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- W3199048439 endingPage "956" @default.
- W3199048439 startingPage "943" @default.
- W3199048439 abstract "The incorporation of the non-human N-glycolylneuraminic acid (Neu5Gc) in therapeutic recombinant proteins raises clinical concerns due to its immunogenic potential and the high prevalence of pre-existing anti-Neu5Gc antibodies in humans. The scientific literature is ambiguous regarding the actual impact of Neu5Gc-containing biotherapeutics as no severe adverse clinical manifestations were unequivocally attributed to Neu5Gc for currently marketed biotherapeutics. This review discusses structural and functional considerations of Neu5Gc-containing glycans regarding the potential impact on drug clearance, their recognition by pre-existing antibodies, and recent hypotheses regarding the tolerance to low Neu5Gc levels. Furthermore, it provides recommendations regarding the standardization of analysis and reporting, analytical aspects relevant for assessing risks associated with Neu5Gc-containing biotherapeutics, and approaches to minimize Neu5Gc incorporation in recombinant protein manufacturing." @default.
- W3199048439 created "2021-09-27" @default.
- W3199048439 creator A5011454541 @default.
- W3199048439 creator A5022260270 @default.
- W3199048439 creator A5067355924 @default.
- W3199048439 creator A5078462563 @default.
- W3199048439 creator A5089889934 @default.
- W3199048439 date "2021-11-01" @default.
- W3199048439 modified "2023-09-27" @default.
- W3199048439 title "Current views on N-glycolylneuraminic acid in therapeutic recombinant proteins" @default.
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