PLANTS AS BIOREACTORS FOR BIOPHARMACEUTICALS - REGULATORY CONSIDERATIONS

Plants are one of several novel hosts that can be used for the product ion of recombinant biopharmaceuticals such as cytokines, hormones, mon oclonal antibodies, enzymes and vaccines. The novelty of this technolo gy and its wide range of potential applications require an assessment of possible regulatory concerns in the clinical development of plant-d erived biopharmaceuticals. General principles extrapolated from experi ence gained with biotechnology products from other sources can serve a s a foundation to develop scientifically sound strategies for the larg e-scale production and clinical development of safe and effective biop harmaceuticals in plant hosts.