Stunner AF system
Past Recompete Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Not on record
- Estimated value
- $25,000 to $250,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- Points of contact
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
FDA's Center for Biologics Evaluation and Research (CBER) is recompeting a contract for the Stunner AF analytical system or equivalent, a multi-attribute characterization platform capable of measuring genome packaging efficiency, dynamic light scattering, UV-Visible absorbance, and fluorescence from a single 2 microliter sample in high-throughput plate-based format to support characterization of Adeno-Associated Virus (AAV) vectors and Lipid Nanoparticles (LNPs). The estimated award date is August 1, 2026; the contract includes four 1-year post-warranty service agreement options.
The estimated award value ranges from $25,000 to $250,000. FDA's contracting officer is Nick Sartain, reachable at nick.sartain@fda.hhs.gov or 301-796-1988.
Forecast text
FDA, Center for Biologics Evaluation and Research (CBER), has a requirement for an analytical system with advanced, integrated multi-attribute characterization platform to enable characterization of Adeno-Associated Virus (AAV) vectors and Lipid Nanoparticles (LNPs). The laboratory develops next-generation AAV vectors and evaluates their immunogenicity and quality attributes. A critical need is the ability to measure genome packaging efficiency (empty/full ratio), which is the most important CQA for AAV products. The instrument must simultaneously measure dynamic light scattering (DLS) for particle sizing, UV-Visible absorbance for concentration quantification, and fluorescence for encapsulation efficiency (EE%) determination - all from a single, low-volume (2 L) sample in a high-throughput plate-based format. The Unchained Labs Stunner AF system or equal system, will allow measurement of all four CQAs from a single 2 L sample in one run. The requirement also has four 1-year post-warranty service agreement options.
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