The FDA’s CBER granted an Advanced Manufacturing Technology designation to NanoMosaic’s Nanoneedle platform for multiplex testing of AAV vector genome and capsid titers. NanoMosaic said the assay directly measures full‑length transgene integrity and capsid content in crude and purified samples, cutting sample use and assay time for gene‑therapy QC. The AMT designation signals regulatory receptivity for technologies that improve AAV potency, batch consistency and scalability during process development. NanoMosaic framed the regulatory nod as a step to broaden industry adoption of higher‑throughput, molecular‑level QC tools for AAV manufacturing.