The experimental Ebola drug used on two health workers who recovered has garnered some attention because it is manufactured from cells grown in tobacco leaves. But with Ebola rampaging through West Africa and now having reached the U.S., its maker and U.S. officials want to expand its current production while also seeing if traditional mammalian-cell methods might be used to quickly scale up production of the drug, ZMapp.
The Department of Health and Human Services (HHS) is in talks with manufacturer Caliber Biotherapeutics to see if it could do more tobacco-based production, The New York Times reports, while the Bill & Melinda Gates Foundation is in talks with Amgen ($AMGN) to see if a more traditional approach could be used. Creating an animal-derived formulation of ZMapp might take months, however, putting off a manufacturing scale-up until next year.
The drug's originator, San Diego, CA-based Mapp Biopharmaceutical, told Reuters on Friday that it was now manufacturing the drug using traditional methods of cultivating the antibodies from mammalian cells in stainless steel vats.
"While offering a slower route than plant production, the infrastructure for manufacturing in CHO (Chinese hamster ovary) cells is well established, which means the potential scale of drug production is greater than the production capacity of existing PMP (plant-made pharmaceutical) facilities," the company told Reuters in a statement.
An official with the Bill & Melinda Gates Foundation told Bloomberg that initial discussions have been held with Amgen to see if the biotech company might be able to hasten production. "No final decision has been made on the pharma partner," Bryan Callahan, a senior program officer at the foundation, told Bloomberg in an email. The foundation gave Mapp a $150,000 grant to investigate the feasibility of a new large-scale production technique.
The drug is a cocktail of three antibodies. Besides the U.S. health workers, it was used to treat a Spanish priest, who died, and three Liberian health workers. But the company has exhausted the small supply it had on hand while it developed the unapproved drug.
The current process, being done in a tobacco plant in Kentucky, is to fuse genes for the desired antibodies to genes for a natural tobacco virus. The tobacco plants are infected with the artificial virus, producing the antibodies, and then the plants are ground up and the antibodies extracted, Bloomberg explained. A spokesperson for Kentucky BioProcessing, the unit of Reynolds American making the drug, said the unit is now focused entirely on manufacturing more of the drug.
Texas A&M Center for Innovation in Advanced Development & Manufacturing is also having discussions with HHS about producing the drug, Bloomberg said. It is partnered with Caliber, which has estimated it could produce up to 100 kilograms of the ZMapp antibody per year, perhaps enough to treat 20,000 patients.