Viragen, Oxford BioMedica report breakthrough in biomanufacturing project

This technology is expected to offer a lower-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, is a novel structure of an antibody in Viragen’s product portfolio being designed to target 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, each of which realizes more than $2 billion in annual sales.

Viragen and Roslin confirmed qualitative and quantitative detection, and recovery of humanized antibody from the eggs. The analysis indicates that the expression levels measured 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 Dr Helen Sang, lauded 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.”

Discussing the market opportunity, Viragen president and CEO Charles Rice added, “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.”