Biorelevant characterization system for subcutaneous injections
| Location: | Missouri |
|---|---|
| Posted: | Apr 28, 2025 |
| Due: | May 9, 2025 |
| Agency: | HEALTH AND HUMAN SERVICES, DEPARTMENT OF |
| Type of Government: | Federal |
| Category: |
|
| Solicitation No: | 75F401F25R00066 |
| Publication URL: | To access bid details, please log in. |
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- Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
- Original Published Date: Apr 28, 2025 05:39 pm EDT
- Original Date Offers Due: May 09, 2025 12:00 pm EDT
- Inactive Policy: 15 days after date offers due
- Original Inactive Date: May 24, 2025
-
Initiative:
- None
- Original Set Aside: Total Small Business Set-Aside (FAR 19.5)
- Product Service Code: 6640 - LABORATORY EQUIPMENT AND SUPPLIES
-
NAICS Code:
- 334516 - Analytical Laboratory Instrument Manufacturing
-
Place of Performance:
Saint Louis , MO 63110USA
The scope is to purchase and install an in vitro biorelevant characterization system for subcutaneous injections at the injection site in an artificial extracellular matrix (ECM) with integrated camera and turbidity sensors, inline fiber optic probes, pH monitors, and an automated sample fraction collector for unattended operation and media refill after sampling. The aim is to expand and augment the capacity and capability of CDER/OPQ/OPQR to ensure quality, safety and efficacy of pharmaceutical products. In particular, this in vitro system will offer the capability for investigating the release performance of subcutaneous formulations under simulated physiological conditions. It assesses the critical drug attributes, risk and performance of subcutaneously administered drugs including biologics, peptides and small molecules.
- 4041 Powder Mill Road 4th Floor
- Beltsville , MD 20705
- USA
- Erika Crawford
- erika.crawford@fda.hhs.gov
- Phone Number 3017960298
- Apr 28, 2025 05:39 pm EDTCombined Synopsis/Solicitation (Original)
Related Document
| Apr 29, 2025 | [Combined Synopsis/Solicitation (Updated)] Biorelevant characterization system for subcutaneous injections |
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