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

Award Number: R44OD033638
ORGANIZATION: OFFICE OF THE DIRECTOR, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 12/31/2024

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $1,091,042 )
2024	2024	BIOTILLION LLC	148 TAMARACK CIR	SKILLMAN	NJ	08558	SOMERSET	USA	Research Infrastructure Programs	001	3	5/14/2024	NON-COMPETING CONTINUATION	$0
2024	2024	BIOTILLION LLC	148 TAMARACK CIR	SKILLMAN	NJ	08558	SOMERSET	USA	Research Infrastructure Programs	000	3	12/20/2023	NON-COMPETING CONTINUATION	$1,091,042
														Subtotal = $1,091,042

Issue Date FY: 2023 ( Subtotal = $1,079,406 )
2023	2023	BIOTILLION LLC	148 TAMARACK CIR	SKILLMAN	NJ	08558	SOMERSET	USA	Research Infrastructure Programs	000	2	12/28/2022	EXTENSION WITH OR WITHOUT FUNDS	$1,079,406
														Subtotal = $1,079,406

Issue Date FY: 2022 ( Subtotal = $226,448 )
2022	2022	BIOTILLION, LLC	148 TAMARACK CIRCLE	SKILLMAN	NJ	08558	SOMERSET	USA	Research Infrastructure Programs	000	1	8/22/2022	NEW	$226,448
														Subtotal = $226,448

Grand Total All Awards = $2,396,896

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

Award Number: R44OD033638

ORGANIZATION: OFFICE OF THE DIRECTOR, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 12/31/2024

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