12.04.2013 - From its Italian manufacturing site at Garessio, Sanofi has launched large-scale production of semi-synthetic artemisinin, a potent anti-malarial drug.
The launch of the new facility on April 11 represents a further milestone in an anti-malarial drug partnership led by OneWorld Health, a non-profit drug development organisation, with funding from the Bill & Melinda Gates Foundation. Sanofi has invested €10m to build an industrial-scale plant that converts the biological precursor artemisinic acid into artemisinin in reaction steps that involve photochemistry. With its photochemical batch-flow-reactor technology in action, Sanofi envisions a production of 35 tonnes of semi-synthetic artemisinin in 2013, with the first batches available by this summer. It plans to increase capacity to 60 tonnes per year in 2014 and thereafter, which would meet at least a third of the annual global need for the drug. Sanofi hopes to get WHO approval for its product in the coming weeks.
From a technology perspective, the semi-synthetic artemisinin project is a combination of biotechnological and chemical know-how at the industrial scale. Artemisinin is a secondary metabolite extracted from the traditional Chinese medical herb Artemisia annua. However, the botanical supply is subject to climatic variables, leading to a fluctuation in antimalarial medicines and big price variations. Aiming for a stable and more reliable supply of the drug, Jay Keasling and his team at the University of California Berkeley and synthetic biology start-up Amyris genetically engineered yeast cells to produce the precursor artemisinic acid, which must then be converted into artemisinin by synthetic organic chemistry. Sanofi entered the project in 2008 as manufacturing partner with its Access to Medicines programme, and was involved in scaling-up fermentation of artemisinic acid and its conversion into artemisinin using photochemistry. At a facility run by Huverpharma in Bulgaria, an industrial-scale fermentation process was established that could produce up to 100 tonnes of artemisinic acid annually. It is considered as the first industrial-scale deployment of synthetic biology for drug production. Sanofi said it will provide its semi-synthetic artemisinin at a stable price using a non-profit, non-loss production model.
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FILTRODISC™ BIO SD is a filtration system which removes particles (e.g. cells, bacteria, yeast), impurities (e.g. HCP, DNA) and other turbid matter from process liquids (e.g. fermentation broths). more