Viragen, Roslin Institute, and Oxford Biomedica report a breakthrough in the development of the OVA™ System, resulting in a more efficient biomanufacturing platform for the cost-effective production of human therapeutic proteins. The OVA System is Viragen's avian transgenic technology.
Viragen reported that its researchers in Scotland and collaborators at Roslin Institute were able to significantly increase expression levels of interferon alpha-2a by at least 10-fold over previously reported results. Additional protein drug candidates will be evaluated in confirmatory studies.
"Our initial studies producing interferon alpha yielded an expression level of approximately 4 milligrams in each egg,” says Elizabeth Elliot, senior project leader at Viragen Scotland. “But, when we used the new modified regulatory sequence, we expressed up to 40 milligrams per egg. Based on these expression levels, each egg contains enough alpha interferon to treat up to 15 patients suffering from hepatitis C for a full year, which our estimates indicate could be produced at a substantial discount to the cost compared to traditional recombinant systems.
"This achievement may be the catalyst to establish the OVA System as the leading transgenic manufacturing system for difficult-to-manufacture proteins that can be enormously expensive to produce," states Karen Jervis, managing director of Viragen. "We first reported the expression of interferon alpha in the OVA System back in January but we have now further optimized the efficiency of the process by using a modified proprietary regulatory sequence, resulting in a 10-fold increase over previous expression levels. We have every reason to believe these results will translate to other high-value therapeutic proteins that we aim to express using the OVA System."