They have four legs, fuzzy faces and udders full of milk. To the uninitiated, they look like dairy goats. To GTC Biotherapeutics Inc, they’re cutting-edge drug-making machines.
The goats being raised on a farm in central Massachusetts are genetically engineered to make a human protein in their milk that prevents dangerous blood clots from forming. The company extracts the protein and turns it into a medicine that fights strokes, pulmonary embolisms and other life-threatening conditions.
GTC has asked the Food and Drug Administration to clear the drug, called ATryn. An expert panel voted overwhelmingly on Friday that it is safe and effective, putting it on the verge of becoming the first drug from a genetically engineered animal to be approved in the US. The agency is expected to make a final decision in February, said the Los Angeles Times.
If approved, the drug would be followed by hundreds of others made from milk produced by genetically engineered goats, cows, rabbits and other animals. Other products in the pipeline are designed to treat people with haemophilia, respiratory diseases and debilitating swollen tissues.
“As soon as we were able to make genetically engineered animals, this was an obvious thing to do,” said James Murray, a geneticist and professor of animal science at UC Davis. “It’s totally cut-and-paste. This is kindergarten stuff with molecular scissors.”
The biotechnology industry is rooting for ATryn. The FDA’s endorsement would signal to Americans that they have nothing to fear from the futuristic technology—and suggest that the millions they’ve invested in the technology could soon begin to pay off.
If the drug is approved, “it takes a big question mark off the table in terms of products that are developed from this technology,” said Samir Singh, president of US operations for Pharming Group, which is developing medicines using milk from genetically engineered cows and rabbits.
The public has had misgivings about eating food from genetically modified animals, and some vocal critics of such technology say the wariness could extend to medicines. “I think many people are going to have the same revulsion,” said Jaydee Hanson, a policy analyst at the Center for Food Safety, a Washington advocacy group that opposes genetic manipulation of food and animals.
For scientists, the appeal is obvious. Many drugs are now synthesized in bioreactors by bacteria or Chinese hamster ovary cells, and they require extensive processing to be suitable for humans. Genetically engineering animals is a better alternative for producing proteins, which form the basis of all biological drugs. “We’re taking advantage of the fact that the mammary gland was designed by nature to make proteins,” said Tom Newberry, GTC’s vice president for government relations.
Sources: The Times Of India