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) intends to acquire a Thermo Scientific Orbitrap Excedion Pro BioPharma Mass Spectrometer and UHPLC system or an "equal" product. This high-resolution mass spectrometry system with ultra-high-performance liquid chromatography capability will support the analysis of pharmaceutical drug substances and products, including the detection and characterization of nitrosamine impurities, small molecules, peptides, and other biomolecules at their St. Louis facility. This acquisition is conducted on a brand-name-or-equal basis.
Scope of Work
The Government requires an integrated LC-MS analytical system for regulatory-grade analytical workflows, pharmaceutical quality evaluation, and impurity characterization. Key requirements include:
- High-resolution accurate-mass (HRAM) mass spectrometry capable of resolving complex mixtures and trace-level impurities.
- Extended mass range (up to m/z 12,000) for small molecules and 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) and centralized data management (e.g., Ardia Platform).
- Delivery, installation, and instrument qualification (IQ/OQ) services.
- Vendor-provided familiarization and operational training.
- Minimum one-year manufacturer warranty covering parts, labor, travel, and OEM-certified service.
Contract & Timeline
- Type: Combined Synopsis/Solicitation, Firm-Fixed-Price (FFP).
- Set-Aside: Total Small Business.
- NAICS Code: 334516 (Analytical Laboratory Instrument Manufacturing), Size Standard: 1,000 Employees.
- Place of Performance: Saint Louis, MO.
- Delivery: Within 90 days of award.
- Installation & Qualification: Within 90 days of delivery.
- Proposals Due: May 6, 2026, 4:00 PM ET.
- Questions Due: May 6, 2026, 12:00 PM ET.
- Published: May 1, 2026.
- Offer Acceptance Period: 90 calendar days.
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 all identified salient characteristics. Submissions must include a technical quotation, price quotation, warranty terms, 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 via the U.S. Department of Treasury's Invoice Processing Platform (IPP). Offerors are responsible for monitoring SAM.gov for any amendments.