Risk Analysis and Safety of Plant-Made Biopharmaceuticals

Risk analysis has been proven to retain the flexibility necessary to make it a useful model system for addressing the countless issues that are found to be associated with plant-derived pharmaceuticals (Wolt and Peterson, 2000). Over the past few years, a great deal of information and experience has steadily accumulated with respect to risk analysis of pharmaceuticals that are currently produced in bacterial and aifimal cell bioreactor systems. Risk analysis has also been performed on transgenic crops used for food production as well as for other applications. As a result, elements from each of these disciplines can be incorporated into the design of optimal production and testing policies and practices. Risk analysis has been employed to cover a series of important issues regarding the large-scale manufacture of plant-made biopharmaceuticals, and will continue to present serious issues for researchers in the academic, corporate, and public health arenas to address (Miele, 1997 Ciliberti and Molinelli, 2005). 

A few plant-derived biopharmaceutical products have now reached advanced clinical trials, and the regulatory process has been developed 

Biopharmaceuticals in Plants Toward the Next Century of Medicine 

A number of potential risks are associated with plant-based pharmaceuticals these include allergen exposure to the public, pollen transfer to wild species, nontarget organism exposure due to persistence of genetically engineered material in the environment, interspecies gene flow, and contamination of nontransgenic crops intended for human consumption. The role of risk analysis with respect to the impact of plant-based biopharmaceuticals on human health and the environment are discussed in this chapter. 

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