SAM #75F40126Q00088

FDA Procurement of Orbitrap Excedion Pro BioPharma Mass Spectrometer and UHPLC System

The FDA's Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Pharmaceutical Quality Research (OPQR) in St. Louis is procuring a high-resolution mass spectrometry system with integrated UHPLC capability to support pharmaceutical quality analysis and impurity detection. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - CDER/OPQ/OPQR, St. Louis - OEMs and Vendors: - Thermo Scientific (OEM) - Equivalent products from other OEMs are permitted if they meet all salient requirements - Products/Services Requested: - Orbitrap Excedion Pro BioPharma Mass Spectrometer and UHPLC System (or equal) - Part Number: BRE725570 - Includes Vanquish Horizon UHPLC System, Binary Pump, Autosampler, Column Compartment, Diode Array Detector with LightPipe technology - BioPharma Finder Software (Part Number: OPTON-31068) - Ardia Platform Setup (Part Number: CSW0062124) - Delivery, installation, instrument qualification (IQ/OQ), and system documentation - User familiarization and training for 2-3 scientists - Manufacturer warranty (minimum one year) - Optional annual preventive maintenance and OEM-certified service support (up to four years post-warranty) - Unique/Notable Requirements: - System must support regulatory-grade analytical workflows for pharmaceutical quality evaluation, including nitrosamine impurity detection, small molecule, peptide, and biomolecule characterization - High-resolution accurate-mass detection, extended mass range (up to m/z 12,000), trace-level sensitivity, biocompatible UHPLC integration - Advanced instrument control and data analysis software, automated data processing, centralized data management - Delivery, installation, IQ/OQ, training, and warranty required - Optional preventive maintenance service for up to four years after warranty - Place of Performance: - CDER/OPQ/OPQR St. Louis, 645 S. Newstead Ave., Saint Louis, MO 63110 - Contracting Office: - FDA Office of Acquisition and Grant Services, 11601 Landsdown St, Floor 13, Rockville, MD 20852

Description

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.

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