Ardena's Nanomedicine Facility secures full GMP approval for manufacturing
Oss, The Netherlands — Ardena has announced a significant milestone with its state-of-the-art nanomedicine facility at Pivot Park receiving full Good Manufacturing Practice (GMP) approval from the Dutch Healthcare Authority. This approval underscores Ardena’s commitment to advancing the development and manufacturing of complex nanomedicine formulations, catering to a growing demand for innovative therapeutic solutions.
The approval follows a €20 million investment in a state-of-the-art 45,000 sqft facility offering GMP-compliant Grade C and Grade D cleanrooms designed specifically for nanomedicine manufacturing. The fit-for-purpose cleanrooms, alongside additional GMP production spaces, dedicated laboratories for process development and analytical capabilities, and advanced warehouse facilities, reflect Ardena’s commitment to meeting stringent regulatory standards, including the latest updates to Annex 1 for the manufacture of sterile products.
Jeremie Trochu, CEO of Ardena, highlighted the significance of this development: “Achieving full GMP approval for our manufacturing operations is a significant step forward for Ardena. This accomplishment underscores our commitment to equipping clients with world-class capabilities for the development and manufacturing of complex nanomedicine formulations. We are proud of our team’s dedication to maintaining the highest regulatory and quality standards.”
The expanded capabilities include manufacturing and GMP release of nanomedicines. These products include advanced nanoparticulate drug delivery systems, as well as imaging agents and tissue engineering products. The facility is equipped to handle a wide range of nanomedicines, including lipid-based nanoparticles, polymeric nanoparticles and metal/metal oxide nanoparticles. The facility also includes purpose-built automated manufacturing flows, and fully integrated analytical capabilities for characterizing complex nanomedicine formulations.
“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. This achievement exemplifies Ardena’s ability to deliver cutting-edge solutions and support our clients in bringing life-changing therapies to patients.”
Read the full press release here.
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