The FDA granted NanoMosaic an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle/Tessie platform that measures AAV vector genome integrity and capsid titers during gene therapy manufacturing. The agency’s designation is meant to accelerate regulatory engagement and could speed IND and BLA reviews for adopters of the technology. NanoMosaic’s platform enables multiplexed, high‑throughput testing of critical quality attributes (CQAs) from crude or purified samples and directly reports on full‑length transgene integrity—metrics that sponsors and manufacturers say are essential for potency and batch consistency. NanoMosaic positioned the designation as the first AMT granted for a gene therapy analysis platform. Regulatory validation of orthogonal QC tools increases options for developers aiming to de‑risk AAV supply chains and scale manufacturing. Companies building gene therapy programs may prioritize AMT‑designated assays to reduce variability in lot release testing and to secure more predictable regulatory interactions.