Emergent Bio Files sBLA for Expanded BioThrax Manufacturing

Emergent BioSolutions has submitted a supplemental BLA seeking approval for manufacturing BioThrax (anthrax vaccine adsorbed) at the company’s large-scale manufacturing facility (Building 55). The submission is supported by data that demonstrate that BioThrax manufactured in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility, according to the company. 

BioThrax is the only FDA-licensed anthrax vaccine and it is indicated for both pre-exposure and post-exposure prophylaxis of anthrax disease. Since 2001, the company says it has been supplying BioThrax to the Strategic National Stockpile to support the U.S. government's biosecurity and preparedness efforts. “Building 55 has the potential to expand manufacturing capacity of BioThrax to an estimated 20 to 25 million doses annually from the seven to nine million doses produced annually out of the currently-licensed facility,” Emergent says.