Plant cells synthesize biological products
Greening Pharma
Elena Novoselova, STRF, based on Nature Biotechnology:
Pfizer stakes a claim in plant cell–made biopharmaceuticalsDrug production is reaching a new level thanks to the use of synthesis of target proteins in plant cells as an alternative to more expensive synthesis in mammalian and bacterial cells.
Pfizer became the first of the Big Pharma companies to announce the launch of a drug produced by plant cells in bioreactors. The company acquired the rights from the Israeli company Protalix Biotherapeutics to produce taligurase alpha, a form of the enzyme glucocerebrosidase for the treatment of Gaucher disease.
The Protalix bioreactor is a GMP-compliant plant for the production of a number of proteins, including antibodies, enzymes and complex herbal medicines. Protalix has completed the III stage of clinical trials and presented the possibility of a new application for the drug prGCD synthesized in carrot cell culture (it is preparing to enter the market in 2010). The company has already received $65 million from the deal, transferring the rights to the production of prGCD to Pfizer.
The drug rrGCD will compete with the drugs Ceredase Genzyme's (aglucerase is a form of the enzyme beta–glucocerebrosidase isolated from human placental tissue and modified with mannose) and Cerezyme (imiglucerase is a recombinant (cultured) human enzyme beta-glucocerebrosidase, also modified with mannose). Both drugs are used to treat Gaucher's disease (glucosylceramide lipidosis) – a hereditary disease, the most common of lysosomal accumulation diseases. It develops as a result of insufficiency of the enzyme glucocerebrosidase, leading to the accumulation of glucocerebroside in many organs, including the spleen, liver, kidneys, lungs, brain and bone marrow.
It is noteworthy that this is the first example of Pfizer's movement towards the development and production of drugs for the treatment of rare diseases. According to the company's representative Andrew Curtis, Pfizer a year ago defined for itself a strategy for the development of orphan drugs production. The use of an innovative platform for the biosynthesis of drugs in plant cell culture is an important step towards reducing the cost and increasing the efficiency of the production of biopharmaceutical drugs. In addition, Pfizer plans to use the Protalix platform for the synthesis of other drugs in plant cells. These can be both therapeutic agents for the treatment of rare genetic diseases, and biological analogues of existing drugs for which synthesis in plant culture will be cheaper. A biological analogue of the tumor necrosis factor inhibitor alpha Enbrel (etanercept) and a candidate for enzyme replacement therapy of another form of lysosomal accumulation disease, Fabry's disease, have already been released for preclinical trials.
Biolex Therapeutics (USA) is another company that has brought its drug synthesized in a plant cell to the last stage of clinical trials. Their controlled-release interferon α-2b, intended for the treatment of hepatitis C, is synthesized in algae culture. This development attracted the attention and finances of one venture fund, which has already invested $ 60 million in the product.
Portal "Eternal youth" http://vechnayamolodost.ru09.02.2010