Siegfried’s Dinamiqs secures Swissmedic license for viral vector GMP

Dinamiqs, a contract development and manufacturing organization (CDMO) headquartered in Zurich, Switzerland and part of Siegfried, has received a manufacturing and testing license from Swissmedic for viral vector production under current Good Manufacturing Practice (cGMP) conditions.

The license authorizes Dinamiqs to manufacture and release advanced therapy medicinal products (ATMPs), including gene therapies, supporting customers from development through clinical and commercial supply, according to the announcement. Swissmedic oversight is recognized for alignment with international regulatory standards, and the company said the approval may help streamline regulatory acceptance across Europe and the United States.

Dinamiqs said the approval establishes it as a fully integrated viral vector CDMO in Switzerland, offering capabilities from process development through drug substance manufacturing, fill-finish and quality control testing within a single facility. The Zurich site is designed to support production scales up to 1,000 liters using modular cleanroom layouts and single-use technologies, according to the company.

The CDMO said it has produced more than 300 preclinical viral vector batches to date and is now positioned to supply GMP-grade material for clinical programs.

The licensing milestone follows the opening of the Zurich facility in 2025, which the company said was the first of its kind in Switzerland designed to provide end-to-end viral vector manufacturing and reduce technology transfer complexity. The 2,500-square-meter facility was also part of parent company Siegfried’s broader growth strategy to expand its cell and gene therapy operations.