Public Health Emergency - Leading a Nation Prepared
Author: Robin Robinson, Ph.D, Director of the Biomedical Advanced Research and Development Authority, Deputy Assistant Secretary for Preparedness & Response, U.S. Department of Health and Human Services Published Date: 11/17/2014 4:45:00 PM
Category: Medical Countermeasures; Response & Recovery;
Leveraging experience and investments to help respond to the Ebola outbreak
BARDA is moving forward in innovative ways to close the gap in vaccines and therapeutics needed to protect the public’s health from Ebola. One promising therapeutic candidate is ZMapp, a unique monoclonal antibody therapeutic that consists of three antibodies targeting the Ebola virus. These antibodies, which are produced in genetically modified tobacco plants, are combined together in a “cocktail” that has shown great promise in animal studies. So far it has been used to treat five patients, four of whom have survived. This is great news, of course, but it is too early to make any claims about the product’s efficacy based on this limited data.
On September 2, 2014, BARDA awarded a contract to Mapp Biopharmaceutical to accelerate the development and testing of ZMapp. BARDA is providing funding as well as technical assistance to scale up manufacturing of ZMapp. We hope to have enough drug by January 2015 to begin clinical studies with ZMapp and increasing quantities will be available over time for additional clinical studies as we improve our capability to manufacture it.
BARDA routinely provides assistance to vaccine and therapeutic manufacturers to help them increase the production capacity of their products to commercial scale. BARDA is currently supporting the manufacture of sufficient doses of ZMapp for initial clinical safety and efficacy studies and it is working with other domestic manufacturers who can produce monoclonal antibodies in tobacco plants in order to maximize the production of ZMapp.
In addition to providing direct support to Mapp Biopharmaceutical, BARDA is utilizing its Centers for Innovation in Advanced Development and Manufacturing (CIADMs) to produce monoclonal antibodies like those found in ZMapp to fight Ebola. The CIADMs were established in 2012 to develop and manufacture medical countermeasures during a public health emergency. In parallel, we are working with other manufacturers to develop and manufacture other Ebola monoclonal antibodies using specialized mammalian cells and state-of-the art antibody development and manufacturing technologies.
Once a therapeutic drug or, in this case, monoclonal antibody cocktail has been produced, it will still need to be packaged and vialed for use in clinical settings. As part of our pandemic preparedness efforts, BARDA established a Fill Finish Manufacturing Network to fill vials and finish packaging after the product has been produced. This network, which celebrated its first anniversary last month, will be used to formulate and fill Ebola antibody and vaccine products into vials for studies and other uses.
We have these capabilities today because of the effective plans and investments that we put in place starting in 2010. Because of these investments, we may be able to produce a lifesaving medical countermeasure against Ebola more quickly today. The Ebola crisis is validating these investments in real time.
These national assets will serve us well and highlight how important such investments are. They stand among ongoing preparedness efforts that better position us nationally to deal with Ebola and other public health threats.
Leveraging the assets, partnerships, and processes we’ve established over the past decade, we will fight this epidemic more effectively, expand the options for preventing and treating Ebola, and ultimately defeat this threat to our national and global health security.
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