US Looking to Boost Production of Experimental Ebola Drug
October 18, 2014 04:46
Rt.com
US officials have asked labs to submit plans for ramping up production of the experimental Ebola drug, Zmapp, of which supplies have run out. It successfully treated medical workers infected with the virus, but hasn't been widely tested for safety.
The US Department of Health and Human Services, through its BARDA division, issued the order for mass producing the antiviral cocktail on Thursday. Three advanced biological laboratories have until November 10 to submit detailed plans with budgets and timetables, according to Reuters.
The US government "is working with partners around the world as quickly as possible to advance the development of multiple vaccine and therapeutic candidates for clinical evaluation and future use in preventing or treating Ebola," BARDA Director Robin Robinson said in a statement.
Efforts to boost ZMapp production capacity are underway at the Centers for Innovation in Advanced Development and Manufacturing, which is composed of three separate labs: the Texas A&M Health Science Center in partnership with Britain’s GlaxoSmithKline Plc, Emergent Biosolutions in Maryland, and Novartis AG lab in North Carolina.
The three advanced labs were established by the US government in 2012 with $440 million in seed money, and are required to develop flexible manufacturing capabilities to allow them to produce countermeasures against chemical, biological, and other threats.
Supplies of ZMapp, which was manufactured by San Diego-based Mapp Pharmaceuticals, ran out in August after it was given to two American medical workers who contracted the disease in Liberia – Dr. Kent Brantly and Nancy Writebol. Both of the workers recovered. The drug is a cocktail of antibodies engineered to recognize the virus and bind to infected cells, and is made from genetically modified tobacco plants.
“We look forward to leveraging our manufacturing capabilities to expand production of this experimental therapeutic and to find other ways to support the U.S. government’s fight against Ebola,” said Adam Havey, president of Emergent's biodefense division. He also told Reuters that the company has been in discussions with plant-based manufacturers to develop a response to the task order.
It must be noted, however, that according to the Centers for Disease Control and Prevention (CDC), ZMapp has yet to be tested for safety and effectiveness in humans. Also, ZMapp can’t prevent infection, as it’s a therapeutic drug, not a vaccine for Ebola.
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| Ebola virus emerging from infected cell. |
Rt.com
US officials have asked labs to submit plans for ramping up production of the experimental Ebola drug, Zmapp, of which supplies have run out. It successfully treated medical workers infected with the virus, but hasn't been widely tested for safety.
The US Department of Health and Human Services, through its BARDA division, issued the order for mass producing the antiviral cocktail on Thursday. Three advanced biological laboratories have until November 10 to submit detailed plans with budgets and timetables, according to Reuters.
The US government "is working with partners around the world as quickly as possible to advance the development of multiple vaccine and therapeutic candidates for clinical evaluation and future use in preventing or treating Ebola," BARDA Director Robin Robinson said in a statement.
Efforts to boost ZMapp production capacity are underway at the Centers for Innovation in Advanced Development and Manufacturing, which is composed of three separate labs: the Texas A&M Health Science Center in partnership with Britain’s GlaxoSmithKline Plc, Emergent Biosolutions in Maryland, and Novartis AG lab in North Carolina.
The three advanced labs were established by the US government in 2012 with $440 million in seed money, and are required to develop flexible manufacturing capabilities to allow them to produce countermeasures against chemical, biological, and other threats.
Supplies of ZMapp, which was manufactured by San Diego-based Mapp Pharmaceuticals, ran out in August after it was given to two American medical workers who contracted the disease in Liberia – Dr. Kent Brantly and Nancy Writebol. Both of the workers recovered. The drug is a cocktail of antibodies engineered to recognize the virus and bind to infected cells, and is made from genetically modified tobacco plants.
“We look forward to leveraging our manufacturing capabilities to expand production of this experimental therapeutic and to find other ways to support the U.S. government’s fight against Ebola,” said Adam Havey, president of Emergent's biodefense division. He also told Reuters that the company has been in discussions with plant-based manufacturers to develop a response to the task order.
It must be noted, however, that according to the Centers for Disease Control and Prevention (CDC), ZMapp has yet to be tested for safety and effectiveness in humans. Also, ZMapp can’t prevent infection, as it’s a therapeutic drug, not a vaccine for Ebola.
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