The expansion will increase development and manufacturing for small molecules at the Södertälje facility with new equipment and increased capabilities to strengthen the firm’s existing expertise in drug substance manufacture.
Ardena, a fully integrated Contract Development and Manufacturing Organization (CDMO) assisting biopharma companies with services spanning across the development life cycle, is investing into almost trebling the size of its Swedish facility. The expansion in Södertälje is a part of Ardena’s €35 million investment across its European operations.
The firm is investing in drug substance manufacture in Södertälje to increase its capacity and includes a new production line and a larger preparative High Performance Liquid Chromatography (HPLC), 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.
Harry Christiaens, Ardena’s CEO, said: “By the end of 2023 Ardena will have increased GMP manufacturing capacity of our drug substance services including stand-alone purification and lyophilisation capabilities.
“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. A new Tangential Flow Filtration/Ultrafiltration (TFF/UF) will offer purification and concentration of API’s 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.
Christiaens added: “Ardena is an expert in purification and isolation, both of which are key steps in obtaining a high quality compound by using techniques such as chromatography, filtration and lyophilisation.
“TFF enables us to concentrate and isolate pure material in a very time efficient manner. This new equipment, together with our present setup, results in a very flexible and versatile manufacturing unit. We’re confident our continued investment in these technologies will be a huge benefit to our customers.”
Since 2005 Ardena has gained wide experience in chromatographic purification using state of the art equipment, successfully developing separation methods for both small and large molecules on gram to kilogram scale.
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