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YourHealth, World

Sunday, Aug 10, 2014

YourHealth, World

US emergency labs ready to work on Ebola drugs if asked

Reuters | Sunday, Aug 10, 2014

NEW YORK/WASHINGTON - All three US facilities established to quickly make vaccines and therapeutics in the event of a major public health threat say they are standing by to support any US government effort to scale up a treatment for Ebola.

The facilities, called Centers for Innovation in Advanced Development and Manufacturing (ADM), were set up by the US Department of Health and Human Services in partnership with private industry, to respond to pandemics or chemical, biological, radiological, or nuclear threats.

They have the expertise to quickly switch production lines to manufacture, for example, a smallpox vaccine if that scourge were to re-emerge, or an anthrax vaccine, and other life-saving compounds against both natural outbreaks and bioterrorism.

"They know our number and they can call us 24 hours a day,"said Brett Giroir, chief executive of Texas A&M Health Science Center, site of one of the facilities. "We are prepared."

Global health agencies are only starting to consider whether to make experimental drugs, most of which have only been tested on monkeys, available to patients in West Africa, which is suffering the worst Ebola outbreak in history.

The World Health Organization is convening a group of bioethicists to consider such as issues as who decides which patients would receive the treatments or vaccines. US officials have repeatedly emphasised the importance of public health measures such as quarantines to stop the spread of the disease.

Among the Ebola treatments that have shown promising results in lab animals is an antibody cocktail from Mapp Biopharmaceutical, a tiny biotechnology company in San Diego; a vaccine from Profectus in Tarrytown, New York; and an RNA-interference drug being developed by Vancouver-based, Tekmira Pharmaceuticals, which late last week got approval from the US Food and Drug Administration to resume safety trials in human volunteers.

The decision to order any of the three advanced labs to begin making Ebola treatments would be made at the highest levels of the Obama administration.

BUS-LENGTH CLEAN ROOMS

The Texas facility consists of a dozen bus-length mobile clean rooms, each supplied with sterile air, nutrient media for growing cells, and other clean-manufacturing requirements.

"We are prepared to make any kind of vaccine," Giroir said, from the traditional kind grown in chicken eggs to newer varieties grown in mammalian or bacterial cells. "The whole idea is to take a process that may exist only on sticky notes at a small biotech company and scale it up as fast as possible."

The three centres are required to have the ability to produce vaccines against pandemic flu but must also dedicate at least six months a year to developing products against other threats, and at sufficient volume to meet a sudden spike in US demand, Giroir said.

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