Emeryville
The biomanufacturing facilities at the Emeryville Supply Center produce Betaseron®* (Interferon beta-1b), which accounts for 85 percent of the overall production volume at the facility. For the remaining 15 percent, Bayer presently serves as the contract manufacturer for Proleukin, Menjugate and PDGF for Novartis. All employees at the site are involved in the manufacturing of these four products.
Betaseron® was approved in the U.S. in 1993 and in the EU in 1995 for the treatment of relapsing forms of multiple sclerosis. It is the No. 2 revenue-generating product in the Bayer HealthCare (BHC) profile at 20 million dosages, or $1.5 billion in sales, annually. The manufacturing of Betaseron is divided into three main process units: fermentation, purification, and aseptic fill & lyophization. It takes each process unit approximately one week to produce approximately 100,000 vials.
* BETASERON® (Interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
Important Safety Information
The most commonly reported adverse reactions are lymphopenia, injection-site reaction, asthenia, flu-like symptom complex, headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. BETASERON should be used with caution in patients with depression. Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information.
