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
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.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 seeking to procure a High Resolution Liquid Chromatography-Mass Spectrometry (LC-HRMS) system with high sensitivity and resolution capabilities to support genotoxic impurity testing of human medicines and impurity profiling of complex drug products, including peptides and proteins. The instrument must demonstrate high throughput analysis capability and include software packages for analyzing mass spectrometry data and processing oligonucleotide data to assess biopharmaceutical quality. The solicitation is expected to be released on August 1, 2025, with an estimated award date of February 1, 2026.
The estimated award value ranges from $700,000 to $1,500,000 for this new requirement under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing). This procured instrument will primarily support the FDA's GDUFA and OMUFA user fee programs and enhance the agency's laboratory capability to evaluate the increasing share of complex drug products in the U.S. drug supply. Interested vendors should direct inquiries to the FDA's Acquisition Liaison at cderacquisitions@fda.hhs.gov.
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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