Bayer in the Bay Area
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Bayer HealthCare has had a strong presence in the Bay Area for decades. As the second-largest biotech employer in the region, we boast manufacturing and development operations locally and have consolidated our U.S. research efforts at our U.S. Innovation Center here in Mission Bay. Our footprint in the Bay Area includes every step of the process: from early-stage research and innovation through partnerships and licenses with the goal of development through manufacturing. We are poised to deliver the next generation of biotherapeutics that address unmet medical needs and improve human health. With two decades of experience in producing complex protein therapies, the Berkeley site functions as the headquarters for Bayer’s biotechnology product supply organization as well as the global manufacturing center for Kogenate ® , a recombinant factor VIII treatment for hemophilia A. Bayer HealthCare is broadly engaged in education throughout the Bay Area. Through volunteering and internships, we provide hundreds of local students their first window into a science career. We work to develop programs and policies, and support existing excellence as well as new approaches. We help scale up funded projects that show intriguing results. Bayer's global commitment to corporate citizenship encompasses active support of our patients and the communities where we work and live. In the Bay Area, Bayer is an award-winning leader — through both grants and volunteerism — in science education, environmental sustainability and a range of patient support organizations. Our aim is not just to make a contribution; it is to make significant change. Bayer HealthCare in the Bay Area STEM EDUCATION Bayer’s grants and employee activism in the Bay Area are supported by a company- wide pledge to finding solutions for major issues. From bioswales to our 86 percent recycling rate, we share the City of Berkeley’s priorities and commitment to environmental sustainability. We have helped grow educational opportunities in our local communities by funding public libraries, elementary school science labs and Berkeley’s YMCA Teen Center. ABOUT KOGENATE ® FS Kogenate ® FS, antihemophilic factor (recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate ® FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage. IMPORTANT SAFETY INFORMATION The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections. Kogenate ® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins. For important risk and use information, please see the full Prescribing Information at www.kogenatefs.com/prescribing-information.jsp. INDICATIONS AND USAGE 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 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. Severe hepatic injury, including cases of hepatic failure, has been reported. Patients should be monitored for liver enzyme elevations while taking BETASERON ® . BETASERON ® should be used with caution in patients with seizure disorders or cardiac disease. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. The most commonly reported adverse reactions are lymphopenia (low numbers of a certain kind of white blood cell), injection-site reaction, asthenia (general weakness), flulike symptom complex (flu syndrome and/or a combination of at least two Adverse Events from fever, chills, muscle aches, tiredness and sweating), headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information. For important risk and use information, please see the full Prescribing Information. For more information about the Betaseron ® Pregnancy Registry, please visit BetaseronPregnancyRegistry.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch, or call 1-800-FDA-1088. LOCAL PHILANTHROPY Biomanufacturing Expertise at Berkeley The biomanufacturing facilities at the Emeryville Supply Center produce Betaseron ® (Interferon beta-1b). 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 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 roughly 100,000 vials. Emeryville Facilities Corporate Citizenship
Transcript of Bayer in the Bay Area
Bayer HealthCare has had a strong presence in the Bay Area for decades. As the second-largest biotech employer in the region, we boast manufacturing and development operations locally and have consolidated our U.S. research efforts at our U.S. Innovation Center here in Mission Bay. Our footprint in the Bay Area includes every step of the process: from early-stage research and innovation through partnerships and licenses with the goal of development through manufacturing. We are poised to deliver the next generation of biotherapeutics that address unmet medical needs and improve human health.
With two decades of experience in producing complex protein therapies, the Berkeley site functions as the headquarters for Bayer’s biotechnology product supply organization as well as the global manufacturing center for Kogenate®, a recombinant factor VIII treatment for hemophilia A. Bayer HealthCare is broadly engaged in
education throughout the Bay Area. Through volunteering and internships, we provide hundreds of local students their first window into a science career. We work to develop programs and policies, and support existing excellence as well as new approaches. We help scale up funded projects that show intriguing results.
Bayer's global commitment to corporate citizenship encompasses active support of our patients and the communities where we work and live. In the Bay Area, Bayer is an award-winning leader — through both grants and volunteerism — in science education, environmental sustainability and a range of patient support organizations. Our aim is not just to make a contribution; it is to make significant change.
Bayer HealthCarein the Bay Area
STEM EDUCATION
Bayer’s grants and employee activism in the Bay Area are supported by a company-wide pledge to finding solutions for major issues. From bioswales to our 86 percent recycling rate, we share the City of Berkeley’s priorities and commitment to environmental sustainability. We have helped grow educational opportunities in our local communities by funding public libraries, elementary school science labs and Berkeley’s YMCA Teen Center.
ABOUT KOGENATE® FS
Kogenate® FS, antihemophilic factor (recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate® FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.
IMPORTANT SAFETY INFORMATION
The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.
Kogenate® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
For important risk and use information, please see the full Prescribing Information at www.kogenatefs.com/prescribing-information.jsp.
INDICATIONS AND USAGE
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
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. Severe hepatic injury, including cases of hepatic failure, has been reported. Patients should be monitored for liver enzyme elevations while taking BETASERON®.
BETASERON® should be used with caution in patients with seizure disorders or cardiac disease. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. The most commonly reported adverse reactions are lymphopenia (low numbers of a certain kind of white blood cell), injection-site reaction, asthenia (general weakness), flulike symptom complex (flu syndrome and/or a combination of at least two Adverse Events from fever, chills, muscle aches, tiredness and sweating), headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms.
See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information. For important risk and use information, please see the full Prescribing Information. For more information about the Betaseron® Pregnancy Registry, please visit BetaseronPregnancyRegistry.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch, or call 1-800-FDA-1088.
LOCAL PHILANTHROPY
BiomanufacturingExpertise at Berkeley
The biomanufacturing facilities at the Emeryville Supply Center produce Betaseron® (Interferon beta-1b). 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 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 roughly 100,000 vials.
Emeryville Facilities
Corporate Citizenship
