For almost 50-years, the fractionation of human plasma has been the sole possible source of a wide range of therapeutic proteins-such as coagulation factors, anticoagulants, immunoglobulins, and albumin - essential to the treatment of serious congenital or acquired bleeding or immunological diseases. In the last 20-years, the application of recombinant technologies to mammalian cell cultures has made possible - although with some limitations in productivity, costs, and immunogenic risks - to produce and commercialize complex plasma glycoproteins for human therapeutic applications and has opened the way to the development of new molecular entities. Today, the advanced exploration of alternative cell lines and enhanced cell culture systems, as well as the development of alternative expression technologies, such as transgenic animals, is opening a new era in the production of the full range of recombinant plasma protein therapeutics. In this review, we examine the achievements and ongoing challenges of the recombinant DNA technology as a platform for the production of plasma proteins and the advantages and limitations of such products compared to fractionated plasma proteins.
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