Ardena, an integrated CDMO, 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 roller compaction equipment, a WP120 Pharma from Alexanderwerk, enables the CDMO 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 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 joins the company with more than 25 years of experience in the pharmaceutical industry and expertise in pharmaceutical particle engineering technologies and respiratory products.