SBIR Phase I: Development of Polymer Gel-Based Indicators to Monitor the Exposure of Individual Vaccine Vials to Harmful Temperatures

This Small Business Innovation Research Phase I project pertains to the development of polymer hydrogel-based time temperature indicators (TTIs) to monitor the temperature history of individual vaccine vials. Certain vaccines suffer irreversible loss in potency if exposed to cold temperatures below a threshold temperature (i.e. freezing) and if the exposure time exceeds a prescribed degradation time. Our TTI product will provide indication of such harmful events by employing a polymer hydrogel that undergoes a volume change as a result of temperatures dipping below a critical volume transition temperature. By engineering the gel transition temperature to match the vaccine threshold temperature, the TTI is capable of indicating exposure to harmful temperatures. Furthermore, since there is a time associated with the collapse of the gel volume, the TTI can provide indication of duration of the exposure. Notably, the exposure time indication functionality in current TTI technology is generally poor but is significant because vaccines do not degrade instantly but rather gradually after exposure to harmful temperatures. Prasidiux will use Phase I funds to develop formulations for hydrogels to be incorporated into the TTI product. A key aim of this project is to develop formulations with high reproducibility in the gel transition temperature. The broader impact/commercial potential of this project is in addressing commercial and societal problems that arise from deficiencies in the vaccine cold supply chain. In the United States, a recent study revealed that of the doctors? offices it evaluated, 76% had improperly stored the temperature sensitive vaccines in their possession. Due to the shortcomings of current monitoring technologies, the monitoring of vaccine temperature is done at the pallet shipment level. As a result, decisions to accept or reject vaccine as having been exposed to harmful temperatures are based on limited data and fully viable vaccine is often discarded. The proposed TTI will allow the informed decision to use or discard vaccine. Thus, the main commercial value of this project is to guarantee reduction of costly vaccine waste. Furthermore, loss in vaccine potency resulting from exposure to harmful temperatures prevents the realization of health outcomes expected from vaccination programs. The main societal benefit of this project is ensuring that patients receive fully viable vaccines. Finally, accomplishing the aims of this project will advance knowledge in the field of polymer hydrogels.