Emergent BioSolutions Inc. recently received approval by a regulatory agency under the German Federal Ministry of Health for its large-scale manufacturing facility in Michigan, paving the way for the company to market its anthrax vaccine BioThrax in Germany and other countries.
Emergent said its facility in Lansing, Michigan, known as Building 55, is designed to supply approximately 20 to 25 million doses of BioThrax per year. The Paul-Ehrlich-Institut (PEI), the regulatory agency in Germany, approved the facility that manufactures BioThrax, an anthrax vaccine licensed by PEI for pre-exposure prophylaxis of anthrax disease.
With the approval of Building 55, Emergent said the approval of its manufacturing facility would expand its capacity to supply BioThrax to a broader customer base while fulfilling U.S. government requirements. Since receiving licensure from the U.S. Food and Drug Administration in August 2016, the company has begun to supply BioThrax manufactured in Building 55 to the U.S. Strategic National Stockpile.
“Emergent is pleased with PEI approval of our large-scale manufacturing facility, Building 55, which comes on the heels of Building 55 licensure by the FDA,” Adam Havey, executive vice president of Emergent BioSolutions, said.
“With this regulatory milestone, the company believes it is well-positioned to pursue BioThrax licensure across targeted countries within the European Union. This is in line with our strategy and supports our efforts to expand international sales as well as maximize utilization of our manufacturing infrastructure and capabilities,” he said.
Germany was the first country in the European Union to approve the sale of BioThrax, which authorized the manufacturing of the vaccine in 2013. BioThrax is also the only anthrax vaccine licensed by the FDA for both pre-exposure and post-exposure prevention of anthrax disease.
Emergent BioSolutions, a global specialty biopharmaceutical company, develops and manufactures a variety of medical countermeasures to combat biological and chemical threats.