the development of both oral and injectable formulations. Previously other protein polymers, namely silks, have shown the ability to increase the stability of vaccines and antibiotics when formulated into films and silk-elastinlike protein polymers have shown the ability to increase duration of activity of implanted viruses. In this application we propose the further the use of protein polymers for stabilization of labile reagents and design a cGMP scale up process for an FDA approvable manufacturing process.