ATryn is the brand name of the anticoagulant

antithrombin Antithrombin (AT) is a small glycoprotein that inactivates several enzymes of the coagulation system. It is a 432-amino-acid protein produced by the liver. It contains three disulfide bonds and a total of four possible glycosylation sites. α-A ...

manufactured by the

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-based U.S. company rEVO Biologics (formerly known as GTC Biotherapeutics). It is made from the milk of goats that have been

genetically modified Genetic engineering, also called genetic modification or genetic manipulation, is the modification and manipulation of an organism's genes using technology. It is a set of technologies used to change the genetic makeup of cells, including ...

to produce human antithrombin, a

plasma protein Blood-proteins, also termed plasma proteins, are proteins present in blood plasma. They serve many different functions, including transport of lipids, hormones, vitamins and minerals in activity and functioning of the immune system. Other blood pr ...

with anticoagulant properties.

Microinjection Microinjection is the use of a glass micropipette to inject a liquid substance at a microscopic or borderline macroscopic level. The target is often a living cell but may also include intercellular space. Microinjection is a simple mechanical pro ...

was used to insert human antithrombin genes into the cell nucleus of their embryos. 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 The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(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 The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from whi ...

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 (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 political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been de ...

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 The Humane Society of the United States (HSUS) is an American nonprofit organization that focuses on animal welfare and opposes animal-related cruelties of national scope. It uses strategies that are beyond the abilities of local organizations. ...

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 change has no known ill-effects on the host animal.

References

External links

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

References

Further reading

External links