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Manufactures MVA EBOZ for Phase I trial
March 16, 2015
By: Kristin Brooks
Managing Editor, Contract Pharma
Emergent BioSolutions, Inc. has signed several agreements with the University of Oxford, GSK, and the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) respectively, for the manufacture of a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) for use in a Phase I trial. The study will evaluate the safety of MVA EBOZ as a heterologous boost to GSK’s Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate. Emergent performed proof of concept work and manufactured the MVA EBOZ vaccine candidate at a 200L scale in an avian cell line previously licensed to the company. Manufacturing in this cell line does not require eggs for the manufacturing process, and improves consistency of manufactured vaccine lots, and increases the doses delivered. The first clinical lot of the MVA EBOZ vaccine candidate is now complete and is undergoing acceptability and release testing. The scalable process has the potential to meet the demand for multi-million doses in a few months. “Emergent is pleased to be collaborating with the Jenner Institute, Oxford University, NIAID, and GSK to advance this MVA EBOZ vaccine candidate into a Phase I study,” said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. “Emergent is well-positioned for this unique opportunity given our long standing expertise in MVA product development and our MVA manufacturing capabilities utilizing a proprietary avian cell line to which we hold rights. This is the first time an MVA EBOZ vaccine candidate has been produced at a 200L scale in an avian cell line and we look forward to continuing this collaborative effort to address this public health threat.” Emergent manufactured the MVA EBOZ vaccine candidate at its Bayview Campus, Baltimore, MD, which is equipped with disposable manufacturing technology such as single use bioreactors that enable production of viral and non-viral products with a quick turnaround. This facility has been designated by the U.S. Department of Health and Human Services as a Center for Innovation in Advanced Development and Manufacturing (CIADM) that helps facilitate the development and manufacture of medical countermeasures to address public health threats.
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