STTR Phase I: Rapid Dehydration and Stabilization of Biopharmaceutical Formulations at Room Temperature

这项小企业技术转让（STTR）第一阶段项目的更广泛影响是，通过允许制药行业避免困扰传统冷链系统的关键漏洞，为药物配方和交付的国际市场提供服务。通过提供一个强大的热稳定解决方案，该技术将对人口健康和免疫产生深远的影响。此外，该解决方案将大大减少由于运输过程中温度控制不足而造成的药品浪费，每年可节省相当于350亿美元的费用。通过提供冷链物流的替代方案，该技术将为药物配方和分销带来经济效益，巩固美国作为全球制药行业创新者和关键的地位。这种稳定生物制药配方的创新方法将提高重要药物的安全性、可靠性、质量和可获得性，从而促进疫苗免疫规划，延长生物制剂和疫苗的安全保质期，减少产品浪费、碳足迹以及药物运输和储存对环境的影响。该项目旨在建立一个创新的。室温脱水过程，提高了生物制药的热稳定性，避免了冷链供应的需要。冷链断裂与疫苗可预防疾病的病例甚至免疫接种后的不良事件有关，一项研究报告说，接种温度降低疫苗的患者中有7%出现健康问题（其中15%被认为是严重的健康问题）。脱水是一种已知的热稳定方法，但目前的干燥技术耗时长，可扩展性差，能源效率低，并且由于应用高应力而具有潜在的破坏性。该项目侧重于疫苗运输和储存解决方案配方的热稳定。该研究和开发建立了快速室温气溶胶脱水（RTAD）的有效性，可靠性和适用性，作为各种生物药物分子脱水的商业前景平台。研究了RTAD在蛋白质和核酸中的应用，包括两大类生物分子。将展示脱水配方的质量和化学/生物完整性。此外，生物药物将以可控的方式被微胶囊化。这项工作将为进一步的RTAD技术开发提供概念证明。该奖项反映了美国国家科学基金会的法定使命，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 of this Small Business Technology Transfer (STTR) Phase I project is to serve international markets in drug formulation and delivery by allowing the pharmaceutical industry to avoid the critical vulnerabilities that plague traditional cold chain systems. By offering a robust solution for thermal stabilization, the technology will have far-reaching effects on population health and immunization. Additionally, the solution will substantially reduce the wastage of pharmaceuticals caused by inadequate temperature control during transportation, resulting in an annual equivalent of $35 billion. By providing an alternative to cold chain logistics, the technology will drive economic benefits in both pharmaceutical formulation and distribution, cementing the position of the US as an innovator and linchpin of the global pharmaceutical industry. This innovative method for the stabilization of biopharmaceutical formulations will improve the safety, reliability, quality, and availability of vital medicines that will facilitate vaccine immunization programs, prolong the safe shelf-life of biologics and vaccines, and reduce product wastage, the carbon footprint, and environmental impacts of pharmaceutical transportation and storage.This project seeks to establish an innovative. room-temperature dehydration process that improves the thermal stability of biopharmaceuticals and circumvents the need for a cold chain supply. Cold chain breach has been associated with cases of vaccine-preventable disease or even adverse events following immunization, with one study reporting health issues suffered by 7% of patients administered with temperature-compromised vaccines (15% of these health issues were considered serious). Dehydration is a known thermal stabilization method, but current drying technologies are time-consuming, poorly scalable, energy inefficient, and potentially destructive due to the application of high stresses. This project focuses on thermal stabilization of formulation for robust vaccine transportation and storage solutions. The research and development establishes the efficacy, reliability, and applicability of rapid Room Temperature Aerosol Dehydration (RTAD) as a commercially promising platform for the dehydration of various biologic drug molecules. The application of RTAD to proteins and nucleic acids is investigated with two major classes of biological molecules. The quality and chemical/biological integrity of the dehydrated formulations will be demonstrated. Also, the biopharmaceuticals will be microencapsulated in a controllable manner. This effort will provide proof of concept supporting further RTAD technology development.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.