Application of affinity capillary electrophoresis for charge heterogeneity profiling of biopharmaceuticals
Abstract: Charge heterogeneity profiling is important for the quality control (QC) of biopharmaceuticals. Because of the increasing complexity of these therapeutic entities [1], the development of alternative analytical techniques is needed. In this work, flow‐through partial‐filling affinity capillary electrophoresis (FTPFACE) has been established as a method for the analysis of a mixture of two similar monoclonal antibodies (mAbs). The addition of a specific ligand results in the complexation of one mAb in the co‐formulation, thus changing its migration time in the electric field. This allows the characterization of the charged variants of the non‐shifted mAb without interferences. Adsorption of proteins to the inner capillary wall has been circumvented by rinsing with guanidine hydrochloride before each injection. The presented FTPFACE approach requires only very small amounts of ligands and provides complete comparability with a standard CZE of a single mAb.
- Location
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Deutsche Nationalbibliothek Frankfurt am Main
- Extent
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Online-Ressource
- Language
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Englisch
- Bibliographic citation
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Application of affinity capillary electrophoresis for charge heterogeneity profiling of biopharmaceuticals ; volume:40 ; number:22 ; year:2019 ; pages:3014-3022 ; extent:9
Electrophoresis ; 40, Heft 22 (2019), 3014-3022 (gesamt 9)
- Creator
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Hutanu, Andrei
Kiessig, Steffen
Bathke, Andrea
Ketterer, Rolf
Riner, Sonja
Olaf Stracke, Jan
Wild, Markus
Moritz, Bernd
- DOI
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10.1002/elps.201900233
- URN
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urn:nbn:de:101:1-2022072908122053091110
- Rights
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Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
- Last update
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15.08.2025, 7:30 AM CEST
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Associated
- Hutanu, Andrei
- Kiessig, Steffen
- Bathke, Andrea
- Ketterer, Rolf
- Riner, Sonja
- Olaf Stracke, Jan
- Wild, Markus
- Moritz, Bernd
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