DINAMIQS has announced it has received the manufacturing and testing license from Swissmedic for viral vector cGMP production.
The Siegfried company is now authorised to manufacture and release Advanced Therapeutic Medicinal Products (ATMP) under GMP conditions.
Swissmedic has some of the highest quality and compliance standards in the industry. Combined with Switzerland's mutual recognition agreements with both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), products manufactured under Swissmedic oversight then benefit from streamlined acceptance pathways across Europe and the United States, significantly reducing regulatory friction and accelerating time-to-market.
The license designates DINAMIQS as Switzerland's first fully integrated viral vector CDMO, providing end-to-end capabilities from process development to drug product fill and finish, all within a single facility.
Martin Kessler, CEO of DINAMIQS: "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 programmes faster to the 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."
Eduard Ayuso, CTO and co-founder of DINAMIQS: "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 2500 m2 cGMP facility is purpose-built for viral vector manufacturing at scales up to 1000 L, integrating process development, drug substance production, aseptic fill-finish, and quality control testing in a single location.
Designed in accordance with EU GMP Annex 1, the facility features a modular, segregated layout and closed, single-use technologies, ensuring high containment, operational efficiency and full regulatory compliance for the European market.
DINAMIQS has successfully produced more than 300 batches of Adeno-Associated and Lenti Virus vectors, with the first batch produced in the new cGMP facility achieving best-in-class yields and quality.