GM Carrot Cells Used to Create ELELYSO™ - First Plant Cell Enzyme Replacement TherapyGM carrot cells form the base of the first plant-cell enzyme replacement therapy (ERT) approved by the U.S. Food and Drug Administration (FDA) on 1 May 2012. The approved ERT was created by Pfizer Inc.and Protalix BioTherapeutics, Inc. It is trademarked as ELELYSO™ (taliglucerase alfa). It is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat type 1 Gaucher disease. It is the first plant cell-expressed drug made by ProCellEx®, Protalix's proprietary manufacturing system.
|GM carrots being processed in Protalix's bioreactor plant cell system. |
This system was created to manufacture a range of proteins, including antibodies, complexenzymes and plant-derived pharmaceuticals. Photo: Protalix
Pfizer and Protalix BioTherapeutics, Inc. teamed to develop and commercialize ELELYSO™ on 30 November 2009. Under their agreement, Protalix has retained exclusive commercialization rights in Israel, while Pfizer received exclusive licensing rights for the commercialization in all other markets.
Fox, Jeffrey L. "First plant-made biologic approved," Nature Biotechnology, 30, 472 (2012), Published online 7 June 2012.
Ratner, Mark. "Pfizer stakes a claim in plant cell–made biopharmaceuticals, Nature Biotechnology 28, 107–108 (2010) doi:10.1038/nbt0210-107.