Multi‐Dimensional Technology—Recent Advances and Applications for Biotherapeutic Characterization
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.
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Automated sampling systems such as MAST and Seg-Flow can draw samples from the bioprocess stream and deliver them to analytical devices for seamless analysis.
“Automated sampling systems such as MAST and Seg‐Flow can draw the samples from the bioprocess stream and deliver them to the analytical devices for ensuing seamless analysis [45, 46, 47].”
From Current PAT Landscape in the Downstream Processing of Biopharmaceuticals (2025) · cites this paper as [46]
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Current PAT Landscape in the Downstream Processing of Biopharmaceuticals
Sathiyapriyan, P., Mukherjee, S., Vogel, T., Essen, L., Boerema, D., Vey, M., & Kalina, U. (2025) · Analytical Science Advances · doi:10.1002/ansa.70013 · Cited by 45 · see citing works
- Authors
- Bouvarel, T., Camperi, J., & Guillarme, D.
- Affiliations
- Protein Analytical Chemistry Genentech South San Francisco California USA
- Cell Therapy Engineering and Development Genentech South San Francisco California USA
- Institute of Pharmaceutical Sciences of Western Switzerland University of Geneva Geneva Switzerland
- Venue
- Journal of Separation Science
- Publisher
- Wiley
- Published
- 2024-03
- Volume
- 47
- Issue
- 5
- ISSN
- 1615-9306
- 1615-9314
- Cited by
- 20
- References
- 2
- Language
- en
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