- Country: USA
- Summary: Purchase of AB Sciex ZenoTOF 7600+ and 4500 QTrap liquid chromatographs-tandem mass spectrometers (LC-MS/MS)
- UST Ref No: 118809310
- Deadline: 14 May 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: FDA-SSN-1285260
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- Description:
- 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 The technology is obsolete. We are looking to replace our outdated technology with the ZenoTOF 7600+ LC-MS/MS system from AB Sciex.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... - Documents:
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CLICK HERE TO LOGINPurchase of AB Sciex ZenoTOF 7600+ and 4500 QTrap liquid chromatographs-tandem mass spectrometers (LC-MS/MS) - USA Tender
The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION, a Government sector organization in USA, has announced a new tender for Purchase of AB Sciex ZenoTOF 7600+ and 4500 QTrap liquid chromatographs-tandem mass spectrometers (LC-MS/MS). This tender is published on USARFP under UST Ref No: 118809310 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-05-14.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
