Biorelevant Characterization System for Subcutaneous Injections Tender, USA - 118363036

Procurement Summary

Country : USA

Summary : Biorelevant Characterization System for Subcutaneous Injections

Deadline : 09 May 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 118363036

Document Ref. No. :

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

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.

Documents

 Tender Notice