Biogen has received GMP certification at its Solothurn, Switzerland facility ahead of a regulatory decision for potential Alzheimer’s drug aducanumab.
Biogen commissioned the CHF 1 billion ($1 billion) monoclonal antibody production facility in Luterbach, Solothurn, in 2015, stating at the time it would offer 144,000 L of stainless-steel capacity, comprising of eight 18,000 L bioreactors with an output of 10 metric tons.
Last week, Swiss Agency for Therapeutic Products (SWISSMEDIC) granted the facility a Good Manufacturing Practice (GMP) multi-product license, “an important step in the readiness of the site, which enables the future submissions of product files to regulatory authorities,” according to the firm.
Additionally, “the site could support the manufacturing of aducanumab if approved, expanding on Biogen’s existing capacity in Research Triangle Park, North Carolina.”
Biogen has had a turbulent time with its proposed Alzheimer’s disease monoclonal antibody aducanumab. In 2015, data was announced that led the company to outline a Phase III study. Then in March 2019, late-stage results prompted Biogen to shelve the drug. Months later, the firm resurrected the program, after “new analysis of a larger dataset” showed the drug reduced clinical decline in patients with early Alzheimer’s disease.
The filing of the BLA submission has also been bumpy, but the end is in sight with a decision to be made by the US Food and Drug Administration (FDA) within the next two weeks.
“We are ready to launch aducanumab in the U.S. should we receive a regulatory approval, and we anticipate an FDA decision by the June 7 PDUFA date,” Biogen CEO Michel Vounatsos said last month.
“If approved, aducanumab will be the first therapy to meaningfully change the cost of Alzheimer’s disease and will represent a significant growth and value creation opportunity. Our cross functional team in the US has been working for months in preparation for the potential launch of aducanumab.”