1. Although many human therapeutic proteins are currently produced in
microbial fermenters using recombinant DNA techniques, it is obvious t
hat microbial processing is not suitable for a large number of bioacti
ve proteins owing to the inability of bacteria to carry out postsynthe
tic modification reactions required for full biological activity. 2. T
his disadvantage does not apply to animal cell bioreactors that can ge
nerate biologically fully active entities, yet the use of large-scale
animal cell cultures for production purposes is prohibitively expensiv
e. 3. With the advent of transgenic technology, the production of valu
able human pharmaceuticals in large farm animals (pig, sheep, goat and
dairy cattle) has become more and more attractive as a high-quantity,
low-cost alternative. By employing targeted gene transfer, e.g. using
mammary gland-specific regulatory sequences fused with the desired pr
oduction genes, it is possible to govern the expression to occur exclu
sively in the mammary gland and hence the gene product is being ultima
tely secreted into the milk. 4. While reviewing the remarkable progres
s in this field that has even led to commercial exploitations, we will
outline in somewhat greater detail our strategy for the use of dairy
cattle as a bioreactor for valuable proteins of pharmaceutical interes
t.