Page 280 - Binder2
P. 280

Instead, glycosylation depends on the expression system—
               the cell line used to manufacture the biologic—and the
               environment in which that cell is grown.


               A CHO (Chinese Hamster Ovary) cell will add different
               sugars than a human cell. A yeast cell adds different ones
               still. And plants? They add completely foreign glycans—
               structures like β(1,2)-xylose and α(1,3)-fucose—that don’t
               appear anywhere in the human glycome.


                    Glycan        Plant       Human        Regulatory
                   Feature        Type     Equivalent?      Concern

                                                         Immunogenic
                β(1,2)-xylose  Present      No
                                                         in humans

                                            No
                α(1,3)-fucose  Present    (humans use  Immunogenic
                                          α(1,6)-fucose)


                                                         Acceptable,
                High-           Present     Shared       but may affect
                mannose
                                                         clearance

                                Absent
                Sialic acid     (in most    Missing      Reduces serum
                                                         half-life
                                plants)


                                                         May alter

                Paucimannose Common                      receptor
                                          Uncommon
                                                         binding




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