Advanced Freeze Dryer
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- 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 seeking to procure an Advanced Freeze Dryer for lyophilization research to support drug manufacturing and regulatory processes. The procurement is categorized under Analytical Laboratory Instrument Manufacturing (NAICS 334516) with an estimated solicitation release date of November 1, 2025, and an anticipated award date of January 1, 2026. The contract aims to acquire a lyophilizer with advanced process monitoring and control capabilities to support research on complex generics, biologics, and essential medicine manufacturing.
While specific award values are not provided, the forecasted opportunity targets supporting approximately 70% of FDA-approved antibiotic and injectable drug manufacturing processes. The equipment will be utilized by the FDA's Office of Pharmaceutical Quality and Regulatory Research (OPQR) to develop science-based regulatory standards, conduct facility inspections, and enhance staff training capabilities. The primary point of contact for this opportunity is Christopher Scott, who can be reached at christopher.scott@fda.hhs.gov, representing the Food and Drug Administration.
Forecast text
Approximately 70% of FDA-approved antibiotics and most injectable drugs use lyophilization (freeze-drying) during manufacturing. OPQR conducts lyophilization research to support review of generic and new drugs, facility inspections, staff training, and guidance development for these critical drug products. The proposed equipment will support complex generics, biologics, and essential medicine manufacturing and product quality research. The lyophilizer with advanced process monitoring and control capabilities will support assessment of manufacturing quality, develop science-based regulatory standards. This equipment will strengthen FDA's ability to ensure the safety, efficacy, and quality of lyophilized drugs that reach patients.
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