Biorelevant characterization system for subcutaneous injections Tender, USA - 117369335

Procurement Summary

Country : USA

Summary : Biorelevant characterization system for subcutaneous injections

Deadline : 18 Apr 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 117369335

Document Ref. No. : SSN_CDER-2025-126738

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

THIS IS A SOURCES SOUGHT NOTICE FOR MARKET RESEARCH PURPOSES ONLY. IT IS NOT A SOLICITATION FOR PROPOSALS, AND NO CONTRACT WILL BE AWARDED. THE FDA WILL NOT REIMBURSE COSTS ASSOCIATED WITH RESPONDING. TELEPHONE INQUIRIES WILL NOT BE ACCEPTED, AS THERE IS NO RFQ OR SOLICITATION. TO MAINTAIN PROCUREMENT INTEGRITY, NO TECHNICAL CONTACT INFORMATION OR PRESENTATION APPOINTMENTS WILL BE PROVIDED.

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.
Active Contract Opportunity
Notice ID : SSN_CDER-2025-126738
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: Sources Sought (Original)
Original Published Date: Apr 07, 2025 12:50 pm EDT
Original Response Date: Apr 18, 2025 12:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: May 03, 2025
Initiative: None

Classification
Original Set Aside:
Product Service Code: 6640 - LABORATORY EQUIPMENT AND SUPPLIES
NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing

Place of Performance: Saint Louis, MO 63110 USA

Documents

 Tender Notice

SSN_CDER-2025-126738_FINAL.pdf