The FDA’s Center for Biologics Evaluation and Research (CBER) granted NanoMosaic’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 NanoMosaic technology is designed to support upstream and downstream process development, quality control, release testing, and lifecycle management of gene therapy products,” says Qimin Quan, PhD, co-founder and CSO of NanoMosaic. The FDA’s approval for an AMT designation verifies the platform’s ability to enhance efficiency, product quality, and scalability across AAV gene therapy manufacturing, according to Philippe Mourere, CEO, NanoMosaic, who adds that 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. “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,” he continues. 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, points out Mourere. 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, he explains. The post Mosaic’s Nanoneedle Granted Advanced Manufacturing Technology Designation for Gene Therapy Products appeared first on GEN – Genetic Engineering and Biotechnology News.
