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New method sought to ramp up Ebola drug production.

Byline: Robert Langreth and Makiko Kitamura

Biotechnology researchers and U.S. officials are rushing to try to make more of what may be the most promising experimental drug to treat Ebola after supply ran out in August.

The drug, ZMapp, is made by Mapp Biopharmaceutical Inc. Mapp and its partners have had early discussions with Amgen Inc. about the feasibility of increasing production of the antibody cocktail using a traditional biotechnology manufacturing technique, said Bryan Callahan, a senior program officer with the Bill & Melinda Gates Foundation.

The foundation gave Mapp a $150,000 grant to look at whether a new large-scale production technique is possible. "No final decision has been made on the pharma partner,'' Callahan said in an email. Amgen, based in Thousand Oaks, California, is the world's biggest biotechnology company by sales.

Tobacco plants

ZMapp is made using tobacco plants, which can be induced to grow the antibodies in the drug. Federal officials have also considered an expanded tobacco-based production process.

The cocktail of three antibodies has been used to treat two Ebola-infected American health workers who recovered, a Spanish priest who died, and three Liberian health workers.

Mapp, a closely held, San Diego-based company, developed ZMapp with the Public Health Agency of Canada and the U.S. government. For now, production has been limited to a handful of doses. That's far too few to have an impact on the outbreak in West Africa that, according to the World Health Organization, has infected more than 8,000 people, killing about half.

To produce therapeutic proteins inside a tobacco plant, genes for the desired antibodies are fused to genes for a natural tobacco virus. The tobacco plants are then infected with the artificial virus, producing the antibodies. The plants are then ground up and the antibodies extracted.

The Seattle-based Gates Foundation said Friday its $150,000 grant would look at the possibility of using Chinese hamster ovary cells, similar to how many other complex biotechnology drugs are made, Callahan said. While the technique "offers a slower route than plant production, the infrastructure for manufacturing in CHO cells is well established, which means that production can be scaled up rapidly,'' he said.

The Texas A&M Center for Innovation in Advanced Development & Manufacturing is in daily talks with the U.S. Department of Health and Human Services about how it and its partner, Caliber Biotherapeutics LLC, can product large quantities of ZMapp from tobacco plants, a Texas A&M official said.

The Caliber facility could produce 25 kilograms to 75 kilograms of ZMapp antibody per year, based on preliminary estimates, starting within weeks to months of an order from the U.S., Giroir said. The production facility and its capabilities were created in a joint effort between Texas A&M and Caliber, he said.

Difficult to make

ZMapp is difficult to make in large quantities for a number of reasons, researchers said. It involves three antibodies, which triples the amount of tobacco plants needed. In addition, the dose used to treat patients is high compared with many drugs, increasing the needed supply.

How long it will take to develop an efficient production system "is unpredictable,'' said Charles Arntzen, a plant biotechnology expert at Arizona State University. "This is a biological challenge and we are developing the rules and processes as we go along.''

Robert Kay, CEO of iBio Inc., a Newark, Delaware-based biotechnology company that owns one of the technologies used to make drugs in tobacco plants., estimates the production capacity of Caliber is about 100 kilograms of ZMapp per year, which he said could yield enough to treat 20,000 patients with the drug cocktail.

Kentucky Production

The original supply of ZMapp drug was produced in tobacco leaves at a plant biotechnology facility, Kentucky BioProcessing LLC, a unit of Reynolds American Inc.

Kentucky BioProcessing has "completely rebooted'' its production plans to focus exclusively on making more ZMapp, said David Howard, a spokesman for Kentucky BioProcessing at parent company Reynolds American Inc.

Ebola is normally treated by keeping patients hydrated, and using antibiotics to fight off opportunistic infections.
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Author:Langreth, Robert; Kitamura, Makiko
Publication:Telegram & Gazette (Worcester, MA)
Date:Oct 11, 2014
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