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In vitro and in vivo modifications of recombinant and human IgG antibodies
Authors:Hongcheng Liu  Gomathinayagam Ponniah  Hui-Min Zhang  Christine Nowak  Alyssa Neill  Nidia Gonzalez-Lopez  Rekha Patel  Guilong Cheng  Adriana Z Kita  Bruce Andrien
Affiliation:1.Protein Characterization; Alexion Pharmaceuticals Inc.; Cheshire, CT USA;2.Bioprocess Development; Merck Research Laboratories; Merck; Kenilworth, NJ USA
Abstract:Tremendous knowledge has been gained in the understanding of various modifications of IgG antibodies, driven mainly by the fact that antibodies are one of the most important groups of therapeutic molecules and because of the development of advanced analytical techniques. Recombinant monoclonal antibody (mAb) therapeutics expressed in mammalian cell lines and endogenous IgG molecules secreted by B cells in the human body share some modifications, but each have some unique modifications. Modifications that are common to recombinant mAb and endogenous IgG molecules are considered to pose a lower risk of immunogenicity. On the other hand, modifications that are unique to recombinant mAbs could potentially pose higher risk. The focus of this review is the comparison of frequently observed modifications of recombinant monoclonal antibodies to those of endogenous IgG molecules.
Keywords:recombinant monoclonal antibodies   endogenous IgG antibodies   posttranslational modifications   pyroglutamate   leader sequence   C-terminal lysine   oligosaccharides
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