Oxford BioMedica, Viragen, and the Roslin Institute (Scotland) today announced a breakthrough in their collaborative project to develop avian transgenic biomanufacturing
For the first time, the collaboration has produced a potentially therapeutic protein selectively in the whites of eggs laid by a transgenic hen.
This technology is expected to offer a low cost manufacturing alternative for the production of many protein drugs, with additional potential advantages in the quality of the products.
The therapeutic protein successfully expressed, using Oxford BioMedica's LentiVector gene delivery system in Viragen's proprietary avian system, is a novel structure of an antibody in Viragen's product portfolio, designed to treat malignant melanoma.
Three other protein-drug candidates are included in ongoing avian expression studies to demonstrate the breadth of its capabilities, including two commercially marketed products, both of which realise more than $2 billion in annual sales.
Analysis indicates that the protein expression levels in the egg are significantly higher than any previously published results for a therapeutic protein produced from an avian transgenic line.
The project's scientific leader, Roslin senior scientist, Helen Sang, commented on the breakthrough: "We have long believed that this joint effort would develop an avian system capable of efficiently and economically producing human biopharmaceuticals, and with this major milestone achievement, I am even more convinced that we are developing an elite manufacturing platform that should emerge as a method of choice for many products." Dr Sang elaborated on how this differs from earlier avian results: "We previously published results demonstrating ubiquitous expression throughout the entire bird".
"This latest result indicates that we have now been able to target the expression so that the functional protein is synthesised as a component of the egg white." Viragen's president and CEO, Charles Rice, discussed the market opportunity: "The biopharmaceutical drug market is projected to generate in excess of $50 billion in sales by 2010, and antibodies alone are expected to make up approximately $17 billion of that market".
"Our goal is clear - to develop a manufacturing platform for many of these products that offers compelling advantages over existing systems." Commenting on the milestone achievement, Oxford BioMedica's CEO, professor Alan Kingsman, said: "We are delighted that our collaborative partner Viragen, with the Roslin Institute, is making such rapid progress towards the development of avian-manufactured therapeutic products.
"The milestone reported today represents a major technical achievement in targeted protein production within a transgenic animal and further demonstrates the value of the LentiVector system in providing long-term, stable gene expression that is amenable to tissue-specific regulation.
"Viragen's achievement, together with today's announcement of preclinical efficacy data with Innurex, Oxford BioMedica's LentiVector-based product for nerve repair, emphasise the progress being made and the versatility of this exceptional gene transfer technology".
