SBIR-STTR Award

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 cellbank) and are shipped to a pharmaceutical company that modi?es 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 bemaintained at ultra-low temperatures throughout the shipping process. Because these samples are personalizedto a particular patient, they are not replaceable with something else. If damaged or switched, the outcome willbe dire.The state-of-the-art shipment technology today is, a dry shipper at liquid nitrogen temperature with atemperature 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 eventsand variability in product temperatures throughout shipping and distribution can negatively affect the samplesand contribute to poor clinical outcomes. Therefore, it is necessary to validate optimized cold chain practicesindividually 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 protocolcriteria 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 historyof the sample along with timestamps with an accuracy of 2 °C, (b) develop the shipper electronics that needs tooperate for 3 days on batteries and record time stamped sample temperatures and transmits that data back to thesample custodian, and (c) develop a cryogenic container that can keep the sample data acquisition active whilethe samples moving around in the lab, and finally (d) a quality assurance station the can inform the end user ifthe sample is viable by checking the sample's temperature record against the criteria set by the protocols for thatsample.

Public Health Relevance Statement:
Narrative Regenerative medicine is a rapidly developing and promising field of modern medicine. Cells are removed from a patient, then shipped at ultra-cold temperatures to a pharmaceutical company for modification, shipped back and then put back into the patient. We are developing a technology that provides a cold-chain of custody for each sample so that the end user can make an informed decision about the sample's viability.

Project Terms:

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 cellbank) 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 bemaintained at ultra-low temperatures throughout the shipping process. Because these samples are personalizedto a particular patient, they are not replaceable with something else. If damaged or switched, the outcome willbe dire.The state-of-the-art shipment technology today is, a dry shipper at liquid nitrogen temperature with atemperature 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 eventsand variability in product temperatures throughout shipping and distribution can negatively affect the samplesand contribute to poor clinical outcomes. Therefore, it is necessary to validate optimized cold chain practicesindividually 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 protocolcriteria 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 historyof the sample along with timestamps with an accuracy of 2 °C, (b) develop the shipper electronics that needs tooperate for 3 days on batteries and record time stamped sample temperatures and transmits that data back to thesample custodian, and (c) develop a cryogenic container that can keep the sample data acquisition active whilethe samples moving around in the lab, and finally (d) a quality assurance station the can inform the end user ifthe sample is viable by checking the sample's temperature record against the criteria set by the protocols for thatsample.

Public Health Relevance Statement:
Narrative Regenerative medicine is a rapidly developing and promising field of modern medicine. Cells are removed from a patient, then shipped at ultra-cold temperatures to a pharmaceutical company for modification, shipped back and then put back into the patient. We are developing a technology that provides a cold-chain of custody for each sample so that the end user can make an informed decision about the sample's viability.

Project Terms: