Biopharmaceuticals in Plants: Toward the Next Century of Medicine By Kathleen Laura Hefferon.
The cost-effective, large-scale production of biopharmaceuticals by transgenic plants represents a long-standing goal in the field of molecular plant biotechnology, better known as molecular farming. Since the first successful production of a monoclonal antibody in tobacco twenty years ago, an enormous body of literature has accumulated, describing a broad range of plant host systems for biopharmaceutical production, including plant cell cultures, unicellular plants, aquatic plants grown in containment, and most notably transgenic food and non-food crops, which can be grown in greenhouses or in the open field. Currently there is an urgent need for a text book providing guidance through this substantial amount of primary literature, as well as putting the described findings into perspective with competing expression systems. The book by Dr. Kathleen Laura Hefferon attempts to provide this guidance. The book is divided into nine chapters covering a wide
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range of subjects related to generation of transgenic plants and biopharmaceuticals in general, risk analysis of recombinant protein production in plants, and the economics concerning biopharmaceutical production. Chapter 1 provides an overview of the different transformation technologies developed for the generation of transgenic plants, with much attention given to the Agrobacterium-mediated transformation technology. The introductory chapter then further attempts to provide very short but detailed introductions to highly complex and often very specific problems related to plant gene regulation, the use of synthetic genes, and problems associated with gene silencing. Unfortunately these short paragraphs Qeither introduce the subject adequately to the novice nor provide a useful overview for the more experience researcher in the field. Chapter 2 gives a comprehensive overview of the different therapeutic proteins already produced in plants, including some background information on their pharmaceutical use. With almost a dozen biopharmaceuticals derived from plant expression systems currently in clinical developments and at least two products approved for use in humans, a section focusing on these success stories would have added significantly to the content of the chapter. Chapters 3 and 4 are devoted to the genetic engineering of plant protoplasts for biopharmaceutical production and the use of viral expression systems, respectively. Chapter 5 addresses the issue of different glycosylation patterns be-
Š 2010 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim
tween plant- and mammalian-derived proteins and the prospects in "humanizing" plant-derived therapeutic proteins. Probably the most interesting sections for the more experienced researcher are Chapters 6 and 8 entitled Scale-Up of Plant-Derived Pharmaceuticals: Prospects for commercial production and for Global Health and Risk Analysis and Safety of Plant-Made Biopharmaceuticals, respec-
tively. Despite the promised benefits of plant systems, in particular with regard to safety and cost effectiveness, commercialization of the products are still often overshadowed by uncertainties related to regulatory issues, adaptation of good manufacturing practice to plant cultivation, etc. Chapter 8 provides a short introduction to the regulatory framework and approval process applicable to plant-derived biopharmaceuticals. Today, molecular farming represents an extremely heterogeneous field, due to the large variety of different production hosts examined and further complications derived from the different cultivation systems employed. In spite of the shortcomings described above, the book provides a comprehensive overview of the different approaches taken over the last 20 years since the first heterologous expression of a monoclonal antibody in tobacco. Dr. Stefan Jennewein
Fraunhofer Institute for Molecular Biology and Applied Ecology (Germany) 001: 10.1002/cmdc.201000451
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