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PostPosted: Thu Sep 04, 2014 5:53 am 
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Media reports cite the possible availability of 200 doses of ZMapp by the end of 2014.

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PostPosted: Thu Sep 04, 2014 5:56 am 
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In at least one case, events have overtaken the planning efforts.

While the experts worked at devising ethics-based options for who should have access to limited supplies of vaccines and drugs, all available supplies of one drug – ZMapp – were snapped up.

There were fewer than a dozen treatment courses of the drug – a cocktail of antibodies devised by scientists at Canada’s National Microbiology Laboratory in Winnipeg – in existence when the epidemic broke out. They had been made, at considerable expense, for research purposes. And some of these treatment courses were used in animal studies.

(A study published last week showed the antibodies saved 18 monkeys infected with what should have been a lethal dose of Ebola, even though in some cases treatment was only started at Day 5, when the animals had progressed to severe disease.)

Then in late June two infected American missionaries became the first people treated with ZMapp, initially sharing a single dose. Both survived, with one, Dr. Kent Brantly, reportedly making a surprisingly speedy recovery.

In short order Spain acquired ZMapp for an infected Spanish priest; he died after getting only a single dose of the three-dose treatment course. Britain secured the two remaining doses of that treatment course for a nurse infected in Sierra Leone; he left hospital earlier this week.

Liberia asked the U.S. government for ZMapp for three infected health-care workers; one died, but two have recovered. And that was it for ZMapp, at least until more can be made.

There are hopes, Kieny said, that if production can be ramped up that perhaps 200 doses of the drug could be available by the end of the year.

http://globalnews.ca/news/1542972/exper ... -vaccines/

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PostPosted: Thu Sep 04, 2014 6:19 am 
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What's different about ZMapp is the way cloned cells _ called monoclonal antibodies _ are made. Instead of being incubated in the cells of mice, rats or Chinese hamsters, the antibodies at the heart of ZMapp are grown in tobacco plants.

After scientists identify and design the specific cocktail of antibodies that will beckon the immune system's defenses, they genetically engineer a plant virus to ferry them into the plants. (Plant viruses are not dangerous to people.) The infected plants are grown in windowless hydroponic warehouses under artificial lights. There's no dirt, which might contain contaminants, just water and plastic mesh, and a conveyor system that ferries the plants around so they get the optimal amount of light.

The tobacco plants incubate the virus and its cloned antibody cargo. But in seven to 10 days, the virus kills the plant, turning it yellow and causing it to wilt. The dying plants are harvested and ground into a green sludge. After the proteins in the mixture are distilled and purified, the result is a vial of colorless liquid.

To produce the 10 grams of antibodies needed for a single course of ZMapp, Mapp Biopharmaceutical currently requires 30 to 50 kilograms of tobacco leaves _ the capacity of a small greenhouse. If tobacco plants could be engineered to produce antibodies more efficiently, that volume could be reduced to about 10 kilograms, said Charles Arntzen, an Arizona State University microbiologist who pioneered the process by which "plantibodies" are made.

Now that the key antibodies have been identified _ a project Mapp Bio scientists worked on for years _ it takes four to six months to produce a clinical-grade medicine. That's a land speed record compared with the 12-to-20-month process used in making biologic drugs the conventional way, said Dr. Michael Kurilla, director of the Office of Biodefense Research Resources and Translational Research at the National Institute of Allergy and Infectious Diseases.

Another key roadblock is the novelty of the ZMapp production process. The Food and Drug Administration has yet to draft the quality-control strictures that would govern the large-scale production of plantibodies.

To date, the FDA has approved only one other biologic therapy that uses a similar process: In 2012, the Israeli company Protalix Biotherapeutics won the agency's blessing to sell a drug for Gaucher's disease that is manufactured in carrot cells.

"I'm sure the FDA has tools to evaluate each technology on its own," said David Aviezer, chief executive of Protalix. But the relative novelty of ZMapp's production process adds "another step" that could create delays in getting ZMapp to the epidemic's front lines, he said.

Under the new federal contract, Mapp Bio will make "a small amount of the drug" for use in human safety trials, according to the Department of Health and Human Services. Government officials, company scientists and independent experts will also explore ways to ramp up production and speed the development of regulations to ensure the drug can be made in large quantities.

Dr. Robin Robinson, director of the department's Biomedical Advanced Research and Development Authority, said the first lot of ZMapp "is now under production." That lot will be used in human trials scheduled to begin at the end of 2014 and to conduct additional animal studies of its safety and effectiveness, he said.

Ultimately, ZMapp could be made somewhere in Africa, and South African officials are in talks with U.S. officials and Mapp Bio to develop a production facility there, according to Ed Rybicki, director of the University of Cape Town's Biopharming Research Unit.

"We most certainly have the expertise and the necessary infrastructure to support a facility," Rybicki said. "Trouble is, it needs to be built."

http://hdnews.net/news/nationworld/U-S- ... -drug-work

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PostPosted: Thu Sep 04, 2014 6:57 am 
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Ebola outbreak: Experts meet to advise WHO on how to use experimental drugs
Meeting follows earlier consultation about whether ethical to use unlicensed Ebola drugs in outbraek
The Canadian Press Posted: Sep 04, 2014 5:48 AM ET Last Updated: Sep 04, 2014 5:54 AM ET
Image
Marie Paule Kieny, assistant Director-General of the World Health Organization, said the international meeting is about making a plan of how experts could accelerate compassionate use of the most promising Ebola vaccines. (Denis Balibouse/Reuters)

There are hopes, Kieny said, that if production can be ramped up that perhaps 200 doses of the drug could be available by the end of the year.

http://www.cbc.ca/news/health/ebola-out ... -1.2755217

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PostPosted: Thu Sep 04, 2014 10:00 am 
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A very limited supply (fewer than 10 treatment courses) has been deployed to the field. Efforts to scale up production may yield increased supplies of potentially few hundred doses by the end of 2014 (page 6 at link below)

http://www.who.int/csr/disease/ebola/eb ... 4.pdf?ua=1

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