# Biorelevant characterization system for subcutaneous injections

Canonical: https://abierto.us/opportunities/75f401f25r00066

- Solicitation number: 75F401F25R00066
- Notice type: Combined synopsis and solicitation
- Status: Closed. Deadline was May 9, 2025 at 12:00 PM EDT
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: FDA Office of Acq Grant SVCS (75F401)
- NAICS: 334516 Analytical Laboratory Instrument Manufacturing
- Product or service code: 6640 Laboratory Equipment and Supplies
- Set-aside: Total small business set-aside
- Place of performance: Saint Louis, Missouri
- County: City of St. Louis (FIPS 29510). https://abierto.us/counties/city-of-st-louis-mo-29510
- City: St. Louis. https://abierto.us/cities/st-louis-mo-2965000
- First posted: April 28, 2025
- Last posted: April 29, 2025
- SAM.gov: https://sam.gov/workspace/contract/opp/e7b5da43dd2742e09bcb512920bf6ff1/view

## 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.

## Publications

- April 28, 2025: Combined synopsis and solicitation, due May 9, 2025 at 12:00 PM EDT. Notice c618aeb4b6164dfcaa48754b26990d13. https://sam.gov/workspace/contract/opp/c618aeb4b6164dfcaa48754b26990d13/view
- April 29, 2025: Combined synopsis and solicitation, due May 9, 2025 at 12:00 PM EDT. Notice 79f0c6d6d37d4d8c94041c4399534554. https://sam.gov/workspace/contract/opp/79f0c6d6d37d4d8c94041c4399534554/view
- April 29, 2025: Combined synopsis and solicitation, due May 9, 2025 at 12:00 PM EDT. Notice e7b5da43dd2742e09bcb512920bf6ff1. https://sam.gov/workspace/contract/opp/e7b5da43dd2742e09bcb512920bf6ff1/view

## Points of contact

- Erika Crawford, erika.crawford@fda.hhs.gov, 3017960298

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/75f401f25r00066.