Rapid pre-release sterility test for pet drugs
Ended Project Grant Awarded Last action
- Award ID
- R43FD006914
- Recipient
-
Trace-Ability Inc. UEI S11KA2DGF4J6
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $427,729
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date
- Originally
- Funding
-
- $259,642.35 Federal
- $168,087.00 Non-federal
- Funding agency
- Office of the Commissioner Food and Drug Administration, Department of Health and Human Services
- Place of performance
- California, USA
Award details come from USAspending.gov.
Description
- Abstract
- Traditional process of sterility testing requires a 14-day sample incubation in different media. That makes IT impossible to establish a pre-release sterility testing for pet tracers, which have half-lives of 9 to 110 minutes and must be released within 1 hour after synthesis. Moreover, even with numerous controls in place, in the past two years two of three of the largest US pet tracer manufacturers have been issued sterility warnings from the FDA. Trace-ability proposes a novel approach to rapid sterility testing without incubation, with sterility results available within 1 hour. The solution will take advantage of microfluidic chip technology and will be completely automated and incorporated into the only commercially available and validated automated pet tracer QC platform. Proposed rapid sterility test involves assessing viability by probing whether cellular membranes are intact, and whether there is DNA in those membranes. This will be achieved by selective fluorescent staining of up to 250 ΜL of sample on a microfluidic chip. To check cell viability, we will take advantage of two stains. The difference of the two signals will indicate whether the organism may be able to reproduce. Proposed solution is intended to enable automated sterility testing and include IT into pre-release automated QC workflows for the 1ST time in history of pet. Specific aim 1: selection of fluorescent stains that can provide the high selectivity and differentiability of viable cells. A combination of stains will be selected that can differentiate between viable and non-viable organisms for 10 typical bacterial species. Evaluation criteria: (1) viability stains incorporate within 30 minutes, (2) organisms retain viability after staining, (3) stains for nonviable organisms have twice the binding affinity of the viability stains, being able to displace any free DNA. (4) bound:unbound ratio > 1000. (5) limits of detection down to 10 CFU (colony-forming unit). Specific aim 2: development of microfluidic analysis chip for signal to noise (s/n) ratio optimization. Taking the optimal stains established in aim 1, these will then be mixed with bacteria in low concentration and loaded onto microfluidic chips with varying channel sizes and shapes while monitoring fluorescence emission for background reduction and s/n increase. Evaluation criteria: (1) a limit of detection (LOD) of 1 CFU, (2) a 100-fold improvement in s/n, (3) filling times less than 30 minutes for 250 ΜL. Once feasibility is verified in phase 1, this work has a clear path to commercialization by implementing the test into the tracer-QC platform. This will allow pet manufactures to have a complete QC package in a single automated system that meets all compliance criteria. This work can extend well beyond pet to compounding pharmacies and other small-scale manufacturers, offering simplification of the experimental setup, procedural changes in production, and regulatory changes to improve patient safety.
Transactions
| Action | Federal | Non-federal | Date |
|---|---|---|---|
| Amendment | $0 | $0 | |
| Amendment | -$76,532 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $168,087 | $0 | |
| Original award | $168,087 | $168,087 |
Quick answers
Who received award R43FD006914?
R43FD006914 was awarded to Trace-Ability Inc. by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 20, 2021.
How much is award R43FD006914 worth?
$427,729 has been obligated on R43FD006914: $259,642 in federal funding and $168,087 in non-federal funding.
Which agency awarded R43FD006914?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded R43FD006914, with funding from Office of the Commissioner (Food and Drug Administration).
On GovTribe
See this award's full record
- Every transaction and subaward
- The recipient's other awards and teaming partners
- Similar grant awards
- Ask GovTribe AI about this award