From proof of concept to the routine use of an automated and robust multi-dimensional liquid chromatography mass spectrometry workflow applied for the charge variant characterization of therapeutic antibodies.


Journal

Journal of chromatography. A
ISSN: 1873-3778
Titre abrégé: J Chromatogr A
Pays: Netherlands
ID NLM: 9318488

Informations de publication

Date de publication:
29 Mar 2020
Historique:
received: 04 09 2019
revised: 05 11 2019
accepted: 26 11 2019
pubmed: 5 12 2019
medline: 12 5 2020
entrez: 5 12 2019
Statut: ppublish

Résumé

The identification and quantification of post-translational modifications (PTMs) is a crucial step required during the development of therapeutic proteins. In particular, the characterization of charge variants separated by cation exchange chromatography (CEX) is a tedious process commonly performed with an off-line manual fraction collection followed by peptide mapping. To improve the efficiency of this time-consuming approach, a generic on-line multi-dimensional LC/MS approach was developed for the characterization of various monoclonal antibody (mAb) isotypes and a bi-specific antibody (BsAb). Fractions collected from

Identifiants

pubmed: 31796250
pii: S0021-9673(19)31172-0
doi: 10.1016/j.chroma.2019.460740
pii:
doi:

Substances chimiques

Antibodies, Monoclonal 0
Peptides 0
Asparagine 7006-34-0
Trypsin EC 3.4.21.4

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

460740

Informations de copyright

Copyright © 2019. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Alexandre Goyon (A)

School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Centre Médical Universitaire (CMU), Rue Michel-Servet 1, 1206, Geneva, Switzerland.

Lu Dai (L)

Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.

Tao Chen (T)

Small Molecule Pharmaceutical Sciences, Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.

Bingchuan Wei (B)

Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.

Feng Yang (F)

Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.

Nisana Andersen (N)

Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.

Robert Kopf (R)

F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070 Basel, Switzerland.

Michael Leiss (M)

Roche Pharma Technical Development, Nonnenwald 2, 82377 Penzberg, Germany.

Michael Mølhøj (M)

Roche Pharma Research and Early Development, Roche Innovation Center Munich, Nonnenwald 2, 82377 Penzberg, Germany.

Davy Guillarme (D)

School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Centre Médical Universitaire (CMU), Rue Michel-Servet 1, 1206, Geneva, Switzerland.

Cinzia Stella (C)

Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: stella.cinzia@gene.com.

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Classifications MeSH