The invention relates to a method of producing a protein of interest,
comprising making a non-human transgenic mammal that produces said
protein in its milk, obtaining said milk from the non-human transgenic
mammal and purifying said protein of interest from the milk. Transgenic
bovine animals were generated, which are able to produce human growth
hormone in mammary glands. The method involves cloning of a genetic
construct encoding hGH gene and beta casein promoter conveniently in an
expression vector. It also includes transfection procedures into fetal
bovine somatic cells, generally fibroblasts, and the nuclear transfer
into enucleated bovine oocytes, generating thus transgenic embryos. The
method also includes other procedures to generate transgenic embryos for
the further expansion of the transgenic herd, such as the subcloning of
transgenic female bovines, the superovulation of transgenic cows and
their insemination with semen from a non-transgenic or a transgenic male
bovine, and the superovulation of non-transgenic cows and their
insemination with semen from a transgenic male bovine. Afterwards,
transgenic embryos give rise to transgenic cattle that produce human
growth hormone in huge amounts in their milk, from which the hormone is
completely purified and analysed to fulfill all the requirements for the
manufacture of a pure biopharmaceutical product.