The FDA’s Center for Biologics Evaluation and Research (CBER) granted an Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s nanoneedle/Tessie multiplex QC platform, recognizing it as a regulatory‑relevant tool for AAV gene therapy manufacturing. NanoMosaic said the designation will enable prioritised interactions and expedited engagement on critical quality attributes for vector genome and capsid titers. NanoMosaic’s Tessie platform performs high‑throughput, multiplexed measures of full‑length transgene integrity and capsid titers from crude and purified samples, aiming to reduce sample consumption and assay variability. Company leadership framed the AMT mark as validation that the technology can improve process control and accelerate product development timelines. Separately, NanoMosaic reiterated that regulatory recognition of measurement platforms can lower uncertainty for developers of AAV gene therapies and support broader adoption of standardized CQAs across the sector. The AMT decision arrives as sponsors seek faster, more reliable analytics to support scale‑up and licensing submissions.