The European Commission approved the first drug mass-produced by whole transgenic animals on Wednesday (August 2). Another similar drug has received fast-track approval status by the U.S. Food and Drug Administration (FDA), suggesting the products may be overcoming long-held concerns over their feasibility.The drug approved in Europe, ATryn, is recombinant human antithrombin, an anticlotting protein secreted into the milk of transgenic goats developed by GTC Biotherapeutics in Framingham, Mass. Last year, ATryn went through regulatory pinball with the European Medicines Evaluation Agency (EMEA), who rejected it in February but then approved it upon further review in June.Biotechnology most often employs cultured mammalian cells to generate protein drugs -- generally, an expensive process. The capital costs for a mammalian cell fermentation system that generates 100 kilograms of drug a year would run from $300 to $500 million, but 150 of GTC's goats can produce roughly the same amount of...
The ScientistPharming GroupJuly 28The ScientistThe Scientist firstname.lastname@example.org://www.transgenics.com/news.htmlThe Scientisthttp://www.the-scientist.com/article/display/15256/http://www.transgenics.com/products/atryn.htmlhttp://www.transgenics.comhttp://www.emea.eu.int/pdfs/human/opinion/QandA_Atryn_6202206en.pdfhttp://www.emea.eu.int/pdfs/general/direct/pr/20316306en.pdfhttp://pharming.com/index.php?act=prodhttp://pharming.com/index.php?act=show&pg=289
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