Emergent BioSolutions Inc. announced on June 21 that the U.S. Food and Drug Administration (FDA) has completed its Pre-Approval Inspection (PAI) of Building 55, the company’s facility for large-scale manufacturing of BioThrax (Anthrax Vaccine Adsorbed).
At the conclusion of the inspection, the company received a No Action Indicated decision and no Form 483 observations. Successful completion of the PAI is one of the requirements for Building 55 licensure in connection with the company’s supplemental Biologics License Application (sBLA) recently accepted by the FDA. The sBLA has a target action date of August 15, 2016.
“Emergent is pleased to have reached this critical milestone in our BioThrax comparability program. 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,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “We look forward to timely completing the process for securing FDA licensure of our facility.”
The BioThrax comparability program is fully funded at $104 million by the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.