SOLICITATION NOTICE
66 -- Biorelevant characterization system for subcutaneous injections
- Notice Date
- 4/29/2025 5:50:59 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- 75F401F25R00066
- Response Due
- 5/9/2025 9:00:00 AM
- Archive Date
- 05/24/2025
- Point of Contact
- Erika Crawford, Phone: 3017960298
- E-Mail Address
-
erika.crawford@fda.hhs.gov
(erika.crawford@fda.hhs.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/79f0c6d6d37d4d8c94041c4399534554/view)
- Place of Performance
- Address: Saint Louis, MO 63110, USA
- Zip Code: 63110
- Country: USA
- Zip Code: 63110
- Record
- SN07425254-F 20250501/250429230056 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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