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

University Of Minnesota-Twin Cities, Minneapolis MN

Investigators

Abstract

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.