23.09.2014 13:32:16
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Emergent Begins Study To Support Licensure Of BioThrax Production At New Plant
(RTTNews) - Vaccine maker Emergent BioSolutions Inc. (EBS) Tuesday said it began its fifth and final study to show that producing its anthrax vaccine in a new building with higher capacity is comparable to producing it in the approved building.
The new Building 55 has the potential to triple manufacturing capacity to an estimated 20 to 25 million doses annually, the company said in a statement
The randomized, observer-blinded study aims to show the consistency of three BioThrax vaccine lots made in Building 55 based on lot-to-lot equivalence, as well as to show the comparability of the three Building 55 lots with a Building 12 lot based on non-inferiority.
Both Building 55 and the approved Building 12 are located in Emergent's Lansing, Michigan campus.
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