Ascend Advanced Therapies (Ascend), a gene-to-GMP development partner, has received GMP certification for Quality Control (QC) testing at its site in Munich, Germany. „The team successfully completed a joint inspection by the government of Upper Bavaria and the Paul-Ehrlich-Institute in September of 2024,“ said Karl Heller, VP and Head of Site at Munich. „Building on our world-class innovation and development capabilities, the GMP certification enables streamlined stability testing and release of higher quality AAV-based gene therapy products.“ The Munich facility is now certified to perform advanced commercial assays for DNA impurities, vector genome titer, capsid titer and process residuals using state-of-the-art techniques, including droplet digital PCR (ddPCR) and automated immunoassay. These methods offer key advantages over traditional approaches like qPCR and manual ELISA: ddPCR provides high robustness and removes the need for reference standards, while automated immunoassay improves reproducibility, speeds…