Biosafety, Risk Assessment, and Regulation of Molecular Farming

The use of genetically modified plants or plant cells to synthesize proteins that are subsequently processed, regulated, and sold as pharmaceuticals, cosmetics, or industrial products challenges a number of established regulatory frameworks, that is, those concerning genetically modified organisms or living modified organisms, and those covering the development of biotechnology]derived drugs, cosmetics, and medical devices. Guidelines have been published within these regulatory systems to account for plant]made pharmaceuticals, and these guidelines are being fine]tuned as the first such products enter clinical development and reach the market, thus helping to address current regulatory uncertainties. In this chapter, we embark on a journey that covers a diverse range of plant]made biotechnology]derived products that are currently undergoing clinical development or that are already on the market. Using these case studies, we review many of the current plant]based production platforms and consider the merits and drawbacks of each in terms of biosafety, risk assessment, and regulatory compliance.