Ardena, a 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.

The company now has capacity for large molecule biologics, including proteins, next to oligonucleotides (DNA, recombinant RNA, synthetic RNA, RNA vaccines) and peptides.

In a statement, the company said that the increased capabilities complements Ardena’s existing strengths in drug substance development and manufacturing.

The facility uses ARaymond Life’s RayDyLyo push-fit caps in the vial-capping process. This simplifies the sealing process, resulting in greater efficiency, flexibility, and faster time-to-clinic, according to the compay. In addition, it addresses the growing need for aseptic manufacturing, especially for novel parenteral therapies, by enhancing drug sterility, quality, and reducing risks.

Harry Christiaens, CEO of Ardena, said, “Receiving the GMP license for our new aseptic fill-finish facility is testament to our commitment to quality, compliance and dedication to navigating our customers through drug development. This milestone represents a significant step towards our vision of becoming a key CDMO for innovative drugs and is particularly vital when synergized with our existing nanomedicine development and manufacturing capabilities.”