Stunner AF system

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.

Estimated value

> $25K and < $250K

Anticipated award

Aug 1, 2026

• NAICS334516
• PSC334516