Pharma Focus America

Ardena to Expand Manufacturing Facility in Sweden

Introduction:

Ardena is nearly tripling the size of its Swedish facility, as part of a US $ 37 million investment across its European operations.

Features:

The company is making investments in the production of drug substances in Södertälje in order to increase capacity. These include a new production line, a larger preparative High-Performance Liquid Chromatography (HPLC), a new lyophilization unit, and additional large-scale synthesis machinery.

The facility will expand from its current 1500 m2 structure to a total footprint of over 4000 m2 for laboratories and office space by the end of 2023.

The additional capacity will enable production speeds that are four times faster than those possible with the existing preparative HPLC. A brand-new continuous process design for Tangential Flow Filtration/Ultrafiltration (TFF/UF) will allow for the purification and concentration of chemical compounds and APIs.

The new facility is scheduled to be installed and qualified in Q4 2022.

Lyophilization up to 55 litres will be operational by 2023 to increase the concentration and isolation of pure materials. Additionally, more reactors will be added to the 50- to 2300-liter scales of the synthesis machinery.

Specifications:

NameArdena
TypeExpansion
YearEnd of 2023
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