The U.S. FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Tessie platform for assessing gene therapy quality, enabling prioritized regulatory interactions for developers who adopt it. NanoMosaic said the nanoneedle-based Tessie system measures vector genome integrity and capsid titers from crude or purified samples, producing novel critical quality attributes (CQAs) relevant to AAV manufacturing. NanoMosaic’s CEO, Philippe Mourere, framed the designation as a milestone that will deepen industry partnerships and reduce regulatory uncertainty for gene therapy developers. The AMT status gives companies using Tessie earlier access to FDA engagement, potentially accelerating IND and BLA review timelines. The decision marks one of the first agency recognitions for a gene therapy analysis platform rather than a manufacturing automation method, signaling regulatory interest in new analytical tools that improve product potency and consistency.