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Since the introduction of recombinant human growth hormone and
insulin a quarter century ago, protein therapeutics has greatly
broadened the ho- zon of health care. Many patients suffering with
life-threatening diseases or chronic dysfunctions, which were
medically untreatable not long ago, can attest to the wonder these
drugs have achieved. Although the ?rst generation of p- tein
therapeutics was produced in recombinant Escherichia coli, most
recent products use mammalian cells as production hosts. Not long
after the ?rst p- duction of recombinant proteins in E. coli, it
was realized that the complex tasks of most post-translational
modi?cations on proteins could only be ef?ciently carried out in
mammalian cells. In the 1990s, we witnessed a rapid expansion of
mammalian-cell-derived protein therapeutics, chie?y antibodies. In
fact, it has been nearly a decade since the market value of
mammalian-cell-derived protein therapeutics surpassed that of those
produced from E. coli. A common characteristic of recent antibody
products is the relatively large dose required for effective
therapy, demanding larger quantities for the treatment of a given
disease. This, coupled with the broadening repertoire of protein
drugs, has rapidly expanded the quantity needed for clinical
applications. The increasing demand for protein therapeutics has
not been met exclusively by construction of new manufacturing
plants and increasing total volume capacity. More - portantly the
productivity of cell culture processes has been driven upward by an
order of magnitude in the past decade.
Since the introduction of recombinant human growth hormone and
insulin a quarter century ago, protein therapeutics has greatly
broadened the ho- zon of health care. Many patients suffering with
life-threatening diseases or chronic dysfunctions, which were
medically untreatable not long ago, can attest to the wonder these
drugs have achieved. Although the ?rst generation of p- tein
therapeutics was produced in recombinant Escherichia coli, most
recent products use mammalian cells as production hosts. Not long
after the ?rst p- duction of recombinant proteins in E. coli, it
was realized that the complex tasks of most post-translational
modi?cations on proteins could only be ef?ciently carried out in
mammalian cells. In the 1990s, we witnessed a rapid expansion of
mammalian-cell-derived protein therapeutics, chie?y antibodies. In
fact, it has been nearly a decade since the market value of
mammalian-cell-derived protein therapeutics surpassed that of those
produced from E. coli. A common characteristic of recent antibody
products is the relatively large dose required for effective
therapy, demanding larger quantities for the treatment of a given
disease. This, coupled with the broadening repertoire of protein
drugs, has rapidly expanded the quantity needed for clinical
applications. The increasing demand for protein therapeutics has
not been met exclusively by construction of new manufacturing
plants and increasing total volume capacity. More - portantly the
productivity of cell culture processes has been driven upward by an
order of magnitude in the past decade.
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