Purchase of AB Sciex ZenoTOF 7600+ and 4500 QTrap liquid chromatographs-tandem mass... Tender

Procurement Summary

Country : USA

Summary : Purchase of AB Sciex ZenoTOF 7600+ and 4500 QTrap liquid chromatographs-tandem mass spectrometers (LC-MS/MS)

Deadline : 14 May 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 118809310

Document Ref. No. : FDA-SSN-1285260

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

Bioanalysis is the quantitative measurement of both small molecule drugs and large biomolecules in biological systems for the purpose of pharmacokinetics, toxicokinetics, bioequivalence, and/or pharmacodynamics studies. The Division of Applied Regulatory Science (DARS) executes a variety of internal and external studies including clinical and nonclinical pharmacokinetic-pharmacodynamic modeling, bioequivalence, drug metabolism and transport, in-vivo/in-vitro correlations, and drug-drug interaction studies bioanalytical analyses at both the clinical and pre-clinical levels.

To support these projects, DARS currently utilizes five liquid chromatograph-tandem mass spectrometers (LC-MS/MS) from AB Sciex. Often these projects are of high-visibility, and mission critical (Opioids drug interaction, In-vivo conversion of ranitidine to carcinogen, sunscreens dermal absorption, cannabinoids, etc.) for the FDA leading to stringent deadlines and necessity for high quality data. We are also seeing an increased workload of internal in vitro projects aimed at evaluating microphysiological systems as appropriate tools for regulatory submissions. We are also providing bioanalytical support for a cross-center collaboration between CDER and CTP. As the drug development space moves towards biologics and biosimilars, it is important for DARS to equipped with the latest instrumentation necessary to analyze those products. Our current high resolution mass spectrometer is over 12 years old. The technology is obsolete. We are looking to replace our outdated technology with the ZenoTOF 7600+ LC-MS/MS system from AB Sciex. With this instrument we look to expand our analytical repertoire into the biologics and biosimilar realm.

TECHNICAL REQUIREMENTS

ZenoTOF 7600+ Mass Spectrometer

• TwinSpray TurboV Source,

• compatible with both ESI or APCI probes for automated calibration and allowing flow rates from 5 to 3000 ul/min (ESI) and flow rates from 200 to 300...
Active Contract Opportunity
Notice ID : FDA-SSN-1285260
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: May 07, 2025 01:28 pm EDT
Original Response Date: May 14, 2025 03:00 am EDT
Inactive Policy: 15 days after response date
Original Inactive Date: May 29, 2025
Initiative: None

Classification
Original Set Aside:
Product Service Code: AJ12 - GENERAL SCIENCE AND TECHNOLOGY R&D SERVICES; GENERAL SCIENCE AND TECHNOLOGY; APPLIED RESEARCH
NAICS Code: 541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance: Silver Spring, MD USA

Documents

 Tender Notice

Source-Sought.pdf