The FDA’s Center for Biologics Evaluation and Research awarded NanoMosaic an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle/Tessie platform, which performs multiplexed testing of AAV vector genome and capsid titers. Company statements and GEN coverage note the designation provides enhanced FDA engagement, prioritized regulatory interactions, and the potential to streamline IND and BLA review for partners that adopt the platform. NanoMosaic said Tessie directly measures full‑length transgene integrity and capsid titers across crude and purified samples, reducing assay time, sample consumption, and variability compared with indirect methods. The AMT nod is the first FDA designation for a gene‑therapy analysis platform and positions NanoMosaic to offer critical quality attribute (CQA) testing that could accelerate process development and scale‑up amid rising demand for robust AAV analytics.