Ardena invests to further increase development and manufacturing capabilities for oral solid dosage forms and inhalation products at Pamplona site (former Idifarma) with new equipment and new capabilities.
Ardena, a fully integrated Contract Development and Manufacturing Organization (CDMO) assisting biopharma companies with services spanning all the development life cycle, has announced upgrades to its development and manufacturing facilities in Pamplona (Spain) with investments in dry granulation technology and upgrades to its spray drying capabilities.
The new roller compaction equipment, a WP120 Pharma from Alexanderwerk Inc, enables Ardena to offer a dry granulation service alongside its existing capabilities and expertise in wet granulation and direct compression/blending.
In addition, Ardena’s existing spray drying offering will be upgraded with ancillary equipment allowing the company to manufacture inhaled drugs. The investments will enable the Pamplona site to handle a wider range of moisture-sensitive compounds, increase yields, and manufacture with a variety of organic solvents like dichloromethane and chloroform.
“This investment allows us to develop drug formulations and manufacture clinical and small commercial batches with dry granulation. When added to our spray drying expertise, this means we can provide a wider range of formulation options to turn an amorphous solid dispersion into a finished dosage form in tablets or capsules,” said Ardena’s CEO, Harry Christiaens.
“Our scientific and technical capabilities in Pamplona allow us to work from formulation up to GMP manufacturing for clinical and commercial oral solid forms requiring solubility enhancement (BCS II and IV compounds with poor aqueous solubility) using spray drying as an established and scalable particle engineering technology, including all analytical methods and microbiological testing.
“Besides, we can handle highly potent compounds. This constitutes a distinctive combination in the CDMO market and something which our team is very proud of.”
Ardena has further strengthened its spray drying expertise with the appointment of Stefano Console from Swiss life sciences consultancy Oriento SA as Scientific Advisor. He comes with more than 25 years of experience in the pharmaceutical industry and expertise in pharmaceutical particle engineering technologies and respiratory products.
Christiaens added: “We are delighted to welcome Stefano, who shares our science-led approach needed to deliver valuable, phase-appropriate, and integrated solutions for our biopharma customers globally. He is a recognized authority in the field of spray drying.”
Ardena is an integrated service CDMO, assisting biopharma companies with services spanning the full development life cycle. The Company offers a comprehensive ‘Make, Analyze, File’ model from drug substance and drug product manufacturing and bioanalytical services through to regulatory dossier development.
With a strong reputation for quality and a flexible service delivery model, Ardena caters to a highly diversified base of over 300 customers throughout Europe, the US, Japan and Korea. A high science approach and broad drug development toolkit differentiate Ardena from peers as a comprehensive multi-service pan-European platform. For more information, please visit www.ardena.com