Facing the Future with Pharmaceuticals from Plants
Plants are the ultimate source of many of today’s pharmaceutical compounds, but most of our protein drugs are derived from animal sources, and are produced either in cultured animal cells or microbes. The biopharmaceutical industry has developed with mammalian cells treated as the gold standard for production, hence the regulations governing biopharmaceutical production have been tailored for these systems.biopharmaceutical production, despite their many potential advantages which include the prospect of inexpensive, large-scale biopharmaceutical production without sacrificing product quality or safety. The first plant-derived pharmaceutical products have now been approved but these represent a tiny proportion of the products in development, products which could have a profound impact on the cost and availability of medicines to those most in need. In this review, we summarize the state-of-the-art in plant-based production systems and discus the development issues which remain to be addressed before plants become an acceptable mainstream production technology.
KeywordsPlant Cell Culture Transgenic Potato Recombinant Antibody Glycan Structure Curr Opin Plant Biol
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- CPMP (2002) Points to consider on quality aspects of medicinal products contain-ing active substances produced by stable transgene expression in higher plants (CPMP/BWP/764/02). The European Agency for the Evaluation of Medicinal Products (EMEA).Google Scholar
- Drossard J (2003) Downstream processing of plant-derived recombinant therapeutic proteins. In: Fischer R, Schillberg S (eds) Molecular Farming Plant-made Pharmaceuticals and Technical Proteins. John Wiley & Sons Inc., NY, pp. 217-231.Google Scholar
- FDA (2002) Guidance for industry. Drugs, biologics, and medical devices derived from bioengineered plants for use in humans and animals. Food and Drug Administration.Google Scholar
- Gottschalk U (2006) Downstream processing in biomanufacturing: Removing economic and technical bottlenecks. Bioforum Europe 10: 28-31.Google Scholar
- Ma JKC, Barros E, Bock R, Christou P, Dale PJ, Dix PJ, Fischer R, Irwin J, Mahoney R, Pezzotti M, Schillberg S, Sparrow P, Stoger E, Twyman RM (2005a) Molecular farming for new drugs and vaccines. Current perspectives on the production of pharmaceuticals in transgenic plants. EMBO Reports 6: 593-599.CrossRefPubMedGoogle Scholar
- Mora J, Sinclair A, Delmdahl N, Gottschalk U (2006) Disposable membrane chromatography. Performance analysis and economic cost model. BioProcess Int (suppl): 2-6.Google Scholar
- SemBioSys (2006) SemBioSys achieves major insulin milestone. http://www.investor look.com/adminv2/downloads/119/07.17.06%20Insulin%20Accumulation%20 `final.pdf.
- Triguero A, Cabrera G, Cremata JA, Yuen CT, Wheeler J, Ramírez NI (2005) Plant-derived mouse IgG monoclonal antibody fused to KDEL endoplasmic reticulum-retention signal is N-glycosylated homogeneously throughout the plant with mostly high-mannose-type N-glycans. Plant Biotechnol J 3: 449-457.CrossRefPubMedGoogle Scholar