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N-Glycan Characterization Via Liquid Chromatography And Mass Spectrometry

Source: Labcorp Biopharmaceutical CMC Services
LIQUID CHROMATOGRAPHY-MASS SPECTROMETER GettyImages-1205683338

Glycosylation is very sensitive to manufacturing parameter consistency. Any change in glycosylation can have a profound impact on an antibody’s therapeutic efficacy, pharmacokinetics/dynamics (PK/PD) and safety, so accurate monitoring and characterization is essential.

If more in-depth characterization of an mAb’s glycan profile is needed (better mass accuracy, single-glycan analysis), there are two options that require minimal additional effort to achieve information on 80%-90% of a product’s glycan population: middle-up LCMS analysis — which can identify and quantify lower-abundance glycans, main glycans, and levels of non-glycosylated product — and peptide map analysis — which can provide information on glycans, other post-translational modifications, and peptide sequence coverage, but is rarely used for glycan analysis alone.

Delve into various techniques for analyzing released glycans and their relative efficacy in HILIC-FLR-MS.

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