Emergent BioSolutions initiates BioThrax manufacturing in Building 55
Emergent submitted manufacturing and non-clinical study protocols to support its Building 55 comparability program. The program seeks to generate data that shows BioThrax manufactured at large scale in Building 55 is comparable to the vaccines currently manufactured in Building 12, a previously approved facility.
BioThrax is the only vaccine licensed by the FDA 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," Adam Havey, the executive vice president and president of the biodefense division at Emergent, said. "This progress could not have been achieved without the successful collaboration between the company, FDA, and (the Biomedical Advanced Research and Development Authority)."
Emergent began manufacturing consistency lots of BioThrax in Building 55 to demonstrate comparability and for use in a non-clinical study. Data from the study, along with comparability data from the consistency lots, will be used to support a prior approval supplement to a biologics license application to manufacture BioThrax in Building 55.
While Building 12 produces seven to nine million doses of BioThrax annually, Building 55 may be able to triple manufacturing capacity to an estimated 20 to 25 million doses per year.
"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," Havey said. "We look forward to our continued partnership with the government to bring this program to completion."