“All of our focus is solely on ZMapp production. We’re hoping our efforts can help expedite the drug approval process,” David Howard, spokesman for Reynolds American, the tobacco company that owns the facility that makes pharmaceuticals from tobacco, told Patton. The genetic makeup of tobacco makes it an easy vehicle for genetic engineering.
The drug has been sent to government agencies for testing, but it hasn’t been used on any more patients since the two Americans, Dr. Kent Brantly and Nancy Writebol, who have since recovered, were given the drug, Patton writes. She also noted that “it’s uncertain whether the ZMapp helped cure Brantly or Writebol,” but the drug has shown “promising results in testing in primates and mice, curing most of them even after they showed signs of infection.”
ZMapp is “a cocktail of antibodies that has been proven to be the most effective treatment so far in fighting off the Ebola virus,” Patton writes in a separate article. It was developed while working under contract for the U.S. Department of Defense and other federal agencies to be a “post-exposure treatment for Ebola virus.”
The process involves growing a unique tobacco plant and “infecting” the plant with a protein that will “battle the Ebola.” The protein then reproduces inside the tobacco plant “like a photocopier.” And when ready, the desired proteins are extracted from the plants and put into a serum, Patton reports.
According to the website of Mapp Biopharmaceutical, a company that collaborates with Kentucky BioProcessing, the supply of ZMapp was used up in August, Patton reports.
In September, the federal government announced that it had given Mapp an 18-month contract for as much as $42.3 million for “the development and manufacturing of the medication ZMapp toward the goal of U.S. Food and Drug Administration approval,” Patton reports.
Mapp says it is is conducting studies that will help determine the safety and efficacy of the drug while improving its manufacturing process, increasing yields and scale.
“The Department of Health and Human Services is also in advanced discussions to enlist Caliber Biotherapeutics, a Texas company that can produce the drug in millions of tobacco plants,” according to federal officials and pharmaceutical industry executives, Andrew Pollack reports for The New York Times.
He reports that federal officials along with two of the world’s biggest charities are also looking at arranging for production of ZMapp in animal cells, a more conventional method that takes longer, but allows for for greater output.
But even if these new contracts are negotiated, Pollack reports that there will only be “hundreds or thousands of treatment courses by early next year, which would not be nearly enough if the epidemic continues to spiral out of control.”