I-Corps: Towards Thermally Stable Formulations

I-Corps项目的更广泛影响/商业潜力涉及温度敏感制剂的稳定。对温度敏感的制剂，如蛋白质药物和疫苗，需要昂贵的冷链运输和储存。这一要求不仅给这些产品带来了巨大的成本和质量挑战，而且在极端环境或某些地区可能无法满足。这一未满足的需求可能会限制救生药物的使用。实现冷链外的运输和/或储存将解决这些问题，具有重要的商业市场和利益。这个I-Corps项目的重点是一种实现热稳定配方的技术。这种基于冰结合多肽（IBP）平台的创新多功能技术特别适用于IBP在热稳定和碳水化合物结晶控制中以前未解决的作用，以使热敏制剂/产品在运输和储存期间稳定。IBP稳定技术可以在广泛的温度范围内有效地稳定温度敏感蛋白质和制剂，这最终可能使这些制剂能够在冷链外运输和储存。最终目标是使用IBP稳定技术实现温度敏感配方/产品的无冷链运输和储存。具体而言，NSF I-Corps项目的目标是通过广泛的客户访谈了解市场需求，确定理想客户，并开发满足客户需求的IBP稳定技术。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project involves the stabilization of temperature-sensitive formulations. Temperature-sensitive formulations, such as protein drugs and vaccines, require costly cold-chains for the transportation and storage. This requirement not only poses significant costs and great quality challenges for these products, but also may not be fulfilled under extreme environments or in certain regions. This unmet need may consequently limit the use of life-saving drugs. Enabling transportation and/or storage outside cold chains will resolve these problems having significant commercial markets and benefits. This I-Corps project is focused on a technology towards thermally stable formulations. This innovative, multifunctional technology based on ice-binding polypeptide (IBP) platforms, in particular, applies previously unaddressed roles of IBP in thermal stabilization and carbohydrate crystallization controls to enable the stabilization of heat sensitive formulations/products during transportation and storage. The IBP stabilization technology can efficiently stabilize temperature-sensitive proteins and formulations under a wide range of temperatures, which may eventually enable the transportation and storage of these formulations outside cold chains. The ultimate goal is to enable cold-chain free transportation and storage of temperature sensitive formulations/products using the IBP stabilization technology. Specifically, the goals in this NSF I-Corps project are to understand the market needs by extensive customer interviews, to identify ideal customers, and to develop IBP stabilization technology to fit the identified customers' needs.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.