Advanced Freeze Dryer

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.

Estimated value

>= $250K and < $700K

Est. solicitation date

Jul 1, 2025

Anticipated award

Jan 1, 2026

• NAICS333415
• PSC333415