70NANB23H209
Cooperative Agreement
Overview
Grant Description
Purpose: Infratrac believes that personalized medicine can be developed using point-of-care drug printing. During its Phase II project, Infratrac will build upon its Phase I research that demonstrated an integrated system, using non-destructive technology, that has the potential to enhance trust and safety for drugs printed in pharmacies. In Phase II, work will focus on creating enforceable quality parameters fast and easy enough to accommodate prescribed doses.
Activities to be performed: In Phase II, Infratrac will demonstrate how it will detect and control for safety and quality issues in point-of-care 3D drug printing. They plan to expand the scope of research and development to include additional drugs and doses, include more failure types, and perform detection and predication capability into a commercially-viable tool for process control.
Expected outcomes: Infratrac's technology aims to provide hospital pharmacies and other point-of-care facilities with a mechanism to protect patients by preventing the inadvertent administration of 3D printed doses containing either too much or too little of the prescribed medication.
Intended beneficiaries: Hospitals, pharmacies, the general public, especially children and seniors, those with allergies, and other patients requiring non-standard, complex, easily swallowed, or in-between dosing of medications.
Subrecipient activities: Recipient will use the following subcontractors:
1. Applied Pharmaceutics Lab at University of MD School of Pharmacy
2. FABRX - a company that prints 3D printed dosage forms.
Activities to be performed: In Phase II, Infratrac will demonstrate how it will detect and control for safety and quality issues in point-of-care 3D drug printing. They plan to expand the scope of research and development to include additional drugs and doses, include more failure types, and perform detection and predication capability into a commercially-viable tool for process control.
Expected outcomes: Infratrac's technology aims to provide hospital pharmacies and other point-of-care facilities with a mechanism to protect patients by preventing the inadvertent administration of 3D printed doses containing either too much or too little of the prescribed medication.
Intended beneficiaries: Hospitals, pharmacies, the general public, especially children and seniors, those with allergies, and other patients requiring non-standard, complex, easily swallowed, or in-between dosing of medications.
Subrecipient activities: Recipient will use the following subcontractors:
1. Applied Pharmaceutics Lab at University of MD School of Pharmacy
2. FABRX - a company that prints 3D printed dosage forms.
Awardee
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Silver Spring,
Maryland
20910-3658
United States
Geographic Scope
Single Zip Code
Related Opportunity
None
Infratrac was awarded
Cooperative Agreement 70NANB23H209
worth $400,000
from the National Institute of Standards and Technology in October 2023 with work to be completed primarily in Silver Spring Maryland United States.
The grant
has a duration of 2 years and
was awarded through assistance program 11.620 Science, Technology, Business and/or Education Outreach.
SBIR Details
Research Type
SBIR Phase II
Title
Analytical Quality Management for 3D-Printed Small Molecule Drugs
Abstract
The promise of personalized medicine can be realized in part via point-of-care 3D drug printing, but only if there are reliable quality measures available. Children and seniors may need custom or easy-to-swallow doses, a need now addressed only in a limited way by ad-hoc in-pharmacy compounding. Compliance-targeted enhancements such as flavor and shape choices are particularly important for children with chronic diseases. InfraTrac has shown feasibility for an integrated system, using non-destructive technology, that has the potential to enhance trust and safety for drugs printed in pharmacies. A miniature near-infrared spectrometer, coupled with appropriate chemometric modeling, will be deployed to enforce quality bounds on each drug print. Building on Phase I success in distinguishing high-dose from low-dose prints, this work aims to create enforceable quality parameters fast and easy enough to use for every dose. The modeling is designed to be spectrometer-independent and printer-independent, for maximal commercial viability. In contrast to existing spectral libraries, these models are specific to 3D printing, and, perhaps more importantly, create bounded ranges for permissible variation. A printed dose will be considered to remain in-bounds, for example, if its flavor varies or an allergen is removed, but not if the active ingredient is altered.
Topic Code
2
Solicitation Number
2023-NIST-SBIR-02
Status
(Ongoing)
Last Modified 9/26/23
Period of Performance
10/1/23
Start Date
9/30/25
End Date
Funding Split
$400.0K
Federal Obligation
$0.0
Non-Federal Obligation
$400.0K
Total Obligated
Activity Timeline
Additional Detail
Award ID FAIN
70NANB23H209
SAI Number
70NANB23H209_0
Award ID URI
EXE
Awardee Classifications
Small Business
Awarding Office
1333ND DEPT OF COMMERCE NIST
Funding Office
1333ND DEPT OF COMMERCE NIST
Awardee UEI
SYELB4K7LDE8
Awardee CAGE
551B9
Performance District
MD-08
Senators
Benjamin Cardin
Chris Van Hollen
Chris Van Hollen
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| Working Capital Fund, National Institute of Standards and Technology, Commerce (013-4650) | Other advancement of commerce | Grants, subsidies, and contributions (41.0) | $400,000 | 100% |
Modified: 9/26/23