Kentucky BioProcessing, the Owensboro company that grew the ZMapp compound given to two American Ebola survivors, has gone into full-scale production of the drug.
The plant has put all other projects on hold, said David Howard, spokesman for Reynolds American, which owns the contract production facility that grows pharmaceuticals in a special kind of tobacco plant.
"All of our focus is solely on ZMapp production," Howard said Tuesday.
Kentucky BioProcessing reconfigured its production plans in early August, he said, and it now has more of the ZMapp compound grown for Mapp Biopharmaceutical.
"We're hoping our efforts can help expedite the drug approval process," Howard said.
Quantities have been sent to government agencies for testing, but so far, no more ZMapp has been requested to treat individual patients infected with the deadly virus that has killed more than 4,000 people, including one man in Texas.
Two Americans, Dr. Kent Brantly and Nancy Writebol, recovered from Ebola after being given the ZMapp drug.
Brantly has donated blood to help Nina Pham, a nurse in Texas who contracted the disease after treating Liberian victim Thomas Eric Duncan, who died Oct. 8 in Dallas.
According to Mapp Biopharmaceutical's website, the existing supply of ZMapp was used up in August. Representatives of the company did not respond to calls for comment.
"August 12, 2014 at 8:30 AM — The available supply of ZMapp has been exhausted. We have complied with every request for ZMapp that had the necessary legal/regulatory authorization," a statement on the website said. "It is the requestors' decision whether they wish to make public their request, acquisition or use of the experimental drug. Any decision to use ZMapp must be made by the patients' medical team. Drug has been provided at no cost in all cases."
It's uncertain whether the ZMapp helped cure Brantly or Writebol, who were among the first humans to receive it. But it has shown promising results in testing in primates and mice, curing most of them even after they showed signs of infection.
In September, Health and Human Services announced that it had issued an 18-month contract with Mapp Biopharmaceutical 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."
"While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy," Dr. Nicole Lurie, assistant secretary for preparedness and response, said in a news release. "Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today's agreement represents an important step forward."
As part of the project, Mapp Biopharmaceutical is manufacturing a small amount of the drug for early-stage clinical safety studies and non-clinical studies needed to demonstrate the drug's safety and efficacy in people. Mapp Biopharmaceuticals also will work with the government on the manufacturing process, increasing production yields and the scale of manufacturing.
It takes several weeks to make the compound, which includes three monoclonal antibodies, which is then put into the tobacco plants to replicate, Howard said Tuesday.
"The plants have to grow, then the proteins are extracted and purified," Howard said. "It potentially takes two months or a little longer to produce."
Kentucky BioProcessing has hired more people and has filled its 32,000-square-foot manufacturing plant with tobacco plants growing ZMapp, he said.
"Right now, that's our sole focus," Howard said. "We would expect to do it as long as it takes."