Emergent: New BioThrax facility meets standards

An efficacy study on Emergent BioSolutions' new BioThrax production facility has concluded that production was comparable to an already approved facility, the company said on Friday.

The company intends to use the data from this study to streamline the process of having the facility approved so that increased production of BioThrax, an anthrax vaccine, can meet Strategic National Stockpile requirements. BioThrax manufactures the only approved vaccine against the disease.

The Rockville, Maryland-based company's first facility can produce up to 9 million doses, and the company said the second facility, in Lansing, Maryland, should be able to produce up to 25 million doses.

"(This) program represents years of collaborative efforts with BARDA and FDA to meet the U.S. government's stated requirement of 75 million doses in the Strategic National Stockpile," Adam Harvey, executive vice president and president of the Bio-Defense Division at Emergent BioSolutions, said. "Emergent is pleased with the completion of the in-life phase of our pivotal study. The remainder of 2015 will entail finalizing the nonclinical pivotal study report, progressing efforts related to the Prior Approval Inspection of the Lansing facility, and compiling the supplemental Biologics License Application (sBLA). We are continuing to work with FDA and anticipate approval in either late 2015 or early 2016."

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Emergent BioSolutions

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