- DINAMIQS has received a manufacturing and testing license from Swissmedic for viral vector cGMP production.
- The approval enables DINAMIQS to provide end-to-end CDMO services for genomic medicines, including process development and drug product manufacturing.
DINAMIQS, a Siegfried company, announced that it has received a manufacturing and testing license from Swissmedic for viral vector cGMP production. The approval authorizes the company to manufacture and release genomic medicines under GMP conditions, expanding Siegfried’s capabilities in advanced therapies and contract manufacturing.
The license positions DINAMIQS as an integrated CDMO for viral vector production, offering services from process development through to drug product manufacturing. The company stated that the approval supports its ability to provide end-to-end solutions for gene therapy developers.
The Zurich-based facility spans 2,500 square meters and is designed for viral vector manufacturing at scales of up to 1,000 liters. It integrates process development, drug substance production, aseptic fill-finish, and quality control testing. The facility is built in accordance with EU GMP Annex 1 requirements to support global regulatory compliance.
“The Swissmedic approval is a key step in scaling DINAMIQS into a leading viral vector CDMO. The approval strengthens the company’s position in advanced therapies and supports its global customer offering.”
Marcel Imwinkelried, CEO of Siegfried
DINAMIQS reported that it has produced more than 300 batches of adeno-associated and lentiviral vectors. The company stated that Swissmedic’s regulatory standards, along with mutual recognition agreements with international regulators, support efficient pathways for global market access.
