In the mid 1980's, a few pioneering companies undertook the risk of de
veloping 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-l-antitrypsin are making their way through human clinical trial
s. It is projected that licensure by the Regulatory agencies and marke
t launch for these transgenically produced therapeutics will occur aro
und the year 2000. Although much has already been achieved, additional
transgenic challenges await the basic embryo researcher and practitio
ner. The biopharming community recognizes the need for additional inno
vative methodologies (such as cloning, sperm sexing and retroviral med
iated gene transfer etc.) to overcome the natural biological barriers
and increase the efficiency of transgenic dairy animal production and
rapid herd expansion. (C) 1998 by Elsevier Science Inc.