CDMO Profile

Ardena

Ardena Contract Manufacturing & Development (CDMO) Profile



Ardena is a fully integrated CDMO with a core focus on bringing molecules to the clinics.

Our full-service offering covers:

• Drug Substance: Navigating your small-molecule API project through route scouting, development and manufacturing under accelerated timelines.

• Solid State Research: Our High Throughput Screening methodology for salt, co-crystal, polymorph, and amorphous form screening speeds up the selection of a solid form qualifying for development.

• Drug Product: Our expertise includes phase-appropriate development and manufacturing under cGMP conditions, as well as clinical packaging and logistics. We count with bioavailability enhancement technologies and expertise, such as spray drying.

• Nanomedicines: As a leading CDMO for nanomedicines, we provide scalable formulation, process, and analytical development as well as GMP manufacturing, enabling our customers to reach their clinical schedules in time.

• CMC Regulatory Services: With in-depth understanding of scientific writing, CMC documentation requirements, and regulatory processes, Ardena fast-tracks your product towards global approval.

• Bioanalysis: We offer solutions for all types of drug products and biomarkers, from small molecules to proteins including antibodies, ADCs, oligonucleotides and vaccines.

CDMO Services:
API and/or Ingredients; Finished Dosage Forms (Small Molecule Drugs) Liquids; Semi-solids; Solids; Sterile Vials Analytical Development; Drug Delivery System; Formulation Development; ICH Stability Testing; Process Development

Year Founded: 2017

Head Office: Mariakerke, Belgium

Number of Facilities: 45415

Facility locations: Europe

Website: Visit the Ardena website

Linkedin: Connect on Linkedin

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