Manufacturing Issues Crucial to Combating Ebola
A key challenge in testing and developing new therapies to combat the Ebola virus involves producing sufficient quantities of candidate treatments to conduct clinical trials and then to facilitate commercial scale-up for any product demonstrating effectiveness. Clinical trials are being launched for several promising Ebola therapies and vaccines, and successful results will require massive efforts to produce the millions of doses needed to treat and prevent further spread of the virus.
As part of a broader United States campaign to counter the Ebola outbreak, the federal government is ramping up support for formulation, production, and packaging of Ebola treatments. Heading this effort is the Biomedical Advanced Research and Development Authority (BARDA), a component of the Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), which works with biopharmaceutical and medical-products companies to develop and stockpile medical countermeasures against such biological threats as smallpox, anthrax, and pandemic influenza.
Now therapies for Ebola top BARDA’s priority list, as seen in its $25-million investment in testing and production of ZMapp, a combination of three monoclonal antibodies (mAbs) manufactured in tobacco plants by Mapp Biopharmaceuticals. Current efforts to expand production in both tobacco plants and in mammalian cell cultures aim to provide sufficient quantities for clinical trials, explained BARDA director Robin Robinson at a hearing before the House Energy & Commerce Health subcommittee on Nov. 19, 2014. BARDA has enlisted assistance of Genentech and Regeneron in developing mAb technologies capable of immediate commercial-scale production, and Amgen is working with the Gates Foundation to examine ways to make Zmapp in Chinese hamster ovary cells.
Robinson also announced that BARDA’s relatively new fill-finish manufacturing network has its first work order, a contract with network member Nanotherapeutics/Baxter to fill vials with Zmapp for clinical testing.