Ardena, a CDMO headquartered in Belgium, will almost triple the size of its Swedish facility as part of a €35 million investment across its European operations. The firm is supporting drug substance manufacture in Södertälje to increase its capacity. It includes a new production line and a larger preparative HPLC system, as well as a new lyophilization unit and additional large-scale synthesis equipment.
The facility will grow from its current 1500 m2 building to a total footprint of over 4000 m2 for labs and office space by the end of 2023.
“By the end of 2023 Ardena will have increased GMP manufacturing capacity of our drug substance services including stand-alone purification and lyophilization capabilities,” says Harry Christiaens, CEO. “This investment is in line with expected growth and will allow us to continue to meet the requests of long-term customer collaborations, as well as bolster Ardena’s drug substance expertise.”
Scheduled to be installed and qualified in Q4 2022, the increased capacity will allow for a production speed four times higher than with the current preparative HPLC, he adds. A new Tangential Flow Filtration/Ultrafiltration (TFF/UF) will offer purification and concentration of APIs and chemical compounds using a continuous process design.
Lyophilization up to 55 liters for improved concentration and isolation of pure materials will be operational in 2023. Synthesis equipment ranging from 50 liters to 2300 liters scale will also be upgraded with more reactors.
“TFF enables us to concentrate and isolate pure material in a very time efficient manner,” Christiaens explains. “This new equipment, together with our present setup, results in a flexible and versatile manufacturing unit. We’re confident our continued investment in these technologies will be a huge benefit to our customers.”