Emergent BioSolutions (EBS) And FDA Finalize Comparability Protocols Enabling Manufacturing Of Biothrax Consistency Lots In Building 55
4/22/2014 8:05:22 AM
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has initiated manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) consistency lots in Building 55, following review by the U.S. Food and Drug Administration (FDA) 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.
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