Analytical System with advanced, integrated multi-attribute characterization platform

Closed Solicitation Posted

Solicitation number
75F40126Q134650
Agency
FDA Office of Acquisition and Grant Services Food and Drug Administration, Department of Health and Human Services
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
334516 Analytical Laboratory Instrument Manufacturing
PSC
6630 Chemical Analysis Instruments
Place of performance
Silver Spring, Maryland 20993, United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The FDA Office of Acquisition and Grant Services seeks one Stunner AF analytical system (or equivalent) with UV/Vis absorbance, Dynamic Light Scattering/Rotating Angle Dynamic Light Scattering, and fluorescence capabilities to characterize Adeno-Associated Virus vectors and Lipid Nanoparticles, with proposals due August 26, 2026 at 1:00 P.M. Central Time. Amendment 1 was posted August 21, 2026.

This is an unrestricted full and open competition commercial item acquisition with no small business set-aside. Place of performance is Silver Spring, Maryland (FDA/CBER). The system must measure genome packaging efficiency, aggregation, viral genome concentration, and capsid concentration from a single 2-microliter sample in one run, accommodate up to 96 samples per run, and provide particle size and polydispersity data for LNP samples. The system must be newly manufactured and include all required software for instrument control and data analysis, installation, system setup, and in-person operator training. Delivery, installation, and training must be completed within 100 calendar days of contract award, with estimated delivery by December 10, 2026. NAICS code is 334516 (Analytical Laboratory Instrument Manufacturing) with a 1,000-employee small business size standard.

The contract is Firm Fixed Price and includes a one-year manufacturer's warranty followed by four optional one-year post-warranty service agreement periods, each providing one scheduled preventive maintenance visit annually, unlimited on-site corrective maintenance within three business days, unlimited software and firmware updates, and unlimited technical support Monday through Friday excluding federal holidays. All shipping and handling are included with FOB Destination to FDA/CBER. Payment is Net 30 days after government acceptance via the Department of Treasury's Invoice Processing Platform, with no advance payments allowed. Award goes to the lowest priced technically acceptable responsible quoter. Prices must remain firm through September 30, 2026. An Accessibility Conformance Report based on the Voluntary Product Accessibility Template is required. Offers should be sent to nick.sartain@fda.hhs.gov.

Notice text

2 versions

Update #2 · Latest ·

8/21/2026: See Amendment 1 attached.

See attached combined synopsis/solicitation.

Update #1 ·

See attached combined synopsis/solicitation.

Attachments

Files attached to this notice, newest first
File Type Posted
Amendment 1 combined synopsis-solicitation.pdf PDF
combined synopsis-solicitation.pdf PDF

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