DINAMIQS, a Siegfried company (SIX: SFZN) today announced that it has received a manufacturing and testing license from Swissmedic for viral vector cGMP production. With this approval, DINAMIQS is authorized to manufacture and release genomic medicines under GMP conditions, marking an important milestone in expanding Siegfried’s capabilities in advanced therapies and strengthening its offering to global customers.
The license positions DINAMIQS as a fully integrated viral vector Contract Development and Manufacturing Organization (CDMO) providing end-to-end services from process development to drug product manufacturing.
Marcel Imwinkelried, CEO Siegfried: “The Swissmedic approval is a key step in scaling DINAMIQS into a leading viral vector CDMO. It strengthens our strategic position in advanced therapies and underlines our ambition to provide fully integrated, high-quality solutions to customers worldwide.”
Martin Kessler, CEO DINAMIQS: “Obtaining the license is an important milestone on our journey. Our customers don’t just get GMP manufacturing – they get speed, reliability, and a clear path towards approval. We take complexity out of their way and help bring programs faster to clinic and market.”
Located in Zurich, the 2,500 m² cGMP facility is purpose-built for viral vector manufacturing at scales of up to 1,000L. It integrates process development, drug substance production, aseptic fill-finish, and quality control testing in one place, helping reduce complexity, timelines, and technology transfer risks for customers. Designed in accordance with EU GMP Annex 1, the facility ensures full regulatory compliance for global market supply. DINAMIQS has successfully produced more than 300 batches of Adeno-Associated and Lentiviral vectors, with the first batch from the new facility achieving best-in-class results in yield and quality.
Swissmedic is internationally recognized for its high quality and compliance standards. Switzerland’s mutual recognition agreements with the European Medicines Agency and the U.S. Food and Drug Administration support efficient regulatory pathways, facilitating broader market access for products manufactured under Swissmedic oversight.
With the Swissmedic license in place, DINAMIQS is well positioned to partner with gene therapy innovators worldwide, supporting the development and commercialization of next-generation therapies.
