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By Sharon Begley and Toni Clarke
NEW YORK/WASHINGTON, Aug 9 (Reuters) - All three U.S.facilities established to quickly make vaccines and therapeuticsin the event of a major public health threat say they arestanding by to support any U.S. government effort to scale up atreatment for Ebola.
The facilities, called Centers for Innovation in AdvancedDevelopment and Manufacturing (ADM), were set up by the U.S.Department of Health and Human Services in partnership withprivate industry, to respond to pandemics or chemical,biological, radiological, or nuclear threats.
They have the expertise to quickly switch production linesto manufacture, for example, a smallpox vaccine if that scourgewere to re-emerge, or an anthrax vaccine, and other life-savingcompounds 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 ScienceCenter, site of one of the facilities. "We are prepared."
Global health agencies are only starting to consider whetherto make experimental drugs, most of which have only been testedon monkeys, available to patients in West Africa, which issuffering the worst Ebola outbreak in history.
The World Health Organization is convening a group ofbioethicists to consider such as issues as who decides whichpatients would receive the treatments or vaccines. U.S.officials have repeatedly emphasized the importance of publichealth measures such as quarantines to stop the spread of thedisease.
Among the Ebola treatments that have shown promising resultsin lab animals is an antibody cocktail from MappBiopharmaceutical, a tiny biotechnology company in San Diego; avaccine from Profectus in Tarrytown, New York; and anRNA-interference drug being developed by Vancouver-based,Tekmira Pharmaceuticals, which late last week gotapproval from the U.S. Food and Drug Administration to resumesafety trials in human volunteers.
The decision to order any of the three advanced labs tobegin making Ebola treatments would be made at the highestlevels of the Obama administration.
BUS-LENGTH CLEAN ROOMS
The Texas facility consists of a dozen bus-length mobileclean rooms, each supplied with sterile air, nutrient media forgrowing 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 newervarieties grown in mammalian or bacterial cells. "The whole ideais to take a process that may exist only on sticky notes at asmall biotech company and scale it up as fast as possible"
The three centers are required to have the ability toproduce vaccines against pandemic flu but must also dedicate atleast six months a year to developing products against otherthreats, and at sufficient volume to meet a sudden spike in U.S.demand, Giroir said.
The Texas facility collaborates with British drugmakerGlaxoSmithKline Plc. A center led by EmergentBiosolutions in Baltimore, Maryland, collaborates with variousuniversities as does the third center, in Holly Springs, NorthCarolina, led by Swiss drug company Novartis AG.
Their operations are funded with $400 million from HHS andare overseen by the Biomedical Advanced Research and DevelopmentAuthority (BARDA), part of HHS's Office of the AssistantSecretary for Preparedness and Response.
Combined, the centers have the capacity to produce anddeliver at least 50 million doses of vaccine against pandemicinfluenza, the most likely source of a health emergency, within12 weeks.
Any Ebola order would be for much fewer doses, said Giroir."Even if Ebola were spreading here, it's not an airbornetransmissible disease like influenza so you wouldn't need 50million doses. At most you'd need a few thousand, maybe amillion."
SCALING UP
The centers are not set up to invent drugs. They aredesigned to take what Giroir calls "the scientific substrate" orrecipe for the product, either an existing one or, as in thecase of Ebola treatments, an experimental one and develop aprocess for making it.
Of the three, only the Texas lab said it can produceproteins such as human antibodies in plant-based systems, whichis how Mapp's Ebola drug has been made in limited quantities, sothe government may sub-contract with a company that hasadditional plant technology.
One candidate is Bryan, Texas-based Caliber BiotherapeuticsLLC. Mapp currently works with Kentucky BioProcessing, a unit oftobacco giant Reynolds American to produce its drug.More capacity would be needed to scale up.
Emergent Biosolutions' facility does not have the recipe todevelop an Ebola treatment, but Adam Havey, president of thecompany's biodefense division, said that if the government askedit to produce something against the virus "we would absolutelyrespond to that."
Novartis said its facility also "stands ready, as withprevious public health emergencies, to provide scientificsupport aimed at halting the current outbreak."
Even with dedicated facilities to hand, getting medicines toAfrica quickly and in sufficient quantities will be a challenge.
BARDA does have a network of distributors, including BaxterInternational Inc, Cook Pharmica LLC and JHPPharmaceuticals, who would be obliged, if requested, to fillvials and package a BARDA-designated product.
While U.S. legislation intended such production to be forU.S. use, there are provisions for products to be provided toallies and other countries if it is in the interest of nationalsecurity. (Reporting by Sharon Begley and Toni Clarke; Editing by MicheleGershberg and Martin Howell)
