Procurement and Installation of Mass Spectrometer

Sources Sought Notice

This is a market survey to identify vendors capable of providing a high-resolution mass spectrometer system with Ultra-High-Performance Liquid Chromatography (UHPLC) capabilities. The U.S. Food and Drug Administration (FDA), on behalf of CDER/OPQ/OPQR, requires this equipment to analyze nitrosamine impurities, small molecules, and macro biomolecules in drug substances and drug products, supporting domestic drug manufacturing. This notice is for information gathering only and is not a solicitation for proposals.

• One high-resolution mass spectrometer system with UHPLC capabilities.

• The system should have advanced fragmentation capabilities, similar to the Thermo Scientific Orbitrap Excedion Pro BioPharma MS system.

• Specific capabilities include:

  • Extended mass range up to m/z 12,000 for large biomolecule analysis.
  • Fast and sensitive electron-based fragmentation (ETD/EThcD).
  • Enhanced sensitivity and dynamic range with eDR scan mode.
  • Superior fragmentation for complex molecule identification.

• The system will integrate with the Ardia Platform and utilize BioPharma Finder software.

• Requirement includes delivery, installation, qualification, and instrument familiarization.

• Contract period: 12 months from award.

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

• Total Period of Performance: 2 years.

• Delivery: Within 180 days after award.

• Installation & Qualification: Within 90 days after delivery.

• Warranty Start: Upon completion of IQ/OQ.

Interested vendors must provide:

• Company name, address, Cage Code, and UEI.

• Recommended NAICS code (specifically for Mass Spectrometers).

• Company size and socio-economic status (if small business).

• Any GSA Schedule or other government-wide contract information.

• Domestic manufacturing status.

• Technical specifications for the proposed solution.

• Responses are due by March 6, 2026.

• Submit responses via email to Reagan.davis@fda.hhs.gov.

• Subject line: Sources Sought Notice Number: SSN_CDER-2026-131687 – Mass Spectrometer.

• This is a Sources Sought Announcement for market research only. No contract will be awarded from this announcement.

• No reimbursement for costs associated with providing information.

• No RFQ package or solicitation exists.

• Technical Point of Contact information will not be provided.

Sources Sought Notice

This is a market survey notice issued by the U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), on behalf of CDER/OPQ/OPQR. The FDA is seeking to identify vendors capable of providing a high-resolution, accurate mass spectrometer system with Ultra-High-Performance Liquid Chromatography (UHPLC) capabilities. This equipment is needed to support the Office of Pharmaceutical Quality Research – St. Louis (OPQR – St. Louis) in characterizing drug substances and drug products for potential nitrosamine impurities, small molecules, and macromolecules, aiding domestic drug manufacturing.

• One high-resolution mass spectrometer system with UHPLC capabilities.

• The system should have extended mass range up to m/z 12,000 for large biomolecule analysis.

• Must feature fast and sensitive electron-based fragmentation (ETD/EThcD) and enhanced sensitivity/dynamic range with eDR scan mode.

• The system will be used for identifying nitrosamine drug substance related impurities (NDSRIs) and comprehensive biotherapeutic characterization.

• The requirement includes delivery, installation, qualification, and instrument familiarization.

• The contractor shall demonstrate proper operation and performance upon installation and qualification.

• Contract period: 12 months from award.

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

• Total Period of Performance: 2 years.

• 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.

Interested vendors must provide:

• Company name, address, Cage Code, and UEI.

• Recommended NAICS code (specifically for Mass Spectrometers).

• Company size and socio-economic status (if small business).

• Any GSA Schedule or other government-wide contract information.

• Domestic manufacturing status.

• Technical specifications for the proposed solution.

• Responses are due by March 6, 2026.

• Submit responses via email to Reagan.davis@fda.hhs.gov.

• Subject line: Sources Sought Notice Number: SSN_CDER-2026-131687 – Mass Spectrometer

This is for market research only and not a solicitation. No contract will be awarded from this announcement. No reimbursement for costs associated with providing information. Proprietary information should not be submitted.