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Biopharming, also known as plant molecular farming, refers to the use of genetically modified plants to produce a wide range of pharmaceuticals and industrial products.
Plants such as tobacco, for example, can be genetically engineered to produce therapeutic proteins, monoclonal antibodies and vaccines to treat cancer, inflammatory diseases and other life-threatening or debilitating conditions.
These products are termed plant-made pharmaceuticals (PMP). They belong to a class of pharmaceuticals known more generally as “biologics” or “biopharmaceuticals,” as they are derived from living organisms. (SOURCE: Plant Form https://www.plantformcorp.com/biopharming.aspx)
USDA regulates PMPs during research and development, field trials and production. USDA oversees the process from seed through grain, including the transport and planned introduction of the seed in a greenhouse or field. FDA regulates the evaluation, production and distribution of pharmaceutical products. FDA regulates biologic products and devices, including plant-made pharmaceuticals used as human medicines. FDA also provides additional oversight as needed to ensure the safety of food and feed. (SOURCE: https://www.bio.org/articles/plant-made-pharmaceuticals-background-and-key-points)
The first PMP approved for human use was Elelyso (taliglucerase alfa), an enzyme produced in carrot cells by Israel-based Protalix Biotherapeutics Inc. (commercial rights sold to Pfizer in 2015). The FDA approved Elelyso for Gaucher’s disease in 2012.
IMAGE SOURCE: Creative Commons