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April 22, 2014
07:07 EDTEBSEmergent BioSolutions initiates manufacturing of BioThrax lots in Building 55
Emergent BioSolutions announced that it has initiated manufacturing of BioThrax consistency lots in Building 55, following review by the U.S. Food and Drug Administration 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. The Manufacturing and Non-Clinical Study Protocols reviewed with FDA specify the criteria by which product manufactured in Building 55 will be determined as comparable to BioThrax currently produced in Building 12. The company has initiated manufacturing consistency lots of BioThrax in Building 55 to demonstrate comparability and for use in the pivotal non-clinical study, which is scheduled to begin this year. Data from this non-clinical study, together with the comparability data from these consistency lots, will be used to support a Prior Approval Supplement to the BioThrax licensed BLA for the approval of Building 55. Building 12 produces 7 to 9 million doses of BioThrax annually. Building 55 has the potential to triple manufacturing capacity to an estimated 20 to 25 million doses annually.
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