Bio-Sourcing, through its technology license from LFB, has adapted conventional recombinant DNA technology by incorporating the species-specific gene coding for the biological drug of interest and directing its expression in the mammary glands of rabbits, goats or cows.
Once pilot scale for the production of study material has been established, both upstream (milk production) and downstream (product purification) processes are readily scalable to deliver the commercial product with high yield.
Using farm animals for drug production has many advantages because they are reproducible, have flexible production and are easily maintained. They also have a great delivery method: just milk them.
This has to be one of the best ways to recover large quantities of a protein. Importantly, the mammary glands and milk are not part of the animal’s main life support systems, and there is little risk of harm to the animals involved.
Our goal is to make the upstream process highly simplified compared to other currently available methods hence drastically reducing associated costs. The downstream process follows the conventional route of chromatography, viral inactivation, nanofiltration, fill and finish steps that comply with regulatory GMP-guidelines and are suitable for large-scale production of the highest quality pharmaceutical products.
The FDA and the EMA approved biologics produced in the milk of animals as human therapeutics in 2006 and 2009, respectively, clearing the way for a predictable marketing authorization path in veterinary medicine.
Bio-Sourcing is now partnering with major animal health companies and veterinary medicine academic centers who share the vision of adapting human therapeutic solutions for the production of affordable animal biological drugs. By helping to produce healthier animals, Bio-Sourcing aims to contribute to sustainable development and to the WHO concept “One World, One Health”.