White Papers :
Transgenic Animals
- Case Study: Farm Animal (Goat) that Produces Human Drugs
This case study examines in a general way the proposed use of genetically
engineered animals to produce protein biologics for use in human therapy, referred to
herein as human biologics 1 , human proteins, or transgenic proteins, including the
disposition of those animals. The case study uses the example of a goat engineered to
express a human protein in its milk. The protein is then extracted and purified for
therapeutic use in humans. While there are products under review, because no such
product has completed the Food and Drug Administration (FDA) regulatory process, this
case study is relatively general.
CEQ/OSTP Assessment: Case Studies of Environmental Regulation for Biotechnology January, 2001