Ascend Advanced Therapies, a gene-to-GMP development partner, has achieved GMP certification for Quality Control testing at its Munich, Germany facility, marking a significant milestone in expanding European capacity for AAV-based gene therapy manufacturing and testing.
The certification was granted following a successful joint inspection by the government of Upper Bavaria and the Paul-Ehrlich-Institute conducted in September 2024. Karl Heller, VP and Head of Site at Munich, emphasized that the GMP certification builds on the company's innovation capabilities to enable streamlined stability testing and release of higher quality AAV-based gene therapy products.
Advanced Testing Capabilities
The Munich facility is now certified to perform advanced commercial assays for three critical parameters: DNA impurities, vector genome titer, and capsid titer. The facility employs state-of-the-art techniques, including droplet digital PCR (ddPCR) and automated ELISA, which offer significant advantages over traditional approaches.
According to the company, ddPCR provides high robustness and eliminates the need for reference standards compared to traditional qPCR methods. Meanwhile, automated ELISA improves reproducibility, accelerates processing, and supports significantly higher throughput compared to manual ELISA procedures. Both advanced methods require much smaller sample volumes for analysis, which is particularly beneficial given that AAV manufacturing typically involves low volumes and high costs.
Strategic Expansion Plans
The company has outlined plans to expand its testing capabilities further, with additional methods such as potency assays scheduled to be added to the Munich GMP license throughout 2025. Simultaneously, Ascend is continuing GMP expansions at its Alachua, Florida facility to support commercial activities and fill-finish operations.
Mike Stella, CEO at Ascend, stated that the company's philosophy is to "aim higher in everything we do" and that the entire team is driven to empower the commercialization of advanced therapies. He emphasized that Ascend will continue making critical investments and building on this foundation to support customers at any stage of their development journey.
Company Background
Ascend Advanced Therapies launched in early 2023 with the acquisition of Freeline Therapeutics Munich manufacturing assets and development team, bringing AAV development expertise dating from 1991. The company expanded its footprint in early 2024 by acquiring GMP manufacturing assets from Beacon Therapeutics in Alachua, Florida. In late 2024, Ascend aligned with ABL, Inc. to expand development, manufacturing and fill/finish capabilities for gene therapies, oncolytics, vaccines and immunotherapies.
The company's foundational investors include Abingworth, Anjinomoto, Cathay Health, Deerfield, Digitalis Ventures, DCVC Bio, EW Healthcare Partners, 4BIO Capital, Monograph, and Petrichor.
