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HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION has floated a tender for Biorelevant characterization system for subcutaneous injections. The project location is USA and the tender is closing on 09 May 2025. The tender notice number is 75F401F25R00066, while the TOT Ref Number is 118368234. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country : USA
Summary : Biorelevant characterization system for subcutaneous injections
Deadline : 09 May 2025
Other Information
Notice Type : Tender
TOT Ref.No.: 118368234
Document Ref. No. : 75F401F25R00066
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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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.
Active Contract Opportunity
Notice ID : 75F401F25R00066
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION
Office: FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
Original Published Date: Apr 28, 2025 05:39 pm EDT
Original Date Offers Due: May 09, 2025 12:00 pm EDT
Inactive Policy: 15 days after date offers due
Original Inactive Date: May 24, 2025
Initiative: None
Classification
Original Set Aside: Total Small Business Set-Aside (FAR 19.5)
Product Service Code: 6640 - LABORATORY EQUIPMENT AND SUPPLIES
NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing
Place of Performance: Saint Louis, MO 63110 USA
Documents
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