SBIR-STTR Award

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.

The broader impact/commercial potential of this Small Business Innovation Research Phase (SBIR) II project is to help detect whether pharmaceuticals about to be administered to patients have been damaged during shipment or storage by exposure to very cold temperatures close to or below the freezing temperature of water. Many pharmaceuticals, especially vaccines, lose their potency if exposed to near-freezing conditions. In light of tightening regulations with respect to the temperature-controlled storage and distribution of pharmaceuticals and changing distribution models (increase in direct-to-patient shipments), there is a critical need to demonstrate with greater reliability and in a cost-effective manner whether pharmaceuticals lose their potency due to exposure to harmful temperatures. The result of this SBIR II project will be an indicator that will provide workers along the pharmaceutical supply chain information about whether a pharmaceutical encountered harmful temperatures and the duration of such an encounter. Both harmful temperature and duration of exposure are critical pieces of data required to determine whether a pharmaceutical has been compromised. Technologies do exist that indicate whether an exposure to a harmful temperature has occurred, however, the indication of time of exposure is muddled and difficult to discern. The proposed research in this Phase II SBIR program, if successful, will offer a reliable alternative to costly electronic devices. The benefits of this device include preventing damaged product from reaching patients, helping companies remain in compliance with regulations in a cost-effective manner and reducing pharmaceutical waste.This Small Business Innovation Research Phase II project aims to develop Time Temperature Indicators (TTIs) that reliably indicate exposure of pharmaceutical shipments to harmful cold temperatures near the freezing point of water. This technology will be the first chemical-based technology capable of indicating the duration of such exposures. If a harmful exposure occurs, the combination of time and temperature data provided by these indicators can be used by the shipper to evaluate whether a pharmaceutical was truly compromised. As a result, pharmaceuticals that have been truly compromised are discarded and not administered to the patient. The patented indicators utilize a specially formulated polymer hydrogel that undergoes a volume transition from a swollen to a collapsed state upon cooling. The kinetics and the temperature dependence of the transition are highly tunable. The objectives of this Phase II project include refining formulations and synthesis methods to prepare polymer gels with highly reliable swollen-shrunken transitions. These gels will then be incorporated into specially designed housings to obtain TTI prototypes. Simple manual-driven machines will be designed to prepare the TTI prototypes. The performance of these TTIs will be validated: the company will demonstrate that these TTIs meet a minimum quality requirement. Thereafter the project will test the stability of the TTIs by measuring performance after accelerated storage and the proposed TTI prototypes will be subjected to standard transit tests. As the reliability of these indicators is a key product attribute, this project will identify the synthesis and process steps that introduce variability and address them accordingly.