Ascend Advanced Therapies Achieves GMP Certification for Quality Control in Munich Facility

Ascend Advanced Therapies Achieves GMP Certification in Munich

Ascend Advanced Therapies, a prominent player in the gene therapy sector, has successfully attained Good Manufacturing Practice (GMP) certification for Quality Control (QC) testing at its facility located in Munich, Germany. This critical certification marks a significant milestone for Ascend, enabling them to conduct advanced quality assessments for adeno-associated virus (AAV)-based gene therapy products.

The certification process, which concluded with a joint inspection conducted by the Upper Bavaria government and the Paul-Ehrlich-Institute in September 2024, validates the integrity and quality of Ascend's operations within the highly regulated domain of gene-based therapies. Karl Heller, the Vice President and Head of the Munich site, expressed pride in this accomplishment: "Building on our world-class innovation and development capabilities, the GMP certification enables streamlined stability testing and the release of higher quality AAV-based gene therapy products."

Advancements in Quality Testing

Ascend's Munich facility is now authorized to carry out sophisticated commercial assays targeting various critical parameters relevant to AAV production. These include assessments for DNA impurities and quantifying vector genome and capsid titers using cutting-edge methodologies such as droplet digital PCR (ddPCR) and automated ELISA.

The transition to these advanced techniques signifies a substantial improvement in the testing process. ddPCR, for instance, enhances reliability while eliminating dependency on reference standards commonly used in traditional methods like qPCR. Furthermore, the implementation of automated ELISA not only elevates reproducibility but also accelerates processing times and boosts throughput. These advancements are particularly vital, as the manufacturing of AAVs often deals with low volumes and high costs.

Mike Stella, CEO of Ascend, emphasized their commitment to innovation and excellence: "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."

Future Developments

In conjunction with the recent GMP certification, Ascend has plans to expand its testing capabilities further. Additional methods, including potency assays, are expected to be integrated into the Munich facility’s GMP license by the end of 2025. The company is also actively working on expanding its GMP operations in Alachua, Florida, to bolster commercial capabilities in conjunction with fill-and-finish services for gene therapies.

Ascend Advanced Therapies was founded to streamline the pathway for advanced therapy development, already achieving significant growth since its inception in early 2023. The company first expanded its capabilities by acquiring manufacturing assets from Freeline Therapeutics, who had years of expertise in AAV development. Following this, Ascend further broadened its reach in early 2024 by acquiring additional GMP assets from Beacon Therapeutics located in Alachua, Florida.

The company continues to strengthen its position in the advanced therapy landscape by aligning with partners like ABL, Inc. This collaboration aims to enhance development, manufacturing, and fill/finish capabilities significantly across multiple product categories, including gene therapies, vaccines, and immunotherapies.

With a robust portfolio of foundational investors, including top-tier venture capital firms and healthcare partners, Ascend is set to impact the gene therapy field significantly. By delivering comprehensive CMC support backed by decades of therapeutic development experience, Ascend is adept at guiding clients from the conceptual stage through to commercialization—all while keeping a keen focus on maximizing yield, quality, and cost efficiency.

For more information about Ascend and the latest updates on their developments, visit www.ascend-adv.com or follow them on LinkedIn.

Conclusion

The GMP certification of the Munich facility represents not only a rigorous validation of Ascend Advanced Therapies' operational standards but also reflects a growing commitment to advancing gene therapy solutions in Europe. As the organization moves forward, it is well-poised to lead in the rapidly evolving landscape of advanced therapies, ensuring that innovative treatments reach those who need them most.