I-Corps: Towards Thermally Stable Formulations

I-Corps项目的更广泛影响/商业潜力涉及对温度敏感的配方的稳定。对温度敏感的制剂，如蛋白质药物和疫苗，需要昂贵的冷链来运输和储存。这一要求不仅给这些产品带来了巨大的成本和巨大的质量挑战，而且在极端环境或某些地区也可能无法满足。这种未得到满足的需求可能会因此限制救命药物的使用。允许冷链以外的运输和/或储存将解决这些具有重大商业市场和利益的问题。这个i-Corps项目专注于一种热稳定配方的技术。这项基于冰结合多肽(IBP)平台的创新多功能技术尤其应用了IBP在热稳定和碳水化合物结晶控制中先前未解决的作用，使热敏性配方/产品在运输和储存过程中能够稳定下来。IBP稳定技术可以在广泛的温度范围内有效地稳定对温度敏感的蛋白质和配方，这可能最终使这些配方能够在冷链之外运输和储存。最终目标是使用IBP稳定技术实现温度敏感型配方/产品的冷链自由运输和储存。具体地说，NSF I-Corps项目的目标是通过广泛的客户访谈了解市场需求，确定理想的客户，并开发IBP稳定技术以满足确定的客户需求。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.