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Comparison of Fc N-Glycosylation of Pharmaceutical Products of Intravenous Immunoglobulin G.


ABSTRACT: Intravenous immunoglobulin (IVIg) products from different pharmaceutical companies vary in composition, in part because of the selected blood donors and production process. N-glycosylation of the Fc-portion of IgG varies between blood donors and may influence both the side-effects and therapeutic effectiveness of IVIg. At present, the variation in Fc N-glycosylation between IVIg products has not been defined. Utilizing mass spectrometry, we performed relative quantitation of the Fc N-glycosylation of IgG, assessing a total of 154 unique lot numbers of IVIg. Seven products showed comparable Fc N-glycosylation, with only one product differing from the others in all glycosylation features (galactosylation, sialylation, fucosylation and bisecting N-acetylglucosamine). However, the mean difference did not exceed 3%. Within product variation was present to a minor degree, but largely indistinguishable from analytical variation. In conclusion, we expect that the minor variation in Fc N-glycosylation between IVIg products has a small effect, if any, on the biological activity.

SUBMITTER: Fokkink WJ 

PROVIDER: S-EPMC4601728 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Comparison of Fc N-Glycosylation of Pharmaceutical Products of Intravenous Immunoglobulin G.

Fokkink Willem Jan R WJ   Falck David D   Santbergen Tom C M TC   Huizinga Ruth R   Wuhrer Manfred M   Jacobs Bart C BC  

PloS one 20151012 10


Intravenous immunoglobulin (IVIg) products from different pharmaceutical companies vary in composition, in part because of the selected blood donors and production process. N-glycosylation of the Fc-portion of IgG varies between blood donors and may influence both the side-effects and therapeutic effectiveness of IVIg. At present, the variation in Fc N-glycosylation between IVIg products has not been defined. Utilizing mass spectrometry, we performed relative quantitation of the Fc N-glycosylati  ...[more]

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