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

这个小型企业创新研究第一阶段项目涉及开发基于聚合物水凝胶的时间温度指示器(TTI)，以监测单个疫苗瓶的温度历史。如果暴露在低于阈值温度(即冰冻)的低温下，并且暴露时间超过规定的降解时间，某些疫苗就会失去不可逆转的效力。我们的TTI产品将通过使用一种聚合物水凝胶来提供此类有害事件的指示，该聚合物水凝胶在温度降至临界体积转变温度以下时会发生体积变化。通过设计凝胶转变温度以匹配疫苗阈值温度，TTI能够指示暴露在有害温度下。此外，由于存在与凝胶体积崩溃相关的时间，TTI可以提供暴露持续时间的指示。值得注意的是，当前TTI技术中的暴露时间指示功能一般较差，但意义重大，因为疫苗在暴露于有害温度后不会立即降解，而是逐渐降解。Prasidiux将利用第一阶段资金开发水凝胶配方，并将其纳入TTI产品。该项目的一个关键目标是开发在凝胶转变温度下具有高重复性的配方。该项目的更广泛的影响/商业潜力是解决疫苗冷链缺陷引起的商业和社会问题。在美国，最近的一项研究揭示了医生？它评估的办公室中，76%的人以不恰当的方式储存了他们拥有的温度敏感疫苗。由于目前监测技术的不足，疫苗温度的监测是在托盘装运的层面上进行的。因此，接受或拒绝疫苗的决定是基于有限的数据，而且完全可行的疫苗往往被丢弃。拟议的TTI将允许知情的决定使用或放弃疫苗。因此，该项目的主要商业价值是保证减少昂贵的疫苗浪费。此外，暴露在有害温度下导致的疫苗效力丧失阻碍了疫苗接种计划预期的健康结果的实现。该项目的主要社会效益是确保患者获得完全可行的疫苗。最后，实现这一项目的目标将促进对聚合物水凝胶领域的了解。

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.