Emergent BioSolutions, Inc., submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) on Monday for the approval of the manufacture of BioThrax (Anthrax Vaccine Adsorbed) in the company’s large scale Building 55 manufacturing facility.
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.
“Emergent is pleased to have reached this significant milestone in our BioThrax comparability program,” Adam Havey, executive vice president and president of the biodefense division at Emergent BioSolutions, said. “Anticipating that a typical FDA review of such a submission is four months, we expect the review process to be completed in the fall of this year. We believe that our submission conveys the robustness of our large-scale manufacturing process, the comparable product attributes, and the efficacy and consistency of the product from our new facility, supported by a variety of developmental and pivotal nonclinical studies. This milestone reflects many years of steadfast dedication from our project team and their effective collaboration with the U.S. government.”
The sBLA is supported by data demonstrating that BioThrax, when manufactured on a large scale in Building 55, is comparable to BioThrax that is manufactured in the currently-licensed facility. Emergent BioSolution’s sBLA submission follows the successful completion of re-analysis of data from one of more than 30 comparability assays for BioThrax manufactured in the new facility as requested by the FDA.
Emergent BioSolutions currently has the capability to produce up to nine million doses of BioThrax out of its currently-licensed facility. If approved, 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.