The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle/Tessie platform, recognizing the technology as a regulatory‑relevant approach for multiplexed quality control of AAV gene therapy products. The designation offers NanoMosaic prioritized engagement and potential expedited IND/BLA interactions for partners using the platform. NanoMosaic’s assays measure genome integrity and capsid titers directly from crude and purified samples, aiming to reduce sample consumption and assay variability in AAV manufacturing. The firm says Tessie can deliver actionable critical quality attributes (CQAs) in high throughput, which could shorten development timelines and improve batch consistency for developers of AAV vectors. GEN and company statements quoted the CEO and technical leads on how the AMT tag will support broader industry adoption and regulator engagement. For manufacturers and CMC teams, the designation signals a clearer regulatory path for novel analytical technologies that quantify vector potency and consistency.