The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle platform for multiplex testing of AAV vector genome and capsid titers. The designation gives NanoMosaic enhanced regulatory engagement and prioritization intended to accelerate adoption of its Tessie assay for critical quality attribute (CQA) measurement in AAV manufacturing. NanoMosaic’s platform directly measures full‑length transgene integrity and capsid titers across crude and purified samples, promising faster QC cycles and reduced sample consumption. The AMT award highlights regulatory support for technologies that address bottlenecks in gene‑therapy scale‑up and product consistency, and it offers developers a clearer pathway for integrating novel QC assays into IND and BLA submissions.
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