Biorelevant Characterization System for Subcutaneous Injections

Provide a Biorelevant Characterization System and a domestic product offering. 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.