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.

该创新合作伙伴关系 - 技术转化 (PFI-TT) 项目的更广泛影响/商业潜力是缓解大容量注射液 (LVPS) 的药物短缺，例如电解质替代品、静脉输液和透析解决方案。二十年来，美国药品短缺已成为一个不受欢迎的现实，对公共健康和国家安全产生影响。最近对 719 名卫生系统药剂师进行的调查显示，所有人都报告在上一年经历了药品短缺。 81% 的受访者表示，52% 的短缺问题是囤积可用供应，目前缓解药物短缺的策略主要侧重于反应和恢复，而不是做好准备。作为 LVPS 的替代供应药物，除了确保长期的弹性外，该技术还有可能在灾难情况、军事/战区、资源匮乏的环境或其他需要模块化解决方案的环境中产生重要的解决方案。需要且干净该项目还将为首席研究生提供参加学生推介竞赛、价值主张设计课程、领导力研讨会以及定期与团队商业化和监管专家会面的机会。技术创新，可在医院和药房的护理点附近生成注射用水 (WFI)，将 WFI 与浓缩物混合，并在内置环境污染控制中进行无菌、无热原包装，从而无需大多数 LVPS 的体积百分比超过 95%，因此拟议的创新可显着降低与在世界范围内运输“水”相关的成本和能源。该 PFI-TT 奖项将使实施成为可能。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，并验证系统在非清洁环境中满足成分和微生物稳定性要求的能力房间该项目的目标包括完成初级水处理系统的设计，以符合法规要求并降低生物污染风险，并展示满足生产率、成分和微生物稳定性成功标准的全系统可行性。通过在一个具有代表性的 LVPS（含 2.5% 葡萄糖的 Dianeal PD-2）的生产中集成和验证所有三个模块，Daneal PD-2 是在 140 多个客户发现访谈后选择的一种常见腹膜透析处方。该奖项反映了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，NSF 的法定使命被认为值得支持。