- Ascend Advanced Therapies has received GMP certification for quality control testing at its Munich facility.
- The site will now support high-throughput, state-of-the-art assays for AAV-based gene therapy products.
Ascend Advanced Therapies has received GMP certification for quality control (QC) testing at its site in Munich, Germany. The approval follows a joint inspection conducted by the government of Upper Bavaria and the Paul-Ehrlich-Institute in September 2024.
The certification enables Ascend to perform commercial QC assays for AAV-based gene therapies. These include tests for DNA impurities, vector genome titer, capsid titer, and process residuals, using advanced methods such as droplet digital PCR (ddPCR) and automated immunoassays. These approaches are intended to improve analytical robustness, throughput, and accuracy while minimising sample volume requirements — a critical factor in AAV contract manufacturing.
Karl Heller, VP and Head of Site at Munich, noted the importance of the milestone: “Building on our world-class innovation and development capabilities, the GMP certification enables streamlined release and stability testing of higher quality AAV-based gene therapy products.”
According to the company, ddPCR offers benefits over qPCR by removing the need for reference standards, while automated immunoassays improve reproducibility and processing speed. Ascend also plans to expand its GMP licence in 2025 to include potency assays.
The company is continuing to invest in its manufacturing infrastructure. GMP expansions are ongoing at its Alachua, Florida site to support future commercial and fill-finish activities.
