TY - JOUR
T1 - Analytical tools for the characterization of deamidation in monoclonal antibodies
AU - Spanov, Baubek
AU - Govorukhina, Natalia
AU - Merbel, Nico C.van de
AU - Bischoff, Rainer
N1 - Publisher Copyright:
© 2021 The Author(s)
PY - 2022/11
Y1 - 2022/11
N2 - This review focuses on the deamidation of asparagine in monoclonal antibodies, one of the well-known degradation pathways. The importance of close monitoring of deamidation from early developability assessment to in vivo studies is discussed consequentially. The application of chromatographic and electrophoretic instruments for the separation of deamidated variants is described. Current mass spectrometric approaches for characterization of deamidated antibody variants and localization of modification sites are discussed accordingly. The review also covers the challenges in bioanalysis of deamidated forms in complex biological matrices during in vivo studies.
AB - This review focuses on the deamidation of asparagine in monoclonal antibodies, one of the well-known degradation pathways. The importance of close monitoring of deamidation from early developability assessment to in vivo studies is discussed consequentially. The application of chromatographic and electrophoretic instruments for the separation of deamidated variants is described. Current mass spectrometric approaches for characterization of deamidated antibody variants and localization of modification sites are discussed accordingly. The review also covers the challenges in bioanalysis of deamidated forms in complex biological matrices during in vivo studies.
KW - Bioanalys
KW - Deamidation
KW - Ion-exchange chromatography
KW - Mass spectrometry
KW - Monoclonal antibody
UR - https://www.scopus.com/pages/publications/85127402175
U2 - 10.1016/j.jcoa.2021.100025
DO - 10.1016/j.jcoa.2021.100025
M3 - Article
AN - SCOPUS:85127402175
SN - 2772-3917
VL - 2
JO - Journal of Chromatography Open
JF - Journal of Chromatography Open
M1 - 100025
ER -