Comprehensive multi-attribute method workflow for biotherapeutic characterization and current good manufacturing practices testing
The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS)-based method that is used to directly characterize and monitor numerous product quality attributes (PQAs) at the amino acid level of a biopharmaceutical product. MAM enables identity testing based on primary sequen...
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| Veröffentlicht in: | Nature protocols 2023-04, Vol.18 (4), p.1056-1089 |
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| creator | Millán-Martín, Silvia Jakes, Craig Carillo, Sara Rogers, Richard Ren, Da Bones, Jonathan |
| description | The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS)-based method that is used to directly characterize and monitor numerous product quality attributes (PQAs) at the amino acid level of a biopharmaceutical product. MAM enables identity testing based on primary sequence verification, detection and quantitation of post-translational modifications and impurities. This ability to simultaneously and directly determine PQAs of therapeutic proteins makes MAM a more informative, streamlined and productive workflow than conventional chromatographic and electrophoretic assays. MAM relies on proteolytic digestion of the sample followed by reversed-phase chromatographic separation and high-resolution LC-MS analysis in two phases. First, a discovery study to determine quality attributes for monitoring is followed by the creation of a targeted library based on high-resolution retention time plus accurate mass analysis. The second aspect of MAM is the monitoring phase based on the target peptide library and new peak detection using differential analysis of the data to determine the presence, absence or change of any species that might affect the activity or stability of the biotherapeutic. The sample preparation process takes between 90 and 120 min, whereas the time spent on instrumental and data analyses might vary from one to several days for different sample sizes, depending on the complexity of the molecule, the number of attributes to be monitored and the information to be detailed in the final report. MAM is developed to be used throughout the product life cycle, from process development through upstream and downstream processes to quality control release or under current good manufacturing practices regulations enforced by regulatory agencies.
The multi-attribute method directly characterizes and monitors multiple product quality attributes of a biopharmaceutical product via proteolytic digestion of the sample followed by reversed-phase chromatographic separation and high-resolution liquid chromatography-mass spectrometry analysis. |
| doi_str_mv | 10.1038/s41596-022-00785-5 |
| format | Article |
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The multi-attribute method directly characterizes and monitors multiple product quality attributes of a biopharmaceutical product via proteolytic digestion of the sample followed by reversed-phase chromatographic separation and high-resolution liquid chromatography-mass spectrometry analysis.</description><identifier>ISSN: 1754-2189</identifier><identifier>ISSN: 1750-2799</identifier><identifier>EISSN: 1750-2799</identifier><identifier>DOI: 10.1038/s41596-022-00785-5</identifier><identifier>PMID: 36526726</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>631/1647/2067 ; 631/1647/296 ; 631/61/51/1568 ; 631/61/51/2008 ; 639/638/11/296 ; Amino acid sequence ; Amino acids ; Analytical Chemistry ; Antibodies, Monoclonal - chemistry ; Biological Techniques ; Biomedical and Life Sciences ; Biopharmaceuticals ; Chromatography ; Chromatography, Liquid - methods ; Computational Biology/Bioinformatics ; Data analysis ; Digestion ; High resolution ; Impurities ; Libraries ; Life cycles ; Life Sciences ; Liquid chromatography ; Manufacturing ; Mass spectrometry ; Mass Spectrometry - methods ; Mass spectroscopy ; Microarrays ; Monitoring ; Organic Chemistry ; Post-translation ; Product life cycle ; Product quality ; Protein Processing, Post-Translational ; Proteolysis ; Protocol ; Quality control ; Quality management ; Quantitation ; Retention time ; Sample preparation ; Scientific imaging ; Separation ; Workflow</subject><ispartof>Nature protocols, 2023-04, Vol.18 (4), p.1056-1089</ispartof><rights>Springer Nature Limited 2022. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2022. 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MAM enables identity testing based on primary sequence verification, detection and quantitation of post-translational modifications and impurities. This ability to simultaneously and directly determine PQAs of therapeutic proteins makes MAM a more informative, streamlined and productive workflow than conventional chromatographic and electrophoretic assays. MAM relies on proteolytic digestion of the sample followed by reversed-phase chromatographic separation and high-resolution LC-MS analysis in two phases. First, a discovery study to determine quality attributes for monitoring is followed by the creation of a targeted library based on high-resolution retention time plus accurate mass analysis. The second aspect of MAM is the monitoring phase based on the target peptide library and new peak detection using differential analysis of the data to determine the presence, absence or change of any species that might affect the activity or stability of the biotherapeutic. The sample preparation process takes between 90 and 120 min, whereas the time spent on instrumental and data analyses might vary from one to several days for different sample sizes, depending on the complexity of the molecule, the number of attributes to be monitored and the information to be detailed in the final report. MAM is developed to be used throughout the product life cycle, from process development through upstream and downstream processes to quality control release or under current good manufacturing practices regulations enforced by regulatory agencies.
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Academic</collection><jtitle>Nature protocols</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Millán-Martín, Silvia</au><au>Jakes, Craig</au><au>Carillo, Sara</au><au>Rogers, Richard</au><au>Ren, Da</au><au>Bones, Jonathan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comprehensive multi-attribute method workflow for biotherapeutic characterization and current good manufacturing practices testing</atitle><jtitle>Nature protocols</jtitle><stitle>Nat Protoc</stitle><addtitle>Nat Protoc</addtitle><date>2023-04-01</date><risdate>2023</risdate><volume>18</volume><issue>4</issue><spage>1056</spage><epage>1089</epage><pages>1056-1089</pages><issn>1754-2189</issn><issn>1750-2799</issn><eissn>1750-2799</eissn><abstract>The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS)-based method that is used to directly characterize and monitor numerous product quality attributes (PQAs) at the amino acid level of a biopharmaceutical product. MAM enables identity testing based on primary sequence verification, detection and quantitation of post-translational modifications and impurities. This ability to simultaneously and directly determine PQAs of therapeutic proteins makes MAM a more informative, streamlined and productive workflow than conventional chromatographic and electrophoretic assays. MAM relies on proteolytic digestion of the sample followed by reversed-phase chromatographic separation and high-resolution LC-MS analysis in two phases. First, a discovery study to determine quality attributes for monitoring is followed by the creation of a targeted library based on high-resolution retention time plus accurate mass analysis. The second aspect of MAM is the monitoring phase based on the target peptide library and new peak detection using differential analysis of the data to determine the presence, absence or change of any species that might affect the activity or stability of the biotherapeutic. The sample preparation process takes between 90 and 120 min, whereas the time spent on instrumental and data analyses might vary from one to several days for different sample sizes, depending on the complexity of the molecule, the number of attributes to be monitored and the information to be detailed in the final report. MAM is developed to be used throughout the product life cycle, from process development through upstream and downstream processes to quality control release or under current good manufacturing practices regulations enforced by regulatory agencies.
The multi-attribute method directly characterizes and monitors multiple product quality attributes of a biopharmaceutical product via proteolytic digestion of the sample followed by reversed-phase chromatographic separation and high-resolution liquid chromatography-mass spectrometry analysis.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>36526726</pmid><doi>10.1038/s41596-022-00785-5</doi><tpages>34</tpages><orcidid>https://orcid.org/0000-0002-8978-2592</orcidid></addata></record> |
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| subjects | 631/1647/2067 631/1647/296 631/61/51/1568 631/61/51/2008 639/638/11/296 Amino acid sequence Amino acids Analytical Chemistry Antibodies, Monoclonal - chemistry Biological Techniques Biomedical and Life Sciences Biopharmaceuticals Chromatography Chromatography, Liquid - methods Computational Biology/Bioinformatics Data analysis Digestion High resolution Impurities Libraries Life cycles Life Sciences Liquid chromatography Manufacturing Mass spectrometry Mass Spectrometry - methods Mass spectroscopy Microarrays Monitoring Organic Chemistry Post-translation Product life cycle Product quality Protein Processing, Post-Translational Proteolysis Protocol Quality control Quality management Quantitation Retention time Sample preparation Scientific imaging Separation Workflow |
| title | Comprehensive multi-attribute method workflow for biotherapeutic characterization and current good manufacturing practices testing |
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