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Goats milk used for blood thinning drugs..DNA and Proteins at work

Posted Jan 11 2009 4:20pm

The drug, ATryn has already been approved in Europe.  Up until now the drug has been created from blood from human donors.  The drug is used to prevent blood clots and would be used during surgery given via an IV, and would not replace normal prescribed blood thinners taken as a normal treatment plan. 

“Milk from transgenic goats is collected according to standard operating procedures that meet or exceed established practice for the dairy industry. GTC Biotherapeutics has developed a highly efficient proprietary process for the recovery of biologically active proteins from this milk. This process typically begins with direct filtration of raw milk under specific conditions that remove fat, casein, cells and particulates. This is followed by a capture chromatography step that is specific for the particular protein. Additional chromatography steps are then used to achieve high level purity of the protein.”

WASHINGTON (AP) — You've heard of making cheese from goats' milk, but prescription drugs? In what would be a scientific first, an anti-clotting drug made from the milk of genetically engineered goats moved closer to government approval Wednesday after experts at the Food and Drug Administration reported that the medication works and its safety is acceptable.

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Called ATryn, the drug is intended to help people with a rare hereditary disorder that makes them vulnerable to life-threatening blood clots.  To make the drug, scientists at GTC put DNA for the human antithrombin protein into single cell embryos of goats. Goat embryos with the gene were then inserted into the wombs of surrogate mothers who gave birth to baby goats carrying the new trait.

Its approval would be a major step toward new kinds of medications made not from chemicals, but from living organisms genetically manipulated by scientists. Similar drugs could be available in the next few years for a range of human ailments, including hemophilia.

Scientific advisers to the FDA will weigh the risks and benefits of ATryn at a meeting Friday, and make a recommendation on approval. The FDA will make the final decision.

The Associated Press: Drug from genetically engineered goats a first

Technorati Tags: FDA, drugs, pharma, genomics, DNA, healthcare
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