European regulators have not given the green signal to a drug produced in the milk of genetically engineered farm animals// . This is a step retrograde to a budding industry that sought to enable low cost pharmaceutical options from farm animals
GTC Biotherapeutics, proponents of this drug, have decided to appeal the decision, expressing their opinion that the verdict came about only on the basis of a problem in the clinical trial, and certainly not from the fact that the drug was produced in the goats.
With a new technology there is a conservatism that is not inappropriate, Geoffrey Cox, chief executive of GTC, said during a conference call with analysts. But he added, There is no way with this company and what we have achieved over 15 years that we will let this block us from getting the product to market.
Companies like the GTC inject human genes into the animals that cause them to produce a human protein in their milk. The animal’s milk can then be used to extract the protein which can later be purified and used as a drug.
This method is cost effective and less cumbersome to produce such types of biotechnology drugs. Cancer-fighting monoclonal antibodies and many such drugs are produced using cultures of genetically engineered animal cells. These factories are a very expensive proposition costing several hundred million dollars for each factory.
Many other protein drugs, similar to the one developed by GTC, are done after the protein is extracted from donated blood. But these quantities in donated blood are found in very minimal quantities and run short to meet the actual demand. According to GTC, almost 90,000 blood donations would be required to produce the amount of protein the goats can produce in just one year.
Drug companies have been reticent to try this technology, mainly because of the wariness portrayed by drug regulators. GTC now proposes to seek the approval on its own steam to
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