The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Tessie gene therapy QC platform, giving the Waltham, Massachusetts firm prioritized regulatory interactions for its nanoneedle‑based AAV analysis system. The designation recognizes Tessie’s ability to measure full‑length transgene integrity and capsid titers directly from crude batches, offering potential new critical quality attributes (CQAs) for AAV manufacturing. NanoMosaic’s CEO Philippe Mourere said the AMT status will accelerate engagement with developers and reduce regulatory uncertainty for gene therapy makers adopting the platform. Tessie’s capability to multiplex proteins and nucleic acid readouts on the same run is presented as a manufacturing analytics advance that could shorten batch release timelines and improve potency assessments. The FDA’s AMT program aims to bolster robust, scalable manufacturing for cell and gene therapies. For developers, the designation may translate into earlier CMC conversations, potentially faster IND and BLA reviews, and clearer expectations for novel CQAs tied to vector integrity and potency. Adopters and CDMOs will watch how regulators integrate new CQAs into filings; broader uptake could reshape analytical standards for AAV process control and comparability strategies during scale‑up.