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News Breaks
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.
News For EBS From The Last 14 Days
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May 22, 2015
14:49 EDTEBSEmergent BioSolutions files automatic mixed securities shelf
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May 19, 2015
07:06 EDTEBSEmergent BioSolutions signs manufacturing agreement with Prometic Life Sciences
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May 13, 2015
07:07 EDTEBSSoligenix signs development agreement with Emergent BioSolutions
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07:07 EDTEBSGSK, Emergent BioSolutions, Oxford initiate Prime Boost study of Ebola vaccine
A new phase 1 study has begun at the University of Oxford that will investigate the use of a modified vaccinia Ankara, or MVA, Ebola Zaire vaccine candidate, or MVA EBOZ, as a prime-boost to GlaxoSmithKline's (GSK) Chimp Adenovirus type 3, or ChAd3, Ebola vaccine candidate. The study, being conducted by the clinical research group of Professor Adrian Hill of the Jenner Institute, has received regulatory approval to begin from the United Kingdom's Medicines and Healthcare Products Regulatory Agency, or MHRA. The phase 1 study has a planned enrollment of 38 volunteers of which 6 will receive MVA EBOZ only while the other 32 will receive ChAd3-EBO-Z prime followed by MVA EBOZ boost. Emergent BioSolutions (EBS) manufactured the supply of MVA EBOZ to be used in this phase 1 study, which is being conducted in the U.K. with support from the Wellcome Trust and the U.K. Department for International Development.

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