End to End, Cold Chain Validation Using Sample Attached History Log

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Abstract Regenerative medicine therapies of various kinds are promising and rapidly growing, both in scale and type. The therapeutic products are not pills–they are living cells that are harvested from a patient (or sometimes a cell bank) and are shipped to a pharmaceutical company that modifies the cells and then sends them back to be re- injected into the patient. Logistics plays an outsize role in this process because the samples need to be maintained at ultra-low temperatures throughout the shipping process. Because these samples are personalized to a particular patient, they are not replaceable with something else. If damaged or switched, the outcome will be dire. The state-of-the-art shipment technology today is, a dry shipper at liquid nitrogen temperature with a temperature logger that is physically attached to the dry shipper–but they report the temperature of the shipper, not the sample so if a sample is removed for inspection, this will not be recorded. For regenerative medicine therapies to be successful, it is essential that the end-to-end processes of freezing, storage, and thawing are carried out in strict adherence to precisely defined protocols. Transient warming events and variability in product temperatures throughout shipping and distribution can negatively affect the samples and contribute to poor clinical outcomes. Therefore, it is necessary to validate optimized cold chain practices individually for each sample, to ensure the highest quality therapeutic outcomes. The goal of this fast-track proposal is to develop a functional pilot product that will provide an on-the-sample, end to end temperature log before, during, and after shipping. Software will compare user-defined protocol criteria with the sample temperature record and will provide a go / no-go decision for use of the sample. The specific aims of the project are: (a) develop the on-sample electronics that records the temperature history of the sample along with timestamps with an accuracy of 2 °C, (b) develop the shipper electronics that needs to operate for 3 days on batteries and record time stamped sample temperatures and transmits that data back to the sample custodian, and (c) develop a cryogenic container that can keep the sample data acquisition active while the samples moving around in the lab, and finally (d) a quality assurance station the can inform the end user if the sample is viable by checking the sample's temperature record against the criteria set by the protocols for that sample.