The U.S. Food and Drug Administration (FDA) completed its Pre-Approval Inspection (PAI) of Emergent BioSolutions, Inc.’s Building 55 for the large-scale manufacturing of BioThrax (anthrax vaccine adsorbed).
Following the PAI’s conclusion, Emergent BioSolutions received a No Action Indicated decision and no Form 483 observations.
The successful completion of a PAI is one of the requirements for Building 55 licensure in connection with Emergent BioSolution’s supplemental Biologics License Application (sBLA) that was recently accepted by the FDA. The sBLA has a Prescription Drug User Fee Act target action date of Aug. 15.
“Emergent is pleased to have reached this critical milestone in our BioThrax comparability program,” Adam Havey, executive vice president and president of the biodefense division at Emergent BioSolutions, said. “The positive outcome from this pre-approval inspection is a testament to our employees’ tireless efforts, to our substantial financial investment in Building 55, and to our strong partnership with BARDA. We look forward to timely completing the process for securing FDA licensure of our facility.”
The Biomedical Advanced Research and Development Authority has fully funded the BioThrax comparability program at $104 million.
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.
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.
Building 55 is located at Emergent BioSolution’s manufacturing facility in Lansing, Michigan.