The First FDA Approved Plant Cell-expressed Drug

May 1, 2012, Pfizer Inc. and Protalix BioTherapeutics, Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) approved ELELYSO™ (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. The enzyme is the first plant-made pharmaceutical to win approval by the U.S. FDA. Expression of proteins in plant cell culture is highly efficient, does not require post-expression modification of the protein, and is not susceptible to contamination by agents such as viruses that are pathological to humans. Using transgenic carrot cells produces a lower cost alternative, and preclinical studies show that the enzyme was well tolerated by patients. A series of clinical studies show that: the production of glucocerebrosidase derived from carrot cells not only has better efficacy, but also has some better safety indicators than the Imiglucerase derived from CHO cell. (LINK)

“ELELYSO™ is the first FDA-approved plant cell-expressed drug for clinical application, this is a landmark event undoubtedly. For Wuhan Healthgen Biotech (which also has the plant expression platform), this is an inspiring news, it proves that the recombinant protein drugs derived from plant expression platform is more safe and effective. Because of advantage of low cost, the plant expression platform will become the trend of the recombinant protein drug’s development.” said Yang Daichang, professor of Wuhan University, the CEO of Wuhan Healthgen Biotechnology Co., Ltd.

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