#USA #FDA Approval #gene therapy #Waltham #Nanomosaic

NanoMosaic Achieves FDA AMT Designation

On January 29, 2026, NanoMosaic announced that it has secured the FDA's Advanced Manufacturing Technology (AMT) designation for its pioneering Nanoneedle technology, which is designed for multiplex testing of vector genome and capsid titers utilized in AAV (adeno-associated virus) gene therapy manufacturing. This important recognition comes from the FDA’s Center for Biologics Evaluation and Research (CBER) and highlights NanoMosaic's commitment to driving innovations in gene therapy analytics.

The Significance of AMT Designation

The FDA's AMT designation is aimed at encouraging the adoption of advanced manufacturing technologies that can substantially enhance the development and production processes of biopharmaceuticals. By receiving this designation, gene therapy developers using the NanoMosaic platform will benefit from improved engagement and expedited reviews for their Investigational New Drug (IND) and Biologics License Applications (BLA).

Philippe Mourere, CEO of NanoMosaic, expressed, "Obtaining an AMT designation is a powerful testament to NanoMosaic's vision to introduce novel, regulatory-relevant Critical Quality Control Measures that meaningfully advance gene therapy manufacturing." This designation marks a significant milestone for the company and asserts their vision of enhancing gene therapy development while also reducing regulatory uncertainties for developers.

Advanced Analytical Capabilities

The unique capabilities of NanoMosaic's platform allow for high-throughput, multiplex analysis of critical attributes in AAV manufacturing. Unlike conventional methods that indirectly infer genome quality, the Nanoneedle technology enables direct measurement of full-length transgene integrity alongside capsid titers, providing unparalleled insights into vector potency and batch consistency. This not only reduces sample usage and testing time but also mitigates variability in results, hence enhancing overall quality control processes.

Qimin Quan, Co-Founder and Chief Scientific Officer, stated, "The NanoMosaic technology is designed to support the entire lifecycle of gene therapy products including development, quality control, and release testing. The AMT designation instills confidence in our developers to adopt advanced, multiplex testing strategies, significantly speeding up gene therapy development."

Future Endeavors

Following this noteworthy achievement, NanoMosaic is poised to expand its offerings beyond AAV applications to other viral and non-viral modalities. This expansion aims to push the boundaries of modern gene therapy analytics even further, heightening the ability to measure critical quality attributes throughout the lifecycle management of advanced therapy products.

About NanoMosaic

Founded as a pioneering biotechnology firm, NanoMosaic focuses on developing cutting-edge tools and technologies for multimodal biomarker detection and analysis. The flagship Tesla™ system boasts the capability to analyze multiple types of biological samples with high sensitivity and accuracy. By improving the processes in both biomarker detection for research and clinical applications, NanoMosaic aims to foster advancements in disease diagnosis, drug discovery, and personalized medicine.

For further information about the FDA’s Advanced Manufacturing Technology Designation Program, please visit the FDA AMT Guidance page. For additional insights on NanoMosaic’s unique multiplex analytical platform, head over to www.nanomosaicllc.com.

As innovation leads the charge in gene therapy analytics, NanoMosaic stands at the forefront, committed to enhancing the standards of global health care.