The FDA’s Center for Biologics Evaluation and Research awarded an Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle platform for multiplexed testing of AAV vector genome and capsid titers. The designation recognizes the technology’s potential to improve efficiency, product quality, and scalability in AAV gene‑therapy manufacturing. NanoMosaic says Nanoneedle directly measures full‑length transgene integrity and capsid titers across crude and purified samples, reducing sample use and assay time versus conventional tests. The company positioned the platform for upstream/downstream process development, quality control, release testing and lifecycle management of AAV products. Regulatory validation via AMT can accelerate industry adoption of the assay for potency and batch consistency assessment, offering developers a route to tighter QC and faster process optimization in gene‑therapy workflows.