Ardena’s expanded nanomedicine facility granted full GMP approval

The Netherlands facility is designed to handle a wide range of nanomedicines, including lipid-based nanoparticles

Ardena has announced the full Good Manufacturing Practice (GMP) approval of its expanded nanomedicine facility in the Netherlands by the Dutch Healthcare Authority.

The Oss facility is designed to handle a wide range of nanomedicines, including polymeric nanoparticles, lipid-based nanoparticles, as well as metal/metal oxide nanoparticles, the pharmaceutical Contract Development and Manufacturing Organisation (CDMO) outlined.

The authorisation follows a €20m investment in a 45,000 sq ft facility that comprises GMP-compliant Grade C and Grade D cleanrooms specifically designed for nanomedicine manufacturing.

The fit-for-purpose cleanrooms, in addition to GMP production spaces, advanced warehouse facilities, and dedicated laboratories for process development and analytical capabilities will support the company in meeting strict regulatory standards, such as the latest updates to the EU’s Annex 1 for the manufacture of sterile products, it said.

Also included within the facility are purpose-built automated manufacturing flows, and fully integrated analytical capabilities for characterising complex nanomedicine formulations.

Commenting on the authorisation, Ardena’s Chief Executive Officer, Jeremie Trochu, said: “Achieving full GMP approval for our manufacturing operations is a significant step forward for Ardena… We are proud of our team’s dedication to maintaining the highest regulatory and quality standards.”

“Our nanomedicine facility is one of the very few CDMO sites worldwide dedicated exclusively to nanomedicine development and manufacturing,” Trochu added. “We are uniquely positioned to meet the evolving needs of this fast-growing sector.”