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.
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.
“We are proud to offer our clients a full-service solution, starting from formulation development and analytical method validation, all the way through to regulatory support and bioanalysis.”
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.
Christiaens added: “Our flexible approach and focus on small batch sizes cater to the specialized needs of early-stage clinical development and personalized medicines. This flexibility means that we can efficiently handle small quantities. By eliminating the constraints of minimum batch sizes, we empower our customer to optimize their resources, reduce waste, and streamline the development process, ultimately accelerating the journey of innovative treatments from the lab to the clinic.
“We understand that in drug development one size does not fit all, and our commitment to adaptable manufacturing reflects our dedication to tailored solutions for every client’s unique journey.”