Automated mass spectrometry multi-attribute method analyses for process development and characterization of mAbs
| Autor: | Yann Fromentin, Martin Hoffmann, Yvonne Ehwang Song, Udo Roth, Laurent Duhau, Stephen D́Eri, Hervé Dubois, Anja Pfenninger, Annette Pieper, Jan Wiesner, Séverine Clavier |
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| Rok vydání: | 2020 |
| Předmět: |
Process development
Clinical Biochemistry CHO Cells 030226 pharmacology & pharmacy 01 natural sciences Biochemistry Quality by Design Mass Spectrometry Analytical Chemistry 03 medical and health sciences Automation 0302 clinical medicine Cricetulus Cricetinae Animals Data processing Chromatography Chemistry business.industry 010401 analytical chemistry Comparability Antibodies Monoclonal Cell Biology General Medicine Processes of change 0104 chemical sciences Characterization (materials science) Research Design Systems engineering Critical quality attributes business Hydrophobic and Hydrophilic Interactions Chromatography Liquid |
| Zdroj: | Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. 1166 |
| ISSN: | 1873-376X |
| Popis: | More than 370 biotherapeutics drug products have been approved by regulatory agencies on the US and EU markets and this industry continues to expand. Process change and optimization is necessary to develop new effective biologics in a cost effective and productive way. Consequently, improvement of analytical techniques is required for better product characterization according to Quality by Design (QbD) approach recommended by regulatory agencies. Recently, multi-attribute method (MAM) has emerged to meet such demands using mass spectrometry coupled to liquid chromatography (LC-MS). However, traditional sample preparation or data processing would not be suitable to guide process development, because one of the common challenges during development of analytical platforms is instrument or method variability which can cause deviation in results. Here, we show a new automated analytical platform for MAM implemented on 3 different sites: the components of MAM platform include automated sample preparation, LC-MS based MAM, and data treatment automation. To our knowledge, this is the first study to show global harmonization on automated MAM platforms and the inter-sites comparability including the automated sample preparation and LC-MS instrument. Also, we demonstrate the applicability of MAM to support cell line development, cell culture process development and downstream process development. We expect that this MAM platform will effectively guide process development across multiple projects. |
| Databáze: | OpenAIRE |
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