Oxford BioMedica, Viragen , and Roslin Institute, announce the successful expression of human interferon alpha-2a in the whites of eggs laid by transgenic hens using the Ova system
This is the third therapeutic protein expressed thus far in a series of proof-of-principle studies, which aim to develop the Ova System as a novel, large-scale biomanufacturing alternative capable of cost-effectively expressing many types of therapeutic proteins.
Viragen holds the worldwide exclusive license to commercialise avian transgenic technology as granted by Roslin Institute.
Alpha interferon is a protein produced by the human immune system that is fundamental to the body's resistance to disease.
This Ova-expression study produced interferon alpha-2a, which is the active ingredient in Roferon-A (Roche), a drug approved for the treatment of certain chronic infectious diseases and cancers.
Importantly, the team has previously demonstrated that the Ova System can repeatedly target expression to the oviduct and incorporation in the egg, rather than being expressed throughout the bird, plus the characteristic of protein drug expression is able to be passed to subsequent generations.
This combination of features is essential for a viable and cost-competitive manufacturing system.
Viragen has previously reported successful Ova-expression of a humanised monoclonal antibody it is developing for advanced malignant melanoma and interferon beta-1a, which is currently marketed under two competing brand names for the treatment of multiple sclerosis (MS), as Avonex (Biogen Idec) and Rebif (Merck Serono).
The project's scientific leader, Helen Sang of Scotland's Roslin Institute, commented: "With each new functional protein that we recover from transgenic hens' eggs, synthesised as a component of the egg white, we significantly advance our collective knowledge and experience.
"We have now demonstrated synthesis of three different proteins at a consistent level and will move on to characterise Ova-expressed interferon alpha to further refine and optimise the technology".
According to vice president and managing director of Viragen (Scotland) Karen Jervis, the Ova System production method differs dramatically from standard interferon manufacturing methods.
"Typically, single-subtype, recombinant alpha interferon is manufactured in bacterial or mammalian cells in bioreactors housed in complex and costly facilities.
"With the Ova System, we expect to offer large-scale manufacturing capabilities in a setting far less capital-intensive and with high levels of efficiency and quality.
"Most importantly, OVA-expressed proteins will need to adhere to extremely stringent quality standards, and we are proceeding with comprehensive internal and external studies to fully characterize the proteins we express through biochemical and functional testing.
"These data, if positive, will be pivotal in preparing both a compelling economical model and a safety/quality case for the regulatory authorities".
"I congratulate the Viragen, Roslin and Oxford BioMedica teams that all played key roles in adding another therapeutic candidate to our portfolio of Ova-expressed proteins," stated Viragen's president and CEO, Charles Rice.
"This alliance continues to pioneer advancements in the field of transgenic hen protein production, and as we gather additional supporting evidence, we will pursue strategies designed to expedite a regulatory pathway for one candidate, which we expect to ultimately lead to key commercial licenses".
Professor Alan Kingsman, Oxford BioMedica's chief executive officer, commented: "The collaboration with Viragen and the Roslin Institute to develop an effective avian transgenic system for biomanufacturing goes from strength to strength.
"This milestone further demonstrates the commercial potential of this technology."
