High Resolution Mass Spectrometer
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $700,000 to $1,500,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- Points of contact
-
- Christopher Scott christopher.scott@fda.hhs.gov
- tbd@fda.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration (FDA) is forecasting the procurement of a High Resolution Mass Spectrometer (LC-HRMS) system with high sensitivity capabilities for genotoxic impurity testing and impurity profiling of complex drug products. This critical analytical laboratory instrument will support the agency's mission by providing advanced data analysis for characterizing biopharmaceuticals, with specific emphasis on supporting GDUFA and OMUFA user fee program needs. The estimated solicitation release date is December 1, 2025, with an anticipated award date of February 1, 2026.
The procurement falls under NAICS code 334516 for Analytical Laboratory Instrument Manufacturing, with no specific set-aside designation. Key points of contact include Christopher Scott from the FDA, who can be reached at christopher.scott@fda.hhs.gov. The instrument will include sophisticated software for processing MS data, with a specific package for analyzing oligonucleotide data to enhance the agency's laboratory capabilities in evaluating the quality of increasingly complex drug products. While specific award values are not disclosed, the instrument is positioned as a high-throughput analytical solution for the FDA's comprehensive drug assessment processes.
Forecast text
LC-HRMS system with high sensitivity to support the needs of genotoxic impurty testing of human medicines and high resolution and high sensitifity needed for impurity profiling of complex drugs (e.g., peptide and protein drug products). The instrument supports the agency mission by providing data needed to assess complex drug products that are an increasing share of the US drug supply. These work-horse instruments have the capability for high throughput analysis. Software is used for the analysis of MS data for the characterization of biopharmaceuticals and the update includes a package for processing oligonucleotide data will imrove agency lab capability to provide needed information on the quality of these complex drugs. The instrument will primarily support GDUFA and OMUFA user fee program needs.
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