The expansion will be built at Bayer’s existing manufacturing facility in Berkeley.
"The new product testing facility will test Bayer's investigational products in accordance with rigorous global regulatory requirements," said David Weinreich, Head of Global Development, Specialty Medicine.
"With today's announcement, we are thrilled to further strengthen our commitment to the hemophilia A patient community that Bayer has served for more than a quarter century."
Bayer said the investment will create “325,000 hours of jobs” for local union contractors, “from glaziers to iron workers to sprinkler fitters.”
Bayer Healthcare’s US headquarters for R&D and biomanufacturing are in the Bay Area, spread between Berkeley and the US Innovation Center in San Francisco.
"As the Bay Area's third largest biotech employer, we are also proud to be making this contribution to the world's richest center of biotech R&D, investment, and production," said said Joerg Heidrich, Senior VP for Product Supply Biotech and Site Head at Bayer Berkeley.
Factor VIII
Bayer’s biggest approved haemophilia product is Kogenate (Factor VIII), a blood-clotting recombinant protein which is an alternative to Factor VIII derived from donated plasma. The product raked in €1.2bn ($1.28bn) in revenue in 2013. It can be given regularly to prevent bleeding episodes, or before surgery.
The US FDA is currently reviewing Bayer’s application for an updated biologic, BAY 8-8973 (provisional trade name Kovaltry), also a Factor VIII product for haemophilia A.
The compound showed success in three multinational clinical trials (the LEOPOLD programme, or Long-Term Efficacy Open-Label Program in Severe Haemophilia A Disease) as prophylaxis in adult and child patients with severe haemophilia (<1% FVIII:C).