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

这个小企业技术转让（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，为药物配制和交付的国际市场服务。通过提供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影响。此外，该解决方案将大大减少运输过程中温度控制不足造成的药品浪费，每年可节省350亿美元。通过提供冷链物流的替代方案，该技术将推动药物配方和分销的经济效益，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、质量和可用性，从而促进疫苗免疫计划，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。这是一种室温脱水工艺，可提高生物制药的热稳定性，并避免冷链供应的需要。冷链破坏与疫苗可预防的疾病甚至免疫接种后的不良事件有关，一项研究报告称，7%的接种温度受损疫苗的患者出现了健康问题（其中15%的健康问题被认为是严重的）。脱水是一种已知的热稳定方法，但目前的干燥技术是耗时的，可扩展性差，能量效率低，并且由于施加高应力而具有潜在的破坏性。该项目的重点是疫苗运输和储存解决方案配方的热稳定性。该研究和开发确立了快速室温气溶胶脱水（RSDG）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。研究了两大类生物分子在蛋白质和核酸中的应用。将证明脱水制剂的质量和化学/生物完整性。此外，生物药物将以可控的方式微胶囊化。这一努力将提供概念验证，支持进一步的RISK技术发展。该奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.