Manufacture of recombinant polyclonal antibodies |
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Authors: | S K Rasmussen L K Rasmussen D Weilguny A B Tolstrup |
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Institution: | (1) Symphogen A/S, Electrovej, Building 375, 2800 Lyngby, Denmark |
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Abstract: | Polyclonal antibody therapy in the form of hyper-immune serum has for more than a century been used for treatment of many
infectious diseases. However, with the emergence of first antibiotics and later recombinant monoclonal antibody therapy, the
use of hyper-immune serum has declined. The main reason for this is that methods for consistent manufacturing of safe hyper
immune immunoglobulin products have been lacking. In contrast, manufacturing processes of recombinant monoclonal antibodies
follow a well established schedule and it appears obvious to use similar methods to produce recombinant polyclonal products.
However, the methods for monoclonal antibody manufacturing are, for several reasons, not directly applicable to generation
and manufacture of polyclonal recombinant antibodies. A new production strategy based on recombinant mammalian producer cells
has recently been developed to support consistent generation of recombinant polyclonal antibodies for therapeutic use. This
review describes aspects of this novel technology with emphasis on the generation, production and characterization procedures
employed, and provides comparison with alternative polyclonal and monoclonal antibody manufacturing strategies. |
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Keywords: | Hemolytic disease of the newborn Idiopathic thrombocytopenic purpura Mammalian expression Recombinant polyclonal antibody |
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