Biogen, awaiting FDA nod for $2B Swiss plant, plans to ship initial Aduhelm doses from North Carolina factory
https://www.fiercepharma.com/manufacturing/countdown-to-aducanumab-biogen-looks-to-start-shipments-alzheimer-s-drug-two-weeks-asBiogen has been beefing up manufacturing on both sides of the Atlantic ahead of a green light for its Alzheimer's disease drug aducanumab. Flush with an approval—and a label that could tee up millions of patients for treatment—it's ready to hit the ground running, the company's head of global manufacturing and technical operations said.
To gear up for the launch, the company has spent the past several years kitting out its facility in North Carolina's Research Triangle Park and building a bioprocessing plant in Solothurn, Switzerland, hiring more than 500 new employees along the way, manufacturing exec Nicole Murphy told Fierce Pharma. Biopharmaceutical manufacturing, which is complex, pricey and time-consuming, "takes a bit of an army," she explained.
Biogen will initially call on its facility at Research Triangle Park to supply the drug in the U.S., though it hopes to quickly bring its Swiss plant into the mix. There, the company figures it’s built enough capacity to supply the drug to more than 1 million patients per year, Murphy said....