Author: Jane Edwards|| Date Published: June 28, 2016
The Biomedical Advanced Research and Development Authority has awarded Emergent BioSolutions (NYSE: EBS) a potential $21.9 million task order to develop and produce a vaccine against Zika virus for use in the first phase of a clinical trial.
The company said Monday the order has a base period of 30 months worth $17.9 million and covers the production of up to three Zika vaccine lots that comply with Current Good Manufacturing Practice regulations.
The contract also includes analytical process development, small-scale production runs, cell banking to facilitate bulk manufacturing of the vaccine, and technology transfer of data and process materials.
BARDA, which is part of the office of the assistant secretary for preparedness and response at the Department of Health and Human Services, made the contract award as part of the Center for Innovation in Advanced Development and Manufacturing program.
HHS said Monday in a news release Emergent BioSolutions will also file an investigational new drug application with the Food and Drug Administration through CIADM in order to commence clinical studies.
BARDA has also supported the development of pathogen reduction platforms designed to reduce risks of Zika virus infections in the supply of blood products and has begun to collect blood samples through its network of clinical trials in an effort to expedite the development of diagnostic tests, HHS added.
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