Orbitrap Excedion Pro BioPharma Mass Spectrometer and UHPLC
Closed Solicitation Posted
- Solicitation number
- 75F40126Q00088
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Saint Louis, Missouri 63110, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The FDA's Office of Acquisition and Grant Services seeks to procure one Thermo Scientific Orbitrap Excedion Pro BioPharma Mass Spectrometer and ultra-high-performance liquid chromatography system on a brand-name-or-equal basis, with questions due May 6, 2026 at 12:00 PM and proposals due May 7, 2026. This is not a small business set-aside, though the NAICS small business size standard is 1,000 employees.
Place of performance is St. Louis, Missouri (CDER/OPQ/OPQR, 645 S. Newstead Ave.). The system must support regulatory-grade analytical workflows for pharmaceutical quality evaluation and impurity characterization, including detection and characterization of nitrosamine impurities, small molecules, peptides, and other biomolecules. Salient characteristics include high-resolution accurate-mass detection, resolving power sufficient for molecular identification and impurity characterization, extended mass range capability to approximately m/z 12,000, sensitivity for trace-level pharmaceutical impurity detection, compatibility with an integrated UHPLC system suitable for biocompatible applications, and integrated instrument control and data analysis software. Products offered as equals must meet or exceed these characteristics to be considered technically acceptable.
Delivery must occur within 90 days of award, with installation, instrument qualification (IQ/OQ), software configuration, and training completed within 90 days of delivery. The contract will be Firm-Fixed-Price under FAR Parts 12 and 13 for commercial products, covering a base period of delivery, installation, training, and a minimum one-year manufacturer warranty, with optional periods for preventive maintenance and OEM-certified service support available for up to four additional 12-month periods. Award will be made using Lowest Price Technically Acceptable evaluation. Vendors must submit technical compliance matrices for equal products, price quotations, warranty terms, UEI/SAM.gov registration confirmation, lead time, and country of origin information. Invoices must be submitted electronically through the FDA's Invoice Processing Platform.
Notice text
The Government intends to acquire a high-resolution mass spectrometry system with ultra-high-performance liquid chromatography capability to support the analysis of pharmaceutical drug substances and drug products, including detection and characterization of nitrosamine impurities, small molecules, peptides, and other biomolecules. The Thermo Scientific Orbitrap Excedion Pro BioPharma MS and UHPLC system is referenced as the brand-name product used to define the level of performance and functionality required.
This acquisition is conducted on a brand-name-or-equal basis. Products offered as an “equal” must meet or exceed the salient characteristics identified below in order to be considered technically acceptable.
The Government requires an integrated LC-MS analytical system capable of supporting regulatory-grade analytical workflows for pharmaceutical quality evaluation and impurity characterization. The system must provide high-resolution, accurate-mass detection across a wide mass range to support both small molecule and biomolecule applications, including trace-level impurity detection and characterization of peptide-based therapeutics.
At a minimum, the offered system shall meet the following salient characteristics:
• High-resolution accurate-mass (HRAM) mass spectrometry system capable of resolving complex mixtures and trace-level impurities in pharmaceutical samples
• Mass analyzer capable of achieving resolving power sufficient for high-confidence molecular identification and impurity characterization
• Extended mass range capability to analyze both small molecules and larger biomolecules (minimum mass range approximately up to m/z 12,000)
• Sensitivity sufficient for trace-level detection of pharmaceutical impurities, including nitrosamines
• Compatibility with an integrated ultra-high-performance liquid chromatography (UHPLC) system suitable for biocompatible analytical applications
• Integrated instrument control and data analysis software capable of supporting advanced analytical workflows for small molecule and peptide characterization
• Capability for automated data processing, spectral deconvolution, and identification workflows for complex pharmaceutical samples
• Centralized data management capability supporting secure instrument operation, workflow automation, and laboratory data integration
• Delivery, installation, and instrument qualification (IQ/OQ) services for the complete LC-MS system
• Vendor-provided instrument familiarization and operational training
• Minimum one (1) year manufacturer warranty covering parts, labor, travel, and OEM-certified service support, beginning upon Government acceptance of the system
The Government will evaluate quotations offering the referenced brand-name product or equal products that meet the above salient characteristics. Offerors proposing an equal product must clearly demonstrate in their quotation how the proposed equipment meets or exceeds each of the required salient characteristics.
Files
| File | Type | Posted |
|---|---|---|
| Combined_Syn.docx | DOCX document |
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