Multi-dimensional technology - Recent advances and applications for biotherapeutic characterization.

automated sample preparation complex mAb formats multi-attribute method multi-dimensional liquid chromatography process analytical technology

Journal

Journal of separation science
ISSN: 1615-9314
Titre abrégé: J Sep Sci
Pays: Germany
ID NLM: 101088554

Informations de publication

Date de publication:
Mar 2024
Historique:
revised: 23 01 2024
received: 18 12 2023
accepted: 24 01 2024
medline: 13 3 2024
pubmed: 13 3 2024
entrez: 12 3 2024
Statut: ppublish

Résumé

This review provides an overview of the latest advancements and applications in multi-dimensional liquid chromatography coupled with mass spectrometry (mD-LC-MS), covering aspects such as inter-laboratory studies, digestion strategy, trapping column, and multi-level analysis. The shift from an offline to an online workflow reduces sample processing artifacts, analytical variability, analysis time, and the labor required for data acquisition. Over the past few years, this technique has demonstrated sufficient maturity for application across a diverse range of complex products. Moreover, there is potential for this strategy to evolve into an integrated process analytical technology tool for the real-time monitoring of monoclonal antibody quality. This review also identifies emerging trends, including its application to new modalities, the possibility of evaluating biological activity within the mD-LC set-up, and the consideration of multi-dimensional capillary electrophoresis as an alternative to mD-LC. As mD-LC-MS continues to evolve and integrate emerging trends, it holds the potential to shape the next generation of analytical tools, offering exciting possibilities for enhanced characterization and monitoring of complex biopharmaceutical products.

Identifiants

pubmed: 38471977
doi: 10.1002/jssc.202300928
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

e2300928

Informations de copyright

© 2024 The Authors. Journal of Separation Science published by Wiley-VCH GmbH.

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Auteurs

Thomas Bouvarel (T)

Protein Analytical Chemistry, Genentech, South San Francisco, California, USA.

Julien Camperi (J)

Cell Therapy Engineering and Development, Genentech, South San Francisco, California, USA.

Davy Guillarme (D)

Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, Geneva, Switzerland.
School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.

Classifications MeSH