Stunner AF system

Department of Health and Human Services

Forecast Overview

NAICS
334516
Performance end
8/2026

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.

Source

Source
HHS SBCX Forecast Export
Source file
Forecast.csv
Official source
Agency forecast source
Last verified
2026-08-31

Agency-published contact: · nick.sartain@fda.hhs.gov

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