ProCellEx® is a next-generation recombinant protein expression system that uses advanced genetic engineering and plant (carrot and tobacco) cell culture technology instead of the traditional mammalian- or yeast-based systems, enabling the production of a wide range of complex, proprietary and biologically equivalent human proteins to address a variety of diseases. Protalix's novel bioreactor system, based on disposable plastic bags, is the first of its kind. The closed system provides stable, optimized conditions, with manufacturing capabilities for the entire range of proteins, including antibodies, complex enzymes, and plant-derived pharmaceuticals.
ProCellEx is the engine behind Protalix's broad pipeline of biotherapeutic candidates, which is led by ELELYSO™ (taliglucerase alfa), which was approved by the U.S. Food and Drug Administration on May 1, 2012 and is the first FDA-approved plant cell-based recombinant therapeutic protein. Subsequently, it was approved by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013, and by the Israeli Ministry of Health in September 2012. It has also been approved by other regulatory agencies for other countries. In Latin America, ELEYSO is marketed as UPLYSO™ (alphataliglucerase). Protalix's plant cell-based approach has the potential to enable the penetration of certain patent-protected markets, thus expanding Protalix´s product opportunities.