MOLECULAR FARMING

One of the current major challenges is the provision of safe, efficacious and affordable pharmaceuticals on a global level for the treatment and prevention of disease. It is also very important to provide Europe with a competitive platform to strengthen the European pharmaceutical sector. A crucial question is how medicines for major largely ignored diseases, including emerging diseases, can be made affordable and in sufficiently large volumes and how they can be supplied to low-income populations.

The global pharmaceutical industry is a multibillion dollar business (about USD 500 billion) growing at 10% per year. The final drug products consist of one or more active pharmaceutical ingredients (APIs). The APIs manufactured by chemical synthesis and biotransformation are typically small molecules, whereas APIs manufactured by fermentation or cell culture can either be small molecules (secondary metabolites) or biological molecules (i.e. proteins). Recombinant pharmaceuticals are the fastest growing class of novel medicine with monoclonal antibodies,cytokines and blood products as major drivers. At the moment they represent approximately 30% of all marketed drugs in the US and EU. Many of these novel protein and peptide drugs cannot be produced by classical chemistry or microbial fermentation.

Molecular Farming (MF) in plants or plant cell cultures offers a viable alternative technology that has great potential to fulfill requirements specific for the production of complex recombinant proteins, including pharmaceuticals and other commercially valuable target proteins like diagnostics, veterinary vaccines and industrial proteins. The first recombinant plant-derived vaccine for veterinary use was licensed in 2006, and several plant-produced pharmaceuticals are now in clinical trials and approaching commercial release within the next few years, mostly in the US. However, there are still many issues that need to be addressed by the scientific and regulatory communities, e.g. technical and manufacturing issues; regulatory, intellectual property (IP) and technology transfer aspects; and the co-development of MF in developing countries. In Europe, an equally important aspect is the establishment of a coherent strategy for the development of MF that encompasses the reconciliation of scientific, political and public engagement. This Action provides the ideal and most cost-effective forum for this purpose, as it leverages and benefits from a sustained and continuous investment through FPs 4-6, national and industrial funding. The EU is expected to continue funding MF related research with increased vigour through FP7. The Action will bring much-needed coordination and interaction among scientists with expertise/funded activities and scientists who are just initiating programs in MF. Therefore this COST Action provides the best forum for these activities involving the majority of European countries. Importantly, it will allow the participation of states from Eastern Europe, who have generated considerable expertise in the field, but have had limited opportunities to work together with their colleagues from Western Europe.