Ardena’s New State-of-the-Artwork Nanomedicine Facility Secures Full GMP Approval for Manufacturing

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OSS, The Netherlands, Nov. 19, 2024 (GLOBE NEWSWIRE) — Ardena, a specialist pharmaceutical Contract Growth and Manufacturing Organisation (CDMO) with GMP services in Belgium, Spain, the Netherlands, and Sweden, publicizes the complete Good Manufacturing Apply (GMP) approval of its expanded nanomedicine facility in Oss. Granted by the Dutch Healthcare Authority, the approval allows GMP manufacturing operations for nanomedicines, marking a significant milestone in Ardena’s mission to assist purchasers in bringing modern therapies to clinic and to market.

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The approval follows a €20 million funding in a state-of-the-art 45,000 sqft facility providing GMP-compliant Grade C and Grade D cleanrooms designed particularly for nanomedicine manufacturing. The fit-for-purpose cleanrooms, alongside further GMP manufacturing areas, devoted laboratories for course of growth and analytical capabilities, and superior warehouse services, mirror Ardena’s dedication to assembly stringent regulatory requirements, together with the most recent updates to Annex 1 for the manufacture of sterile merchandise.

Jeremie Trochu, CEO of Ardena, commented: “Reaching full GMP approval for our manufacturing operations is a big step ahead for Ardena. This accomplishment underscores our dedication to equipping purchasers with world-class capabilities for the event and manufacturing of complicated nanomedicine formulations. We’re happy with our workforce’s dedication to sustaining the very best regulatory and high quality requirements.”

The expanded capabilities embrace manufacturing and GMP launch of nanomedicines. These merchandise embrace superior nanoparticulate drug supply techniques, in addition to imaging brokers and tissue engineering merchandise. The ability is provided to deal with a variety of nanomedicines, together with lipid-based nanoparticles (resembling LNP’s, liposomes, and lipid micelles), polymeric nanoparticles (resembling polymer micelles and dendrimer-based nanoparticles), and steel/steel oxide nanoparticles (resembling gold, silica, and iron oxide nanoparticles).

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The Oss facility additionally contains purpose-built automated manufacturing flows, and absolutely built-in analytical capabilities for characterizing complicated nanomedicine formulations. These enhancements permit Ardena to scale its operations whereas sustaining the very best requirements of high quality, productiveness, and shopper satisfaction.

“Our nanomedicine facility is among the only a few CDMO websites worldwide devoted completely to nanomedicine growth and manufacturing,” Trochu added. “We’re uniquely positioned to satisfy the evolving wants of this fast-growing sector. This achievement exemplifies Ardena’s capacity to ship cutting-edge options and assist our purchasers in bringing life-changing therapies to sufferers.”

Ardena’s nanomedicine capabilities are additional bolstered by its built-in service providing. Trochu added: “We assist nanomedicine initiatives with a completely built-in strategy, together with aseptic fill-finish capabilities and bioanalysis experience. This in-house mixture allows seamless, end-to-end assist for scientific provide, a important benefit for injectable nanomedicine formulations.”

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For extra info on Ardena’s nanomedicine capabilities, please go to https://nanomedicines.ardena.com/

About Ardena

Ardena is a number one Contract Growth and Manufacturing Group in superior drug growth of latest, modern, and complicated molecules. Ardena’s mission is to allow present and next-generation therapies to get into the clinic and to sufferers quicker. Ardena assists biopharmaceutical firms in navigating by the drug discovery and growth course of to create efficient and compliant drug substances and merchandise for scientific trials, by offering built-in companies together with strong state chemistry, API, and nanomedicine growth and manufacturing, analytical and formulation growth, drug product manufacturing, bioanalytical and CMC regulatory companies.

A photograph accompanying this announcement is accessible at https://www.globenewswire.com/NewsRoom/AttachmentNg/d1a45dde-e9da-4b1a-a233-9720be060297

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