Emergent BioSolutions Receives BioThrax Approval
German Federal Ministry of Health approves the company’s Michigan facility for large-scale manufacturing
“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,” said Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions. “With this regulatory milestone, the company believes it is well-positioned to pursue BioThrax licensure across targeted countries within the EU. 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.”
In 2013, Germany became the first country in the EU to approve the sale of BioThrax through PEI market authorization of BioThrax manufactured in Building 12, the company’s original manufacturing facility. With the approval of Building 55, Emergent has expanded its capacity to supply BioThrax to a broader customer base while fulfilling U.S. government requirements. Building 55 is designed to manufacture approximately 20 million to 25 million doses of BioThrax annually. Since receiving FDA licensure in August 2016, the company has begun to supply BioThrax manufactured in Building 55 to the U.S. Strategic National Stockpile.
Visit Emergent BioSolutions at Interphex Booth 1240.