Article: Biopharmaceutical production in transgenic plants: Toward development of regulatory guidelines

The potential of crop plants in the production of recombinant biopharmaceuticals is beginning to be realized. The ease by which foreign genes can be introduced, the use of novel promoters for controlling protein expression, the relative speed at which a single plant can be scaled up to cover acres of land, and the very low cost of biomass creation are all contributing to rapid development of both seed-based and leaf-based crops as bioreactors. At least three plant-produced biologics have entered human clinical trials, and that number will increase dramatically over the next couple of years (1).

Such developments not only have important implications for large-scale biopharmaceutical ...

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