Ascend Advanced Therapies, a gene-to-GMP development service provider, 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 up processing, and supports significantly higher throughput. Both methods also require small sample volumes for analysis, an important benefit given that AAV manufacturing typically involves low volumes and high costs.
"At Ascend, our philosophy is to aim higher in everything we do. Our whole team is driven to empower the commercialization of the best advanced therapies on the market. We will continue to make critical investments and build on this foundation to support customers at any stage of their development journey," Mike Stella, CEO at Ascend concluded.
Additional methods such as potency assays are planned to be added to the Munich GMP license through 2025, and GMP expansions continue in Alachua, FL to support commercial activities and fill-finish.