The FDA’s Center for Biologics Evaluation and Research granted NanoMosaic an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle platform, which measures vector genome and capsid titers for AAV gene therapy manufacturing. Regulators said the AMT designation recognizes technologies that can materially improve efficiency, product quality and scalability in biologics production. NanoMosaic says the Nanoneedle enables multiplexed, high‑throughput molecular measurement of full‑length transgene integrity and capsid titers in crude and purified samples, reducing assay time and sample use. The designation is intended to accelerate industry adoption of regulatory‑relevant QC tools and could shorten qualification pathways for vector analytics in process development and lot release.