The FDA’s Center for Biologics Evaluation and Research granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic for its nanoneedle/Tessie platform used to multiplex genome and capsid titer measurements in AAV gene therapy manufacturing. The designation provides the company and its customers prioritized regulatory engagement and potential acceleration for IND/BLA interactions. NanoMosaic said Tessie directly measures full‑length transgene integrity and capsid titers from crude and purified samples, enabling high‑throughput, low‑consumption QC that could reduce variability in AAV process development and release testing. CEO Philippe Mourere and co‑founder Qimin Quan highlighted the platform’s ability to generate novel critical quality attributes. Regulators’ endorsement of an analytical QC technology reflects growing FDA interest in modernizing analytical toolsets for cell and gene therapies and may lower regulatory friction for developers adopting NanoMosaic’s assay as part of manufacturing control strategies.