Recombinant Pharmaceuticals Article

Recombinant Pharmaceuticals Article - viewpoint viewpoint...

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viewpoint ©2005 EUROPEAN MOLECULAR BIOLOGY ORGANIZATION EMBO reports VOL 6 | NO 7 | 2005 viewpoint Molecular farming for new drugs and vaccines Current perspectives on the production of pharmaceuticals in transgenic plants The European Union Framework 6 Pharma–Planta Consortium T he first recombinant plant-derived pharmaceutical protein (PDP) was human serum albumin, initially pro- duced in 1990 in transgenic tobacco and potato plants (Sijmons et al , 1990). Fifteen years on, the first technical proteins pro- duced in transgenic plants are on the market, and proof of concept has been established for the production of many therapeutic proteins, including antibodies, blood products, cytokines, growth factors, hormones, recombinant enzymes and human and veterinary vaccines (Twyman et al , 2005). Furthermore, several PDP products for the treatment of human dis- eases are approaching commercialization (Table 1), including recombinant gastric lipase for the treatment of cystic fibrosis, and antibodies for the prevention of dental caries and the treatment of non-Hodgkin’s lymphoma (Ma et al , 2003). There are also several veterinary vaccines in the pipeline; Dow AgroSciences (Indianapolis, IN, USA) announced recently their intention to produce plant-based vaccines for the animal health industry. As molecular farming has come of age, there have been technological develop- ments on many levels, including trans- formation methods, control of gene expression, protein targeting and accu- mulation, the use of different crops as pro- duction platforms (Twyman et al , 2003), and modifications to alter the structural and functional properties of the product. One of the most important driving factors has been yield improvement, as product yield has a significant impact on economic feasibility. Strategies to improve the recombinant protein yield in plants include the development of novel promoters, the improvement of protein stability and accumulation through the use of signals that target the protein to intracellular compartments, and the improvement of downstream processing technologies (Menkhaus et al , 2004). Attention is now shifting from basic research towards commercial exploitation, and molecular farming is reaching the stage at which it could challenge estab- lished production technologies that use bacteria, yeast and cultured mammalian cells. In this review, we highlight not only recent progress in molecular farming and its potential for commercial drug develop- ment and production, but also the regula- tory control, biosafety and political impacts of the technology, and its related intellectual property (IP) issues. 593 Table 1 | Plant-derived pharmaceutical proteins that are closest to commercialization for the treatment of human diseases Product Class Indication Company/Organization Crop Status Various single- Antibody Non-Hodgkin’s Large Scale Biology Corp Viral vectors Phase I chain Fv anti- lymphoma in tobacco body fragments CaroRx Antibody Dental caries
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