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Executive Summary

TRANSGENIC COWS COULD PRODUCE PHARMACEUTICAL PROTEINS at a cost of $1 to $2 per liter versus $50 to $100 for production in a bioreactor, Genzyme VP and General Counsel Mark Hofer asserted Nov. 8 at a Public Health Service Technology Transfer Forum. He estimated per-dose costs at 1 cent to $1 versus $10 to $1,000, respectively. He cited those estimates in concluding that use of transgenic animals to produce pharmaceutical proteins, such as tissue plasminogen activator or blood clotting factors, could be significantly less expensive than producing them through the usual industrial means. The feasibility of using animals to produce human proteins was brought to public attention with the November 1987 publication of a National Institutes of Health/Integrated Genetics study of TPA production in transgenic mice. The following year, Integrated Genetics signed a three-year R&D agreement with Tufts University School of Medicine to fund the development of livestock capable of producing large quantities of human pharmaceuticals in their milk. The company initially is focusing on production of tissue plasminogen activator and protein C ("The Pink Sheet" Oct. 17, 1989, T&G-4). Also in 1988, Transgenic Sciences entered agreements with Tufts School of Veterinary Medicine for production of pharmaceuticals in chicken eggs and with the University of Massachusetts to produce pharmaceuticals in mouse milk ("The Pink Sheet" Feb. 13, 1989, T&G-3). In a separate presentation, the National Institute of Diabetes and Digestive and Kidney Diseases researcher Lothar Henninghausen concurred that shifting production to transgenic animals could have a significant financial impact. "For example, blood clotting Factor VIII is in high demand and the market value is roughly$350 mil. just for the United States," the NIH researcher said. "This is roughly 200 grams of Factor VIII. If you introduce the Factor VIII gene into transgenic farm animals, and it's expressed at very high levels in milk, one sheep or one goat or one pig could be sufficient to provide enough Factor VIII" for the entire U.S. market.

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