Biorelevant characterization system for subcutaneous injections

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The FDA Office of Acquisitions and Grants Services (OAGS), on behalf of Center for Drug Evaluation and Research (CDER), seeks vendors who can provide a Biorelevant Characterization System and a domestic product offering. Responses from both small and large businesses are welcome.

If your firm is a small business under NAICS Code 334516 (Analytical Laboratory Instrument Manufacturing) with 1,000 employees or fewer and can provide the required supplies/services, please email Erika.Crawford@fda.hhs.gov and maria.finan@fda.hhs.gov.

Background: FDA/CDER needs a Biorelevant Characterization System with 4 one-year post-warranty maintenance options. The system is 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 Office of Pharmaceutical Quality (OPQ)/ the Office of Pharmaceutical Quality Research (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.