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ATryn is the brand name of the
anticoagulant An anticoagulant, commonly known as a blood thinner, is a chemical substance that prevents or reduces the coagulation of blood, prolonging the clotting time. Some occur naturally in blood-eating animals, such as leeches and mosquitoes, which ...
antithrombin manufactured by the
Massachusetts Massachusetts ( ; ), officially the Commonwealth of Massachusetts, is a U.S. state, state in the New England region of the Northeastern United States. It borders the Atlantic Ocean and the Gulf of Maine to its east, Connecticut and Rhode ...
-based U.S. company rEVO Biologics (formerly known as GTC Biotherapeutics). It is made from the milk of goats that have been genetically modified to produce human antithrombin, a plasma protein with anticoagulant properties. Microinjection was used to insert human antithrombin genes into the
cell nucleus The cell nucleus (; : nuclei) is a membrane-bound organelle found in eukaryote, eukaryotic cell (biology), cells. Eukaryotic cells usually have a single nucleus, but a few cell types, such as mammalian red blood cells, have #Anucleated_cells, ...
of their
embryo An embryo ( ) is the initial stage of development for a multicellular organism. In organisms that reproduce sexually, embryonic development is the part of the life cycle that begins just after fertilization of the female egg cell by the male sp ...
s. ATryn is the first medicine produced using genetically engineered animals. GTC states that one genetically modified goat can produce the same amount of antithrombin in a year as 90,000 blood donations. GTC chose goats for the process because they reproduce more rapidly than cattle and produce more protein than rabbits or mice. On February 6, 2009, ATryn was approved by the U.S. Food and Drug Administration (FDA) for treatment of patients with hereditary antithrombin deficiency who are undergoing surgical or childbirth procedures. Along with the approval from the FDA's pharmaceutical regulatory board, the Center for Veterinary Medicine of the FDA also approved the genetic makeup of the goats that are used to manufacture ATryn. rEVO has the sole rights to sell ATryn in the United States, and the drug is available in the U.S. market. Earlier in 2006, the
European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...
(EMA) initially rejected and, after an appeal from GTC, approved the drug for use in the
European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...
countries. According to Tom Newberry, the spokesperson for GTC, the company plans to acquire additional approval for treatment of those with non-hereditary antithrombin deficiency. The Humane Society of the United States has said of the process used to manufacture ATryn, "It is a mechanistic use of animals that seems to perpetuate the notion of their being merely tools for human use rather than sentient creatures." However, the genetic changes have no known ill-effects on the host animal.


References


Further reading

* {{cite journal , vauthors=Soler E, Thépot D, Rival-Gervier S, Jolivet G, Houdebine LM , title=Preparation of recombinant proteins in milk to improve human and animal health , journal=Reprod. Nutr. Dev. , volume=46 , issue=5 , pages=579–88 , year=2006 , pmid=17107647 , doi=10.1051/rnd:2006029 , doi-access=free


External links


FDA Product Approval Information for ATryn
Anticoagulants Genetic engineering Goats de:Antithrombin Alfa