Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control
ABSTRACTThe multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has gained increased interest and applications in the biopharmaceutical industry. MAM can, in one method, provide targeted quantitation of multiple site-specific product quality...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | mAbs |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/19420862.2023.2197668 |
| _version_ | 1797356273947115520 |
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| author | Feng Yang Jennifer Zhang Alexander Buettner Eva Vosika Monica Sadek Zhiqi Hao Dietmar Reusch Maximiliane Koenig Wayman Chan Anja Bathke Hilary Pallat Victor Lundin Jochen Felix Kepert Patrick Bulau Galahad Deperalta Christopher Yu Richard Beardsley Tura Camilli Reed Harris John Stults |
| author_facet | Feng Yang Jennifer Zhang Alexander Buettner Eva Vosika Monica Sadek Zhiqi Hao Dietmar Reusch Maximiliane Koenig Wayman Chan Anja Bathke Hilary Pallat Victor Lundin Jochen Felix Kepert Patrick Bulau Galahad Deperalta Christopher Yu Richard Beardsley Tura Camilli Reed Harris John Stults |
| author_sort | Feng Yang |
| collection | DOAJ |
| description | ABSTRACTThe multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has gained increased interest and applications in the biopharmaceutical industry. MAM can, in one method, provide targeted quantitation of multiple site-specific product quality attributes, as well as new peak detection. In this review, we focus on the scientific and regulatory considerations of using MAM in product quality attribute monitoring and quality control (QC) of therapeutic proteins. We highlight MAM implementation challenges and solutions with several case studies, and provide our perspective on the opportunities to use MS in QC for applications other than standard peptide mapping-based MAM. |
| first_indexed | 2024-03-08T14:24:15Z |
| format | Article |
| id | doaj.art-7874d2b0e1c34b02adff141b78f9fabe |
| institution | Directory Open Access Journal |
| issn | 1942-0862 1942-0870 |
| language | English |
| last_indexed | 2024-03-08T14:24:15Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | mAbs |
| spelling | doaj.art-7874d2b0e1c34b02adff141b78f9fabe2024-01-13T11:27:51ZengTaylor & Francis GroupmAbs1942-08621942-08702023-12-0115110.1080/19420862.2023.2197668Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality controlFeng Yang0Jennifer Zhang1Alexander Buettner2Eva Vosika3Monica Sadek4Zhiqi Hao5Dietmar Reusch6Maximiliane Koenig7Wayman Chan8Anja Bathke9Hilary Pallat10Victor Lundin11Jochen Felix Kepert12Patrick Bulau13Galahad Deperalta14Christopher Yu15Richard Beardsley16Tura Camilli17Reed Harris18John Stults19Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, GermanyPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, GermanyPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, GermanyLarge Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Munich, Penzberg, GermanyPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, SwitzerlandPharma Quality & Compliance–Analytical Science, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, GermanyPharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, SwitzerlandPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Regulatory, Genentech, A Member of the Roche Group, South San Francisco, CA, USAPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAPharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USAABSTRACTThe multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has gained increased interest and applications in the biopharmaceutical industry. MAM can, in one method, provide targeted quantitation of multiple site-specific product quality attributes, as well as new peak detection. In this review, we focus on the scientific and regulatory considerations of using MAM in product quality attribute monitoring and quality control (QC) of therapeutic proteins. We highlight MAM implementation challenges and solutions with several case studies, and provide our perspective on the opportunities to use MS in QC for applications other than standard peptide mapping-based MAM.https://www.tandfonline.com/doi/10.1080/19420862.2023.2197668product quality attributequality controlLC-MSmulti-attribute methodIntact MAMtargeted attribute quantitation |
| spellingShingle | Feng Yang Jennifer Zhang Alexander Buettner Eva Vosika Monica Sadek Zhiqi Hao Dietmar Reusch Maximiliane Koenig Wayman Chan Anja Bathke Hilary Pallat Victor Lundin Jochen Felix Kepert Patrick Bulau Galahad Deperalta Christopher Yu Richard Beardsley Tura Camilli Reed Harris John Stults Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control mAbs product quality attribute quality control LC-MS multi-attribute method Intact MAM targeted attribute quantitation |
| title | Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control |
| title_full | Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control |
| title_fullStr | Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control |
| title_full_unstemmed | Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control |
| title_short | Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control |
| title_sort | mass spectrometry based multi attribute method in protein therapeutics product quality monitoring and quality control |
| topic | product quality attribute quality control LC-MS multi-attribute method Intact MAM targeted attribute quantitation |
| url | https://www.tandfonline.com/doi/10.1080/19420862.2023.2197668 |
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