Applications for LC & LCMS/MS

 

High Sensitivity Profiling of Glycans in Antibody Drugs Using RF-20AXS

Glycans, or sugar chains, in antibody drugs play roles in the antigenicity, pharmacokinetics, and stability of higher-order structure, which could adversely affect their safety and effectiveness. Further, there is also concern about the non-uniformity of these glycans due to instability of antibody drug culture conditions, which has heightened the necessity to manage their production process. However, while there is currently no glycan test method specified in the Japanese Pharmacopoeia, there is wide demand for an assessment method. Here, we introduce an example of analysis of glycans in antibody drugs using the Nexera X2 ultra high performance liquid chromatograph with the RF-20AXS high-sensitivity fluorescence detector. For the analysis, the Phenomenex core-shell, high-speed analytical AerisTM PEPTIDE XB-C18 column was used. Since the permeability of the packing material is optimized for analysis of high-molecular compounds such as peptides, the column is useful for separation of glycans and impurities in antibody drugs.

 
 
 
 
 

N-glycan Profiling of monoclonal Antibodies (mAb) on Nexera Bio UHPLC Coupled with Fluorescense Detector and Q-TOF Mass Spectrometer

N-linked Glcosylation on Asn residue with consensus sequence Asn-X-Ser/thr (where X is an amino acid except Pro) plays a critical role in stability, bioactivity and immunogenicity of monoclonal antibodies. The N-Glycan moieties of therapeutic mAbs, especially biosimilar products, must be adequately and routinely characterized to ensure product quality. In the report, we established a robust, sensitive and reproducible analytical platform that contains a Nexera Bio UHPLC system, a fluorescense detector and a Q-TOF mass spectrometer for N-Glycan profiling of bevacizumab biosimilar.

 
 
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