PFI-TT: Decentralized, On-Demand Production of Dialysis Solutions and Similar Medical Fluids

PFI-TT：透析溶液和类似医用液体的分散式按需生产

• 批准号: 2234509
• 负责人: Natasha Wright
• 金额: $ 24.99万
• 依托单位: University of Minnesota-Twin Cities
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2234509&HistoricalAwards=false
• 关键词: PFI; TT; Decentralized; Demand; Production

The broader impact/commercial potential of this Partnerships for Innovation - Technology Translation (PFI-TT) project is the mitigation of drug shortages involving Large Volume Parenteral Solutions (LVPS), such as electrolyte replacement, intravenous fluid, and dialysis solutions. Over the past two decades, the United States drug shortages have become an unwelcome reality with public health and national security implications. In a recent survey of 719 health system pharmacists, all reported experiencing drug shortages in the preceding year with 52% of the shortages involving LVPS. The main mitigation strategy, reported by 81% of the respondents, was the hoarding of available supply. Current strategies to mitigate drug shortages are mostly focused on reaction and recovery rather than preparedness. There is a critical need for an alternative pharmaceutical supply for LVPS that ensures long-term resilience. Beyond shortages, the technology has the potential to generate vital solutions in disaster situations, in military/war zones, in low-resource settings, or other settings where a modular solution is needed and clean rooms are not available. The project will also provide opportunities for the lead graduate student to participate in student pitch competitions, a value proposition design course, leadership seminars, and regular check-ins with the team’s commercialization and regulatory experts.The proposed project is a technological innovation that generates water-for-injection (WFI) near the point of care, in hospitals and pharmacies, mixes the WFI with concentrates and performs aseptic, pyrogen-free packaging within built-in environmental contamination controls, eliminating the need for use in a cleanroom facility. Most LVPS are over 95% water for injection (WFI) by volume, so the proposed innovation significantly reduces the cost and energy associated with shipping ‘water’ around the world. This PFI-TT award will enable the implementation of the first full system proof-of-concept prototype, capable of on-demand, hospital/pharmacy-scale (100 L/h) production of LVPS and validation of the system’s ability to meet composition and microbiological stability requirements in a non-clean room environment. The aims of the project include finalizing the design of the primary water treatment train to meet regulations and to reduce risk of biological contamination and demonstrating full-system feasibility to meet production rate, composition, and microbiological stability success criteria. Feasibility will be demonstrated by integrating and validating all three modules in the production of one representative LVPS, Dianeal PD-2 with 2.5% Dextrose, a common peritoneal dialysis prescription selected following 140+ customer discovery interviews.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.

这项创新-技术转化伙伴关系（PFI-TT）项目的更广泛影响/商业潜力是缓解涉及大容量静脉注射溶液（LVPS）的药物短缺，如电解质替代、静脉输液和透析溶液。在过去的二十年里，美国的药品短缺已经成为一个不受欢迎的现实，影响着公共卫生和国家安全。在最近对719名卫生系统药剂师进行的一项调查中，所有人都报告在前一年经历过药物短缺，其中52%的短缺涉及LVPS。81%的答复者报告说，主要的缓解战略是囤积现有供应。目前缓解药物短缺的战略主要侧重于反应和恢复，而不是防备。迫切需要为LVPS提供替代药物供应，以确保长期恢复能力。除了短缺之外，该技术还具有在灾害情况、军事/战区、低资源环境或其他需要模块化解决方案且无法获得洁净室的环境中产生重要解决方案的潜力。该项目还将为首席研究生提供机会，参加学生演讲比赛、价值主张设计课程、领导力研讨会，并定期与团队的商业化和监管专家进行交流。拟议的项目是一项技术创新，在医院和药房的护理点附近产生注射用水（WFI），将WFI与浓缩液混合，并在内置的环境污染控制中进行无菌、无热原包装，从而消除了在洁净室设施中使用的需要。大多数LVPS的注入水量（WFI）超过95%，因此拟议的创新大大降低了与世界各地运输“水”相关的成本和能源。该PFI-TT合同将实现第一个完整的系统概念验证原型，能够按需、医院/药房规模（100 L/h）生产LVPS，并验证系统在非洁净室环境中满足成分和微生物稳定性要求的能力。该项目的目标包括完成初级水处理系统的设计，以满足法规要求，降低生物污染的风险，并展示整个系统的可行性，以满足生产率、成分和微生物稳定性的成功标准。通过整合和验证所有三个模块在一种具有代表性的LVPS生产中的可行性，dieal PD-2含2.5%葡萄糖，这是一种常见的腹膜透析处方，经过140多个客户发现访谈后选择。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。