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
- 333415 Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment 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 is forecasting a new requirement for an Advanced Freeze Dryer to support lyophilization research and development activities. The equipment will feature advanced process monitoring and control capabilities to assess manufacturing quality, support review of generic and new drugs, conduct facility inspections, and develop science-based regulatory standards for complex generics, biologics, and essential medicine manufacturing. The solicitation is estimated to be released on July 1, 2025, with an anticipated award date of January 1, 2026.
The estimated award value for this contract ranges from $250,000 to $700,000, with the procurement classified under NAICS code 333415 for Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing. This freeze dryer will strengthen the FDA's Office of Pharmaceutical Quality and Regulatory (OPQR) ability to ensure the safety, efficacy, and quality of lyophilized drugs used in approximately 70% of FDA-approved antibiotics and most injectable drugs. Interested parties should direct inquiries to the FDA Acquisition Liaison at cderacquisitions@fda.hhs.gov.
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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