Copyright ©2009 by
P. Soudek
Contents:
Supported by:
Laboratory of Plant Biotechnologies
Hosted by:
Institute of Experimental Botany AS CR
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General background
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. |