SAM #CDER-2026-131687

FDA Procurement of High-Resolution Mass Spectrometer System with UHPLC

The U.S. Food and Drug Administration (FDA) is seeking to procure and install a high-resolution mass spectrometer system with Ultra-High-Performance Liquid Chromatography (UHPLC) capabilities for its Center for Drug Evaluation and Research (CDER) / Office of Pharmaceutical Quality Research (OPQR) in St. Louis. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) / Office of Pharmaceutical Quality (OPQ) / Office of Pharmaceutical Quality Research (OPQR) St. Louis - Office of Acquisitions and Grants Services (OAGS) - OEMs and Vendors: - Thermo Scientific (referenced as the benchmark system: Orbitrap Excedion Pro BioPharma MS) - No specific OEM mandated; responses from small and domestic manufacturers are encouraged - Products/Services Requested: - One high-resolution, accurate mass spectrometer system with advanced fragmentation capabilities, extended mass range (up to m/z 12,000), fast electron-based fragmentation (ETD/EThcD), enhanced sensitivity and dynamic range, and integration with Ardia Platform and BioPharma Finder software - System must include Ultra-High-Performance Liquid Chromatography (UHPLC) - Delivery, installation, qualification, and training services for the system - Unique or Notable Requirements: - System must match or exceed the performance of the Thermo Scientific Orbitrap Excedion Pro BioPharma MS - Must support analysis of nitrosamine impurities, small molecules, and macromolecules - Includes demonstration of proper operation and performance upon installation and qualification - Optional 1-year preventive maintenance service agreement following warranty - Delivery required within 180 days of award; installation and qualification within 90 days of delivery; training within 60 days of installation - Warranty begins after installation and qualification - Place of Performance: - Office of Pharmaceutical Quality Research (OPQR) St. Louis, Missouri

Description

Mass Spectrometer. See attachments:

1. Sources Sought Notice

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