RT Journal Article
T1 Comparing different domains of analysis for the characterisation of N-glycans on monoclonal antibodies.
A1 Carillo, Sara
A1 Perez-Robles, Raquel
A1 Jakes, Craig
A1 Ribeiro da Silva, Meire
A1 Millan Martín, Silvia
A1 Farrell, Amy
A1 Navas, Natalia
A1 Bones, Jonathan
K1 Biopharmaceuticals
K1 Glycan analysis
K1 Glycopeptide analysis
K1 Intact mass analysis
K1 Mass spectrometry
K1 Monoclonal antibodies
K1 N-Glycans
K1 Native mass spectrometry
K1 Peptide mapping
AB With the size of the biopharmaceutical market exponentially increasing, there is an aligned growth in the importance of data-rich analyses, not only to assess drug product safety but also to assist drug development driven by the deeper understanding of structure/function relationships. In monoclonal antibodies, many functions are regulated by N-glycans present in the constant region of the heavy chains and their mechanisms of action are not completely known. The importance of their function focuses analytical research efforts on the development of robust, accurate and fast methods to support drug development and quality control. Released N-glycan analysis is considered as the gold standard for glycosylation characterisation; however, it is not the only method for quantitative analysis of glycoform heterogeneity. In this study, ten different analytical workflows for N-glycan analysis were compared using four monoclonal antibodies. While observing good comparability between the quantitative results generated, it was possible to appreciate the advantages and disadvantages of each technique and to summarise all the observations to guide the choice of the most appropriate analytical workflow according to application and the desired depth of data generated.
PB Elsevier BV
YR 2019
FD 2019-11-27
LK http://hdl.handle.net/10668/15191
UL http://hdl.handle.net/10668/15191
LA en
NO Carillo S, Pérez-Robles R, Jakes C, Ribeiro da Silva M, Millán Martín S, Farrell A, et al. Comparing different domains of analysis for the characterisation of N-glycans on monoclonal antibodies. J Pharm Anal. 2020 Feb;10(1):23-34.
NO The authors gratefully acknowledge funding from Science Foundation Ireland under Grant Number 13/CDA/2196 and collaborators from Thermo Fisher Scientific for instrument access.
DS RISalud
RD Apr 8, 2025