Ardena, a leading Contract Development and Manufacturing Organization (CDMO) specializing in bringing molecules to clinic, has been granted a Good Manufacturing Practice (GMP) license by the Belgian Federal Agency for Medicines and Health Products (FAMHP) for its state-of-the-art aseptic fill-finish facility in Ghent, Belgium.
A significant step forward in Ardena's ability to provide full-service solutions for the development and clinical production of small molecules and large molecule biologics, the CDMO now has capacity for large molecule biologics, including proteins, next to oligonucleotides (DNA, recombinant RNA, synthetic RNA, RNA vaccines) and peptides.
The increased capabilities solidify Ardena's reputation as a trusted partner for drug development for clinical trials and complements Ardena's pre-existing strengths in drug substance development and manufacturing.
Ardena's cutting-edge aseptic fill and finish plant in Ghent is equipped with the latest technology, ensuring fast turnaround times, the highest quality standards, and a seamless experience for clients.
The facility uses ARaymond Life's RayDyLyo push-fit caps in the vial-capping process. This innovation simplifies the sealing process, resulting in greater efficiency, flexibility, and faster time-to-clinic. It addresses the growing need for aseptic manufacturing, especially for novel parenteral therapies, by enhancing drug sterility, quality, and reducing risks.
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