Emergent BioSolutions Inc. today announced that it has initiated manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) consistency lots in Building 55, following review by the U.S. Food and Drug Administration (FDA) of the Manufacturing and Non-Clinical Study Protocols submitted by the company supporting the Building 55 comparability program. The goal of the comparability program is to generate data that will show BioThrax manufactured at large scale in Building 55 is comparable to the BioThrax currently manufactured in the approved facility, Building 12. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease.
“Emergent is pleased to have reached an agreement with FDA that now enables the final steps towards securing approval of Building 55 for large scale manufacturing of BioThrax. This progress could not have been achieved without the successful collaboration between the company, FDA, and BARDA,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “This multi-year effort to expand our manufacturing capability is intended to address the U.S. Government’s stated need for this critical medical countermeasure in the Strategic National Stockpile. We look forward to our continued partnership with the government to bring this program to completion.”