Protalix Biotherapeutics develops recombinant human proteins and produces them in plant cell culture. Taliglucerase alfa has been the first biotherapeutic expressed in plant cells to be approved by regulatory authorities around the world. Other therapeutic proteins are being developed and are currently at various stages of the pipeline. This review summarizes the major milestones reached by Protalix Biotherapeutics to enable the development of these biotherapeutics, including platform establishment, cell line selection, manufacturing process and good manufacturing practice principles to consider for the process. Examples of the various products currently being developed are also presented.
Keywords: Protalix Biotherapeutics; enzyme replacement therapy; molecular farming; oral delivery; plant cell culture; β-glucocerebrosidase.
© 2015 Society for Experimental Biology, Association of Applied Biologists and John Wiley & Sons Ltd.