SSN_CDER-2025-131687.docx

SOURCES SOUGHT NOTICE

TITLE: Mass Spectrometer Notice Number: SSN_CDER-2026-131687 THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING A RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), on behalf of CDER/OPQ/OPQR, is issuing this Sources Sought Notice to:

a) identify vendors capable of providing the equipment and service as detailed in this notice, and

b) vendors capable of providing a domestic product offering. Responses from small and other than small businesses are appreciated and accepted.

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing Small Business Size Standard: Small Business

BACKGROUND

The Office of Pharmaceutical Quality Research – St. Louis (OPQR – St. Louis) has been providing laboratory testing and research support and has supported the Office of Pharmaceutical Quality (OPQ) Nitrosamine Taskforce since the emergence of the nitrosamine contamination issue in early 2018.

Over time, the scope of this issue has expanded from initial contamination (i.e. NDMA, NDEA, etc.) in angiotensin receptor blocker (ARB) drug products to include nitroso drug substance-related impurities (NDSRIs) and fragment NDSRIs in both prescription and over the counter (OTC) drug products.

To support this ongoing work, OPQR – St. Louis requires a high-resolution, accurate mass spectrometer system with advanced fragmentation capabilities to support analysis of nitrosamine impurities, small molecules, and macro biomolecules.

OBJECTIVE

The Government is seeking to acquire one high-resolution mass spectrometer system with Ultra-High-Performance Liquid Chromatography (UHPLC) capabilities to enhance CDER/OPQ/OPQR – St. Louis’ ability to characterize drug substances and drug products with potential nitrosamine impurities, small molecules, and macromolecules in support of domestic drug manufacturing.

The Thermo Scientific Orbitrap Excedion Pro BioPharma MS system is referenced to describe the required performance capabilities. Systems of equal capability that meet all required characteristics will be considered.

SALIENT CHARACTERISTICS

· Extended mass range up to m/z 12,000 for large biomolecule analysis

· Fast and sensitive electron-based fragmentation (ETD/EThcD) for comprehensive structural characterization

· Enhanced Sensitivity and dynamic range with eDR scan mode

· Superior fragmentation capabilities for complex molecule identification The excellent sensitivity, resolution, and advanced fragmentation capabilities of this mass spectrometer will be used to identify nitrosamine drug substance related impurities (NDSRIs) by matching accurate mass measurements with calculated monoisotopic masses, and to develop fit-for-purpose methods to accurately detect and quantitate NDSRIs. Additionally, the system will support comprehensive biotherapeutic characterization, including peptide mapping, intact mass analysis, and post-translational modification studies.

This work requires a high-resolution, accurate mass spectrometer with advanced fragmentation capabilities like the Orbitrap Excedion Pro Mass Spectrometer. The system will integrate with the Ardia Platform for centralized data management and utilize BioPharma Finder software for comprehensive data analysis workflows.

SCOPE OF REQUIREMENT

This requirement includes delivery, installation, qualification, and instrument familiarization for one new mass spectrometer system with UHPLC.

The contractor shall demonstrate proper operation and performance of the instrument upon installation and completion of qualification activities.

DELIVERABLES

· Contract period: 12 months from award

· Optional service agreement: 1-year annual preventive maintenance following warranty

· Total Period of Performance: 2 years Schedule:

· Delivery: Within 180 days after award

· Installation & Qualification: Within 90 days after delivery

· Training & Familiarization: During qualification or within 60 days after installation

· Warranty Start: Upon completion of IQ/OQ completion

REQUESTED INFORMATION FROM VENDORS

Interested vendors shall provide the following information:

· Company's name, mailing address, Cage Code, and Unique Entity Identifier (UEI).

· Recommended North American Industry Classification System (NAICS) code that your company utilizes for in support of the following equipment: Mass Spectrometer.

· What is your company size? If small, what is your socio-economic status?

· Identify any GSA Schedule contract or other current government-wide contract (e.g., GWAC or BPA) that your company currently holds and offers these products/services under.

· Domestic manufacturing status.

· Technical specifications for the proposed solution.

DISCLAIMER AND IMPORTANT NOTES

This notice is issued for market research purposes only and does not constitute a solicitation. Responses will be used solely for market research. The FDA will not provide feedback or evaluations of submitted capabilities. Proprietary information should not be submitted.

SUBMISSION INSTRUCTIONS

Responses are due by March 6, 2026, and shall be submitted via email to:

Reagan Davis Contract Specialist Email: Reagan.davis@fda.hhs.gov Subject: Sources Sought Notice Number: SSN_CDER-2026-131687

– Mass Spectrometer