Orbitrap Excedion Pro BioPharma Mass Spectrometer and UHPLC
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), under the Department of Health and Human Services, intends to acquire a Thermo Scientific Orbitrap Excedion Pro BioPharma Mass Spectrometer and UHPLC system or an equal product. This system will support the analysis of pharmaceutical drug substances and products, including the detection and characterization of nitrosamine impurities, small molecules, peptides, and other biomolecules, to enhance the capabilities of CDER/OPQ/OPQR – St. Louis. This acquisition is a Total Small Business Set-Aside. Quotations are due by May 7, 2026, at 4:00 PM ET.
Scope of Work
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 for both small molecule and biomolecule applications, including trace-level impurity detection and characterization of peptide-based therapeutics.
Key salient characteristics include:
- High-resolution accurate-mass (HRAM) mass spectrometry for complex mixtures and trace impurities.
- Extended mass range up to m/z 12,000 for small and large biomolecules.
- Sensitivity for trace-level detection of pharmaceutical impurities, including nitrosamines.
- Compatibility with an integrated ultra-high-performance liquid chromatography (UHPLC) system for biocompatible applications.
- Integrated instrument control and data analysis software (e.g., BioPharma Finder 5.3) with automated processing, spectral deconvolution, and identification workflows.
- Centralized data management capability (e.g., Ardia Platform integration).
- Delivery, installation, and instrument qualification (IQ/OQ) services.
- Vendor-provided instrument familiarization and operational training.
- Minimum one (1) year manufacturer warranty covering parts, labor, travel, and OEM-certified service support.
Contract & Timeline
- Contract Type: Firm-Fixed-Price (FFP).
- Period of Performance: Base period covers delivery, installation, training, and a one-year warranty. Option periods for preventive maintenance are available.
- Delivery: Within 90 days of award.
- Installation & Qualification: Within 90 days of delivery.
- Response Due: May 7, 2026, 4:00 PM ET.
- Questions Due: May 6, 2026, 12:00 PM ET.
- Offer Acceptance Period: 90 calendar days.
- Published Date: May 6, 2026.
Submission & Evaluation
Award will be made on a Lowest Price Technically Acceptable (LPTA) basis. Offerors proposing an "equal" product must clearly demonstrate how their proposed equipment meets or exceeds each required salient characteristic. Submissions must include a technical quotation, price quotation, warranty terms, Unique Entity Identifier (UEI), SAM.gov registration confirmation, lead time, and country of origin.
Additional Notes
This acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements. All invoices must be submitted electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). Offerors are responsible for monitoring SAM.gov for any amendments.