An Integrated Oxygen‐Supplying Device and Predictive Multiphysics Model for Extended Ambient Transport of Insulin‐Producing Cells

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ABSTRACT Cell therapies are a transformative pillar in healthcare, offering treatments for a diverse range of rare and chronic diseases. However, their complex supply chain relies on cryopreservation and cold‐chain logistics, which limits access to these life‐saving treatments, and the freeze–thaw process can affect their therapeutic quality. Here, we present an ambient temperature transportation system consisting of a novel dual chamber device that facilitates shipment of fresh cells by providing sustained oxygen delivery and extracellular matrix support, eliminating the need for cryopreservation. This device was optimized to maximize oxygen‐carrying capacity for over 70 h at baseline. In parallel, a finite element model was developed to capture oxygen transfer within the device and cellular oxygen consumption. Focusing on insulin‐producing cells as a representative cargo given their oxygen sensitivity, the computational framework predicts the optimal cell density for a 48‐h international pilot ambient shipment based on oxygen durability, or the time taken for the system to reach atmospheric oxygen levels. Post‐shipment, the cells remained viable and functional, outperforming their cryopreserved controls. This tunable platform can be adapted to suit a range of biological cargoes, improving their quality and extending ambient shipment timeframes while reducing economic and environmental costs associated with cold‐chain logistics.

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