Bildnachweis: Siegfried.
DINAMIQS, a Siegfried company (SIX: SFZN), announces that it has received the manufacturing and testing license from Swissmedic for viral vector cGMP production. With this approval, DINAMIQS is now authorized to manufacture and release Advanced Therapeutic Medicinal Products (ATMP) under GMP conditions – marking a key step in supporting customers across the globe on their path to patients.
Swissmedic is internationally recognized for applying some of the highest quality and compliance standards in the industry. Switzerland’s mutual recognition agreements with both the European Medicines Agency and the U.S. Food and Drug Administration create a powerful advantage for developers: products manufactured under Swissmedic oversight benefit from streamlined acceptance pathways across Europe and the United States, significantly reducing regulatory friction and accelerating time to market.
The license establishes DINAMIQS as the first fully integrated viral vector CDMO in Switzerland offering end-to-end capabilities from process development to drug product fill and finish, all within a single facility. „Obtaining this 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. I also want to thank the entire DINAMIQS and Siegfried team: in less than four years, we have built a company that is able to serve customers globally at the highest quality standards, and this achievement is entirely the result of their dedication and excellence.“ says Martin Kessler (CEO, DINAMIQS).
Eduard Ayuso (CTO & Co-Founder, DINAMIQS) adds: „Since DINAMIQS began operations as a new CDMO focused on viral vectors, our guiding ambition has been to enable innovative therapies to reach patients. This vision has driven the company from its inception. Having now produced more than 300 preclinical batches, we are ready to raise the bar and support our clients with the supply of GMP grade material.”
Located in Zurich, the 2,500 m2 cGMP facility is purpose-built for viral vector manufacturing at scales of up to 1,000L. The facility integrates process development, drug substance production, aseptic fill-finish, and quality control testing in one place – reducing complexity, timelines, and technology transfer risks for customers. Designed in accordance with EU GMP Annex 1, the facility features a modular and segregated layout combined with closed, single-use technologies, ensuring high containment, operational efficiency, and full regulatory compliance for European market supply. DINAMIQS has successfully produced more than 300 batches of Adeno-Associated and Lenti Virus vectors. The first batch produced in the new cGMP facility achieved best-in-class results in terms of yield and quality.
