Biorelevant characterization system for subcutaneous injections
SAM.GOV Due: May 9, 2025 at 04:00 PM UTC
In-Active Combined Synopsis/Solicitation SBA Source Url

Summary

The opportunity involves the procurement and installation of a biorelevant characterization system specifically designed for subcutaneous injections. This system will be utilized at the FDA's Center for Drug Evaluation and Research (CDER) to enhance the evaluation of pharmaceutical products' quality, safety, and efficacy. The system will simulate physiological conditions to assess the release performance of various subcutaneous formulations, including biologics and small molecules. Contractors with expertise in biomedical instrumentation, particularly those capable of providing advanced in vitro systems with integrated monitoring capabilities, are encouraged to bid on this project. The work will require not only the provision of the system but also installation, qualification, and training services.
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

Entities
HAHSDO
Department of Health and Human Services
FADA
Food and Drug Administration
NAICS
334516
Set Aside
SBA : Total Small Business Set-Aside (FAR 19.5)
Place of Performance
Saint Louis , Missouri 63110
Point of Contact
Full Name Email Phone Type
Erika Crawford [email protected] 3017960298 primary
Attachments
  • Attachment+SOW.pdf
  • Attachment+A+Pricing+Sheet+.xlsx
  • 75F40125R00066+Combined+Synopsis+Solicitation.pdf