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One of the nation’s centers dedicated to developing and manufacturing drugs and vaccines for emergencies will produce a therapeutic drug to treat Ebola virus disease through a new agreement with the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR). The first-of-its-kind action supports the ongoing global public health response to the Ebola epidemic in West Africa.
The Center for Innovation in Advanced Development and Manufacturing (CIADM) led by Emergent BioSolutions of Gaitherburg, Md., will begin advanced development and manufacturing activities for its first experimental monoclonal antibody drug under the two-year, $19.7 million agreement with the ASPR’s Biomedical Advanced Research and Development Authority (BARDA).
The Emergent facility in Baltimore is one of three CIADMs established as public-private partnerships with BARDA in 2012 to respond rapidly to national needs for medical countermeasures. Over the last three years, the CIADM partners have designed and built out necessary physical infrastructure, including facilities and manufacturing lines, for the centers.
BARDA has used the CIADMs to develop and manufacture fundamental components of influenza vaccines to protect against viruses with pandemic potential, such the H7N9 influenza virus, for preparedness purposes but has not previously called on them to manufacture medical countermeasures for use in an ongoing epidemic.
For this new work, Emergent will transfer manufacturing processes and materials from the early-stage development work of other companies on this experimental drug to the CIADM to begin advanced development. Emergent also will manufacture the experimental drug for use in clinical studies and conduct the work necessary to scale up production to commercial volumes if clinical studies prove successful.
The experimental drug is similar to ZMapp, made by Mapp Biopharmaceuticals of San Diego using tobacco plants. This new drug uses a combination of the same three monoclonal antibodies as ZMapp, but is produced using special mammalian cells rather than tobacco. Monoclonal antibodies bind to key viral proteins and neutralize a virus, decreasing the amount of the virus in the body that the patient's immune system has to fight.
Because large quantities of cell-based monoclonal antibodies can be produced more quickly than tobacco-based monoclonal antibodies, this CIADM project will provide more product for clinical studies and, if clinical studies are successful, for potential stockpiling.
“Preventing, detecting and treating Ebola infections remains critical not only for the current epidemic in West Africa but also to minimize the impacts of future outbreaks,” explains BARDA director Robin Robinson, PhD. “The development of this experimental drug represents significant progress in making Ebola therapeutics available. Our CIADM partners have the expertise, capacity, and state-of-the-art facilities required to make promising therapeutic candidates quickly.”
The CIADMs were established in the wake of the 2009 H1N1 influenza pandemic and are a component of BARDA’s National Medical Countermeasures Response Infrastructure that provides core services for private partners to speed development, manufacturing and availability of drugs, vaccines and medical devices including diagnostic tests. Other core services provided through the response infrastructure include a nonclinical studies network, a clinical studies network, and a fill-finish manufacturing network.
The National Medical Countermeasures Response Infrastructure and development of Ebola therapeutic drugs are part of BARDA’s integrated portfolio approach to advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, emerging infectious diseases, and antimicrobial resistance.