Description
The FDA’s Gene Therapy Immunogenicity Branch seeks a turnkey, integrated analytical instrument capable of multi‑attribute characterization of Adeno‑Associated Virus (AAV) vectors and Lipid Nanoparticles (LNPs). The system must measure four critical quality attributes (genome packaging efficiency, aggregation, viral genome concentration, capsid concentration) from a single 2 µL sample, support up to 96 samples per run, and include UV/Vis, fluorescence, and Dynamic Light Scattering (DLS/RADLS) capabilities. The award includes delivery, installation, on‑site training, a one‑year manufacturer warranty, and up to four optional post‑warranty service years. Delivery must occur within 100 calendar days of award, with the base contract firm‑fixed‑price and options evaluated on total price. • Provide a Stunner AF or equivalent system with integrated UV/Vis, fluorescence, DLS/RADLS. • Perform all AAV CQAs from a 2 µL sample in one run. • Support 96‑sample batch runs and LNP payload/encapsulation analysis. • Include software, calibration materials, installation, and in‑person training. • Offer optional 1‑year renewable service agreements for up to four years. • Deliver to FDA/CBER, Silver Spring, MD; complete installation within 100 days of award.