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

SBIR 第一阶段：开发基于聚合物凝胶的指示器，以监测单个疫苗瓶暴露于有害温度的情况

• 批准号: 1315511
• 负责人: Bani Cipriano
• 金额: $ 15万
• 依托单位: Prasidiux LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2013-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1315511&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Polymer; Gel

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.

该小型企业创新研究I期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。如果暴露于低于阈值温度的低温（即冷冻）并且如果暴露时间超过规定的降解时间，某些疫苗会遭受不可逆的效力损失。我们的TTI产品将通过采用聚合物水凝胶提供此类有害事件的指示，该聚合物水凝胶由于温度低于临界体积转变温度而经历体积变化。通过设计凝胶转变温度以匹配疫苗阈值温度，TTI能够指示暴露于有害温度。此外，由于存在与凝胶体积的塌陷相关联的时间，因此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通常很差，但很重要，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将使用I期资金开发用于TTI产品的水凝胶配方。该项目的一个主要目的是开发在凝胶转变温度下具有高重现性的制剂。该项目更广泛的影响/商业潜力是解决疫苗冷供应链缺陷引起的商业和社会问题。在美国，最近的一项研究显示，医生？76%的办事处没有妥善储存对温度敏感的疫苗。由于当前监测技术的缺点，疫苗温度的监测是在托盘运输水平上进行的。因此，接受或拒绝暴露于有害温度的疫苗的决定是基于有限的数据，并且完全可行的疫苗通常会被丢弃。建议的TTI将允许知情决定使用或丢弃疫苗。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，由于暴露于有害温度而导致的疫苗效力损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，完成本项目的目标将推进聚合物水凝胶领域的知识。