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Change of charge variant composition of trastuzumab upon stressing at physiological conditions. / Spanov, Baubek; Olaleye, Oladapo; Lingg, Nico; Bentlage, Arthur E. H.; Govorukhina, Natalia; Hermans, Jos; van de Merbel, Nico; Vidarsson, Gestur; Jungbauer, Alois; Bischoff, Rainer.

In: Journal of chromatography, Vol. 1655, 462506, 11.10.2021.

Research output: Contribution to journalArticleAcademicpeer-review

Harvard

Spanov, B, Olaleye, O, Lingg, N, Bentlage, AEH, Govorukhina, N, Hermans, J, van de Merbel, N, Vidarsson, G, Jungbauer, A & Bischoff, R 2021, 'Change of charge variant composition of trastuzumab upon stressing at physiological conditions', Journal of chromatography, vol. 1655, 462506. https://doi.org/10.1016/j.chroma.2021.462506

APA

Spanov, B., Olaleye, O., Lingg, N., Bentlage, A. E. H., Govorukhina, N., Hermans, J., van de Merbel, N., Vidarsson, G., Jungbauer, A., & Bischoff, R. (2021). Change of charge variant composition of trastuzumab upon stressing at physiological conditions. Journal of chromatography, 1655, [462506]. https://doi.org/10.1016/j.chroma.2021.462506

Vancouver

Spanov B, Olaleye O, Lingg N, Bentlage AEH, Govorukhina N, Hermans J et al. Change of charge variant composition of trastuzumab upon stressing at physiological conditions. Journal of chromatography. 2021 Oct 11;1655. 462506. https://doi.org/10.1016/j.chroma.2021.462506

Author

Spanov, Baubek ; Olaleye, Oladapo ; Lingg, Nico ; Bentlage, Arthur E. H. ; Govorukhina, Natalia ; Hermans, Jos ; van de Merbel, Nico ; Vidarsson, Gestur ; Jungbauer, Alois ; Bischoff, Rainer. / Change of charge variant composition of trastuzumab upon stressing at physiological conditions. In: Journal of chromatography. 2021 ; Vol. 1655.

BibTeX

@article{30ef7c0eefdf42a3809cfb72fd3f1d0f,
title = "Change of charge variant composition of trastuzumab upon stressing at physiological conditions",
abstract = "Cation-exchange chromatography is a widely used approach to study charge heterogeneity of monoclonal antibodies. Heterogeneity may arise both in vitro and in vivo because of the susceptibility of monoclonal antibodies to undergo chemical modifications. Modifications may adversely affect the potency of the drug, induce immunogenicity or affect pharmacokinetics. In this study, we evaluated the application of optimized pH gradient systems for the separation of charge variants of trastuzumab after forced degradation study. pH gradient-based elution resulted in high-resolution separation of some 20 charge variants after 3 weeks at 37°C under physiological conditions. The charge variants were further characterized by LC-MS-based peptide mapping. There was no significant difference in the binding properties to HER2 or a range of Fcγ receptors between non-stressed and stressed trastuzumab.",
keywords = "Cation-exchange chromatography, Charge variants, Peptide mapping, Trastuzumab, pH gradient",
author = "Baubek Spanov and Oladapo Olaleye and Nico Lingg and Bentlage, {Arthur E. H.} and Natalia Govorukhina and Jos Hermans and {van de Merbel}, Nico and Gestur Vidarsson and Alois Jungbauer and Rainer Bischoff",
note = "Funding Information: B.S. and O.O. are funded by a grant of the European Commission (H2020 MSCA-ITN 2017 “Analytics for Biologics”, grant agreement ID 765502) Publisher Copyright: {\textcopyright} 2021",
year = "2021",
month = oct,
day = "11",
doi = "10.1016/j.chroma.2021.462506",
language = "English",
volume = "1655",
journal = "Journal of chromatography",
issn = "0378-4347",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - Change of charge variant composition of trastuzumab upon stressing at physiological conditions

AU - Spanov, Baubek

AU - Olaleye, Oladapo

AU - Lingg, Nico

AU - Bentlage, Arthur E. H.

AU - Govorukhina, Natalia

AU - Hermans, Jos

AU - van de Merbel, Nico

AU - Vidarsson, Gestur

AU - Jungbauer, Alois

AU - Bischoff, Rainer

N1 - Funding Information: B.S. and O.O. are funded by a grant of the European Commission (H2020 MSCA-ITN 2017 “Analytics for Biologics”, grant agreement ID 765502) Publisher Copyright: © 2021

PY - 2021/10/11

Y1 - 2021/10/11

N2 - Cation-exchange chromatography is a widely used approach to study charge heterogeneity of monoclonal antibodies. Heterogeneity may arise both in vitro and in vivo because of the susceptibility of monoclonal antibodies to undergo chemical modifications. Modifications may adversely affect the potency of the drug, induce immunogenicity or affect pharmacokinetics. In this study, we evaluated the application of optimized pH gradient systems for the separation of charge variants of trastuzumab after forced degradation study. pH gradient-based elution resulted in high-resolution separation of some 20 charge variants after 3 weeks at 37°C under physiological conditions. The charge variants were further characterized by LC-MS-based peptide mapping. There was no significant difference in the binding properties to HER2 or a range of Fcγ receptors between non-stressed and stressed trastuzumab.

AB - Cation-exchange chromatography is a widely used approach to study charge heterogeneity of monoclonal antibodies. Heterogeneity may arise both in vitro and in vivo because of the susceptibility of monoclonal antibodies to undergo chemical modifications. Modifications may adversely affect the potency of the drug, induce immunogenicity or affect pharmacokinetics. In this study, we evaluated the application of optimized pH gradient systems for the separation of charge variants of trastuzumab after forced degradation study. pH gradient-based elution resulted in high-resolution separation of some 20 charge variants after 3 weeks at 37°C under physiological conditions. The charge variants were further characterized by LC-MS-based peptide mapping. There was no significant difference in the binding properties to HER2 or a range of Fcγ receptors between non-stressed and stressed trastuzumab.

KW - Cation-exchange chromatography

KW - Charge variants

KW - Peptide mapping

KW - Trastuzumab

KW - pH gradient

UR - http://www.scopus.com/inward/record.url?scp=85114219481&partnerID=8YFLogxK

U2 - 10.1016/j.chroma.2021.462506

DO - 10.1016/j.chroma.2021.462506

M3 - Article

C2 - 34492576

VL - 1655

JO - Journal of chromatography

JF - Journal of chromatography

SN - 0378-4347

M1 - 462506

ER -

ID: 19612080