NanoMosaic, a company specialising in advanced analytical technologies for cell and gene therapy development and manufacturing, has received an Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration’s (FDA) Centre for Biologics Evaluation and Research (CBER). The designation applies to the company’s proprietary Nanoneedle technology, designed for multiplex testing of vector genome and capsid titers in Adeno-Associated Virus (AAV) gene therapy manufacturing.

The AMT designation programme aims to accelerate the adoption of innovative manufacturing technologies that significantly improve the development and production of biopharmaceuticals. With this recognition, gene therapy developers using NanoMosaic’s platform can benefit from enhanced FDA engagement, prioritised regulatory interactions, and the potential for expedited Investigational New Drug (IND) and Biologics License Application (BLA) reviews.

According to the company, the FDA’s decision validates the platform’s ability to improve efficiency, product quality and scalability in AAV gene therapy manufacturing. NanoMosaic’s Nanoneedle technology enables high-throughput, multiplex analysis of key AAV quality attributes within a single workflow, reducing sample requirements, assay time and variability.

Unlike traditional methods that indirectly assess genome quality, the platform directly measures full-length transgene integrity and capsid titers at the molecular level in both crude and purified samples. This approach provides actionable insights into vector potency, batch consistency and overall process performance.

Philippe Mourere, Chief Executive Officer of NanoMosaic, described the designation as a milestone and an endorsement of the company’s strategy to introduce regulatory-relevant critical quality control measures in gene therapy manufacturing. He added that the recognition is expected to strengthen collaborations with gene therapy developers and manufacturers globally.

Qimin Quan, PhD, Co-Founder and Chief Scientific Officer, noted that the technology supports upstream and downstream process development, quality control, release testing and lifecycle management of gene therapy products. He added that the company is expanding the platform’s advanced capabilities to additional viral and non-viral therapeutic modalities.