Biogen Inc. today announced that its next generation manufacturing facility in Solothurn, Switzerland has received a Good Manufacturing Practice (GMP) multi-product license from the Swiss Agency for Therapeutic Products (SWISSMEDIC).
The Solothurn facility combines Biogen’s latest concepts for fed-batch cell culture technology and protein purification, enabling the large-scale production of biopharmaceuticals. With more than 500 employees, the highly modernized facility design consists of multiple bio-manufacturing cells (BMCs) with site infrastructure in place to support future BMCs if needed. The GMP licensure is an important step in the readiness of the site, which enables the future submissions of product files to regulatory authorities. Notably, the site could support the manufacturing of aducanumab if approved, expanding on Biogen’s existing capacity in Research Triangle Park, North Carolina, as well as the potential manufacturing of lecanemab (BAN2401) and other biologic assets.
“GMP licensure is a foundational and critical step forward towards our Solothurn manufacturing site creating, safeguarding and supplying high quality medicine to patients,” said Nicole Murphy, Head of Global Manufacturing and Technical Operations at Biogen. “We are excited about the potential of our state-of-the-art manufacturing site in Switzerland where innovation is driven by our highly talented workforce.”
As part of Biogen’s sustainability goals, the Solothurn facility has implemented design features to keep emissions to the lowest level possible with the goal to become fossil fuel free by 2040. The building design and equipment will help to generate 83% fewer carbon emissions, will lower energy consumption by 79% and will reduce water usage per kilogram of output by 89%.