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Friday, May 20th, 2022

FDA approves sBLA for Biothrax manufacture at Emergent BioSolutions’ Building 55

The U.S. Food and Drug Administration (FDA) recently approved Emergent BioSolutions, Inc.’s supplemental Biologics License Application (sBLA) for the manufacture of BioThrax (Anthrax Vaccine Adsorbed) at the company’s large-scale Building 55 manufacturing facility in Lansing, Michigan.

BioThrax, the only FDA-license anthrax vaccine, is indicated for both pre- and post-exposure prophylaxis of anthrax disease. Emergent BioSolutions has supplied the Strategic National Stockpile with BioThrax since 2001 in support of the U.S. government’s biosecurity and preparedness efforts.

“FDA approval of Building 55 is the culmination of more than a decade of investment and collaboration by Emergent and the U.S. government towards the ability to manufacture anthrax vaccines at large scale to protect the nation,” Daniel J. Abdun-Nabi, president and CEO of Emergent BioSolutions, said. “This milestone represents the U.S. government’s continued commitment to anthrax preparedness and its belief in the company’s core competency in manufacturing and the potential of this facility. The expanded capacity of Building 55 also positions the company to potentially supply anthrax vaccines to allied governments in support of their preparedness plans.”

The use of Building 55 to manufacture BioThrax could expand manufacturing capacity to an estimated 20 to 25 million doses annually. Manufacturing BioThrax at a larger scale will also allow Emergent BioSolutions to meet the government’s goal of stockpiling 75 million doses of a licensed anthrax vaccine.

The program was executed with the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services under contract HHSO100201000034C, which is valued at $104 million.