End to end, cold chain validation using sample attached history log

Ended Project Grant Awarded Last action

Award ID
R44OD033638
Recipient
Awarding agency
Obligated
$6,952,604

Award facts

Assistance listing
93.351 Research Infrastructure Programs
Completion date
Originally
Funding agency
Office of the Director National Institutes of Health, Department of Health and Human Services
Place of performance
New Jersey, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

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 modies 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 dened 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-dened protocol criteria with the sample temperature record and will provide a go / no-go decision for use of the sample. The specic 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 nally (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.

Transactions

Action Obligated Date
Amendment $0
Amendment $0
Amendment $1,091,042
Amendment $1,091,042
Amendment $1,079,406
Amendment $1,079,406
Amendment $1,079,406
Amendment $1,079,406
Amendment $226,448
Original award $226,448

Quick answers

Who received award R44OD033638?

R44OD033638 was awarded to Biotillion LLC by Aggregate Financial Assistance Data (National Institutes of Health) on September 1, 2022.

How much is award R44OD033638 worth?

$6,952,604 has been obligated on R44OD033638.

Which agency awarded R44OD033638?

Aggregate Financial Assistance Data (National Institutes of Health) awarded R44OD033638, with funding from Office of the Director (National Institutes of Health).

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