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

这个i-Corps项目的更广泛的影响/商业潜力是通过当地分散的透析液生产，在低资源环境下改善获得透析解决方案的机会。在一定程度上，由于一些国家缺乏当地生产的透析液，有限的透析液获取导致全球数百万人死亡。进口透析液可能会导致高昂的成本，这往往会使肾衰竭患者负担不起至关重要的解决方案。这项拟议的技术有可能帮助降低成本，增加更多患者的机会，同时还可以提高提供商的盈利能力。除了全球肾脏护理，该技术在其他基本的大容量肠外解决方案方面也具有商业潜力，包括输液解决方案(血浆扩张器、再水化液体、营养和电解质解决方案)和灌流解决方案。该项目可能有助于在灾害情况下、在短缺期间和在冲突地区快速制定重要的医疗解决方案。这项技术还可能有助于支持大容量非肠外解决方案的供应链，并防止供应链中断可能导致的短缺。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非肠外解决方案。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感兴趣的注射外溶液，并将溶液装袋。该设备可以在与现有的复合无菌制剂指南一致的过程中，以商业上相关的速度产生非肠道解决方案。与传统的复合工艺不同，无需使用洁净室即可确保无菌，从而使生产可以在护理地点附近进行。这项技术分散了生产和供应，使非肠道解决方案制造可以在低资源环境下使用。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.