I-Corps: Device for on-demand manufacturing of large volume parenteral solutions

I-Corps项目的更广泛影响/商业潜力在于，通过在当地分散生产透析液，改善了资源匮乏地区透析解决方案的可及性。部分由于一些国家缺乏当地生产的透析液，透析液的获取有限，导致全球数百万人死亡。进口透析液可能导致高昂的费用，这往往会使肾衰竭患者负担不起至关重要的透析液。这项拟议的技术有可能帮助降低成本，为更多的患者提供更多的机会，同时也提高了供应商的盈利能力。除了全球肾脏护理之外，该技术在其他必要的大容量非肠外溶液中也具有商业潜力，包括输液溶液（血浆扩张液、补液、营养液和电解质溶液）和灌溉溶液。该项目可能有助于在灾害情况下、物资短缺期间和冲突地区迅速产生重要的医疗解决方案。该技术还可以帮助支持大批量非注射解决方案的供应链，并防止因供应链干扰而导致的短缺。这个I-Corps项目开发了一种生物制药设备，用于按需或在护理点快速生产大量的肠外溶液。该装置的工作原理是：产生注射用水，将注射用水与溶质浓缩物结合，形成所要的非注射溶液，并将该溶液装袋。该设备可以在符合现有复合无菌制剂指南的工艺中以商业上相关的速率生成肠外溶液。与传统的复合工艺不同，无菌性不需要使用洁净室，允许生产在护理点附近进行。该技术分散了生产和供应，允许在低资源环境下进行静脉注射溶液制造。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/commercial potential of this I-Corps project is improved accessibility to dialysis solutions in low resource settings through local, decentralized dialysis fluid production. Due, in part, to lack of local production of dialysis fluids in some countries, limited access to dialysis fluid results in millions of deaths globally. Importation of dialysis solution can lead to high costs that can often make the vital solutions unaffordable to kidney failure patients. The proposed technology has the potential to help reduce costs and increase access for more patients, while also improving profitability for providers. Beyond global kidney care, the technology has commercial potential in other essential, large volume parenteral solutions, including infusion solutions (plasma expanders, rehydration fluids, nutritional and electrolyte solutions) and irrigation solutions. This project may help in the rapid generation of vital medical solutions in disaster situations, during shortages, and in conflict zones. The technology may also help support the supply chains for large volume parenteral solutions and prevent the shortages that can result from supply chain disturbances.This I-Corps project develops a biopharmaceutical device for rapidly producing large volumes of parenteral solutions on-demand or at the point of care. The device works by generating water for injection, combining water for injection with solute concentrates to form the parenteral solution of interest, and bagging the solution. The device can generate parenteral solutions at commercially relevant rates in a process consistent with existing guidelines for compounded sterile preparations. Unlike traditional compounding processes, sterility is ensured without the use of a clean room, allowing production to take place near the point of care. This technology decentralizes production and supply, allowing parenteral solution manufacturing to be available for low resource settings.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.