Bioanalytical methods for therapeutic monoclonal antibodies and antibody-drug conjugates: A review of recent advances and future perspectives.
Bioanalysis
Liquid chromatography
Mass spectrometry
Therapeutic monoclonal antibodies
antibody–drug conjugate
Journal
Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Titre abrégé: J Pharm Biomed Anal
Pays: England
ID NLM: 8309336
Informations de publication
Date de publication:
05 Feb 2020
05 Feb 2020
Historique:
received:
06
08
2019
revised:
01
11
2019
accepted:
13
11
2019
pubmed:
26
11
2019
medline:
15
12
2020
entrez:
26
11
2019
Statut:
ppublish
Résumé
As the use and development of therapeutic monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) increases, the need for accurate and robust bioanalytical methods is also increasing. Up to about a decade ago, bioanalysis of therapeutic mAbs was performed only by ligand-binding assay (LBA), and this was the only available method for absolute quantitation. Recent technological advances in liquid chromatography (LC)-tandem mass spectrometry (LC-MS/MS) and LC-high-resolution mass spectrometry can realize specific, accurate, and multiplex bioanalysis of these with a wide dynamic detection range. In this review, we introduce recent analytical techniques in bioanalytical methods for therapeutic mAbs and ADCs using LC-MS with three (bottom-up, top-down, and middle-down) proteomics strategies from the viewpoint of improving detection sensitivity, assay accuracy, and selectivity.
Identifiants
pubmed: 31761377
pii: S0731-7085(19)31930-2
doi: 10.1016/j.jpba.2019.112991
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Immunoconjugates
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
112991Informations de copyright
Copyright © 2019 Elsevier B.V. All rights reserved.