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Kentucky Bioprocessing in Owensboro, Kentucky, Producing Delivery Of Breakthrough Ebola Vaccine

A breakthrough therapy in the fight against the deadly Ebola virus is being produced by Kentucky Bioprocessing in Owensboro, Kentucky.

The Defense Advanced Research Projects Agency said Kentucky Bioprocessing was awarded an agreement to develop a platform capable of delivering vaccine grade recombinant proteins that could be used to produce the Ebola along with other vaccines.

The Kentucky firm was contracted by California based Mapp Biopharmaceutical to produce ZMapp, the San Diego firm’s breakthrough drug in the fight against Ebola. Kentucky Bioprocessing’s compound is an essential component in the production and delivery of future vaccines, such as ZMapp, a medical advance under study in the fight against the Ebola virus.

Kentucky BioProcessing’s platform is a plant-based system that uses non-genetically modified tobacco plants as a host for the expression of vaccine grade recombinant protein. The system is adaptable to producing recombinant proteins against pathogens such as the deadly Ebola virus.

James Pettitt of the U.S. Army Medical Research Institute of Infectious Diseases, said the research team previously demonstrated that the treatment—known as MB-003—protected 100 percent of non-human primates when given one hour after Ebola exposure. Two-thirds of the animals were protected when treated 48 hours after exposure.

Ebola virus has been responsible for numerous deaths in Africa over the past several years. In addition to being a global health concern, the virus also is considered a potential biological threat agent.

“By requiring both a documentable fever and a positive diagnostic assay result for Ebola infection before initiating treatment in these animals, we were able to use MB-003 as a true therapeutic countermeasure,” said senior author Gene Olinger, Ph.D., of USAMRIID. “These initial results push the threshold of MB-003 from post-exposure prophylaxis to treating verified illness.”

According to the scientists, Ebola virus replicates quickly to very high levels, thus overwhelming the host’s ability to fight off the infection. MB-003 is a “cocktail” of monoclonal antibodies that help bind to and inactivate the virus. In addition, said Pettitt, the antibodies recognize infected cells and trigger the immune system to kill them off. No side effects of the antibodies were observed in the surviving animals.

MB-003 was developed through a decade-long collaborative effort between private industry and the U.S. government, with funding from the Defense Advanced Research Projects Agency, the National Institutes of Health, and the Defense Threat Reduction Agency.

“With no vaccines or therapeutics currently licensed to treat or prevent Ebola virus, MB-003 is a promising candidate for continued development,” said collaborator Larry Zeitlin, Ph.D., president of Mapp Biopharmaceutical in San Diego, California.

MB-003 is manufactured in a plant-based system by Kentucky BioProcessing. According to Barry Bratcher, the company’s COO, the plant-based system allows for considerable efficacy while KBP’s automated facility keeps MB-003 cost-effective and cuts down on the production time required.

“Our facility can produce these proteins in two weeks at a substantial reduction in cost to other production methods,” said Bratcher. “This advanced method of manufacturing allows us to address needs quickly and inexpensively.”

Zeitlin said Mapp recently announced formation of a joint venture between LeafBio, Mapp’s commercialization arm and Defyrus of Toronto, Canada, to consolidate their antibody programs. He said the relationship will streamline development of the most potent anti-filovirus products.

US Health and Human Services awarded an 18-month contract to Mapp Biopharmaceutical for up to $42.3 million for "the development and manufacturing of the medication ZMapp toward the goal of U.S. Food and Drug Administration approval."

According to Zeitlin, the next step in the drug development process would be to more extensively test the safety of the antibodies in animals. Once that is established, the safety of the antibodies would need to be assessed in human volunteers. Ultimately, a large efficacy study in non-human primates and a larger safety study in humans would be required for Food and Drug Administration licensure of the product.

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