NanoMosaic Secures FDA Advanced Manufacturing Technology (AMT) Designation for Advanced Gene Therapy Analytics

• Gene therapy developers and manufacturers adopting NanoMosaic's platform gain access to enhanced FDA engagement and expedited IND/BLA review.
• The FDA AMT designation verifies NanoMosaic platform's ability to enhance efficiency, product quality, and scalability across AAV gene therapy manufacturing.

WALTHAM, Mass., Jan. 29, 2026 /PRNewswire/ -- NanoMosaic, a leader in advanced analytical technologies for cell and gene therapy development and manufacturing, today announced that the FDA's Center for Biologics Evaluation and Research (CBER) has granted the company's request for an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle technology for multiplex testing of vector genome and capsid titers in AAV gene therapy manufacturing. The FDA's approval of this request for an AMT designation verifies the platform's ability to enhance efficiency, product quality, and scalability across AAV gene therapy manufacturing.

The FDA's AMT designation program is intended to accelerate industry-wide adoption of advanced manufacturing technologies that fundamentally improve how biopharmaceuticals are developed and produced. Through this designation, gene therapy developers implementing the NanoMosaic platform gain access to enhanced FDA engagement, prioritized regulatory interactions and expedited IND and BLA review.

"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," said Philippe Mourere, Chief Executive Officer, NanoMosaic. "Recognition by FDA/CBER represents a major milestone for NanoMosaic and we view this designation as a strong encouragement to deepen our partnerships with gene therapy developers and manufacturers worldwide to accelerate gene therapy development and reduce regulatory uncertainty."

NanoMosaic's platform enables high-throughput, multiplex analysis of critical AAV quality attributes in a single workflow, significantly reducing sample consumption, assay time, and variability. Unlike conventional approaches that infer genome quality indirectly, this technology directly measures full-length transgene integrity and capsid titers in both crude and purified samples at molecular level, providing novel, actionable insights into vector potency, batch consistency, and process performance.

"The NanoMosaic technology is designed to support upstream and downstream process development, quality control, release testing, and lifecycle management of gene therapy products. This AMT designation gives developers confidence to adopt NanoMosaic's advanced, multiplex testing strategies, strengthening QC and accelerating development," said Qimin Quan, PhD., Co-Founder and Chief Scientific Officer, NanoMosaic. "Building on this major achievement, we are currently expanding the technology's advanced capabilities to other viral and non-viral modalities".

About NanoMosaic

NanoMosaic is a pioneering biotechnology company that develops innovative tools and technologies for multiomic biomarker detection and analysis. The company's flagship product, the NanoMosaic Tessie™ system, is a high-throughput platform for biomarker detection that enables researchers to analyze multiple samples simultaneously with high sensitivity and specificity across proteins and nucleic acid on the same run. The system is designed to provide novel Critical Quality Attributes (CQAs) for Cell and Gene Therapy development and manufacturing and to accelerate the discovery and development of biomarkers for a wide range of applications, including disease diagnosis, drug discovery, and precision medicine.

For more information on the FDA's Advanced Manufacturing Technology Designation Program, visit the FDA AMT Guidance page. Additional details about NanoMosaic's multiplex analytical platform are available at www.nanomosaicllc.com

Media Contact:
Philippe Mourere
CEO
NanoMosaic
Email: [email protected]

SOURCE NanoMosaic