FDA Vitrification instrument system

The FDA's Center for Biologics Evaluation and Research intends to procure a stand-alone benchtop vitrification instrument system for cryo-EM specimen preparation, with responses due July 13, 2026. This is a market-research sources-sought notice; responses do not obligate award or constitute adequate responses to future solicitations.

The system must perform automated flash freezing of biological samples in vitrified ethane to support vaccine research and regulatory analysis, including vaccine antigen morphology examination, antibody-antigen characterization, and viral particle evaluation. Technical requirements include programmable vitrification parameters (blotting time, blot force, wait time, drain time); environmental control maintaining +4°C to +60°C temperature and 0% to 100% humidity with real-time monitoring; compatibility with standard 3mm cryo-EM grids; dual-sided blotting with adjustable force and time; liquid ethane cryogen system with temperature monitoring and safety features; touchscreen interface with programmable protocols; enclosed working chamber with gas detection and ventilation compatibility; seamless integration with an existing Tundra Cryo-Transmission Electron Microscope; and minimum one-year full manufacturer's warranty. Delivery is FOB Destination to FDA CBER in Silver Spring, Maryland.

The FDA targets small businesses under NAICS 334516 (Analytical Laboratory Instrument Manufacturing) with up to 1,000 employees but welcomes large-business responses. Respondents must provide SAM Unique Entity ID, past performance on same or substantially similar products within three years, detailed technical specifications, estimated service initiation within five business days, pricing, country of origin for Buy American analysis, and GSA Schedule information if applicable. Responses submit to timothy.walbert@fda.hhs.gov by 2:00 pm Central Time with reference 75F40126SSN134450 in the subject line.