Multi‐dimensional technology – Recent advances and applications for biotherapeutic characterization

Author:

Bouvarel Thomas1ORCID,Camperi Julien2ORCID,Guillarme Davy34ORCID

Affiliation:

1. Protein Analytical Chemistry Genentech South San Francisco California USA

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

3. Institute of Pharmaceutical Sciences of Western Switzerland University of Geneva Geneva Switzerland

4. School of Pharmaceutical Sciences University of Geneva Geneva Switzerland

Abstract

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.

Publisher

Wiley

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