The Texas A&M Health Science Center is one of the three sites on standby for mass production of Z-MAPP, an investigational drug for Ebola awaiting approval from the U.S. Food and Drug Administration (FDA).
Z-MAPP is an antibody cocktail developed by Mapp Biopharmaceuticals against Ebola virus. “It is very specific for Ebola and it has shown very promising data in pre-clinical studies,” comments Dr. Gerald Parker with the Texas A&M Health Science Center. However, as Z-MAPP is still to yet receive approval, it can only be administered to a patient under strict guidelines by the regulatory agency.
The Texas A&M facility is one of the three advanced labs in the U.S. dedicated to scaling up any compound critical to stem a fatal disease outbreak, such as Ebola virus. The other two facilities are located in Maryland and North Carolina. The Texas site particularly complements Mapp Biopharmaceutical’s Z-MAPP as it is the only one among the three equipped with plant-based systems for production of antibodies. The site is also fitted out with a dozen bus-length mobile sterile rooms that can mass produce vaccines as needed. The site makes use of technologies, including Eppendorf’s scalable systems, to quickly produce vaccines and drugs.
“We are moving forward and the whole community is moving forward as we better understand the efficacy going ahead and starting production of it as well, we can't afford to wait… Once given the go ahead, it's going to be weeks to months as opposed to months and years,” said Parker. He adds that the innovation has the potential to help save many lives in danger of the disease.
The Texas A&M lab is currently working in collaboration with GlaxoSmithKline, which is also conducting a Phase 1 trial for a vaccine against the deadly disease. Along with NewLink Genetics, GSK hopes to release the vaccines on an emergency basis following the studies’ completion. NewLink has also received the go-ahead from the FDA regarding its own Phase 1 trial for an investigational Ebola vaccine. The two companies hope to bring the vaccines only by 2015.