Commercialization of proteins produced in the mammary gland

In the mid 1980's, few pioneering companies undertook the risk of developing methodologies for the production of complex human therapeutic proteins in the milk of transgenic animals. As we approach the end of the 1990's, the prospect of achieving this aim is becoming a reality as the first of these human therapeutic products, antithrombin III and alpha-1-antitrypsin are making their way through human clinical trials. It is projected that licensure by the Regulatory agencies and market launch for these transgenically produced therapeutics will occur around the year 2000. Although much has already been achieved, additional transgenic challenges await the basic embryo researcher and practitioner. The biopharming community recognizes the need for additional innovative methodologies (such as cloning, sperm sexing and retroviral mediated gene transfer etc.) to overcome the natural biological barriers and increase the efficiency of transgenic dairy animal production and rapid herd expansion.