Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control
The 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 attribut...
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| Veröffentlicht in: | mAbs 2023-12, Vol.15 (1), p.2197668-2197668 |
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| creator | Yang, Feng Zhang, Jennifer Buettner, Alexander Vosika, Eva Sadek, Monica Hao, Zhiqi Reusch, Dietmar Koenig, Maximiliane Chan, Wayman Bathke, Anja Pallat, Hilary Lundin, Victor Kepert, Jochen Felix Bulau, Patrick Deperalta, Galahad Yu, Christopher Beardsley, Richard Camilli, Tura Harris, Reed Stults, John |
| description | The 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. |
| doi_str_mv | 10.1080/19420862.2023.2197668 |
| format | Article |
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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.</description><identifier>ISSN: 1942-0862</identifier><identifier>EISSN: 1942-0870</identifier><identifier>DOI: 10.1080/19420862.2023.2197668</identifier><identifier>PMID: 37057828</identifier><language>eng</language><publisher>United States: Taylor & Francis</publisher><subject>Antibodies, Monoclonal - chemistry ; Biological Products ; cGMP ; Chromatography, Liquid - methods ; GMP ; Intact MAM ; LC-MS ; Mass Spectrometry - methods ; MS in QC ; multi-attribute method ; new peak detection ; product quality attribute ; Quality Control ; Review ; targeted attribute quantitation</subject><ispartof>mAbs, 2023-12, Vol.15 (1), p.2197668-2197668</ispartof><rights>2023 Genentech, A Member of the Roche Group, South San Francisco, CA 94080, USA. 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Published with license by Taylor & Francis Group, LLC. 2023 Genentech, A Member of the Roche Group, South San Francisco, CA 94080, USA</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c535t-efdc4ba8fc1e51586a25d8ace18e46dc41897e52619b840fb48fe2f6115fce063</citedby><cites>FETCH-LOGICAL-c535t-efdc4ba8fc1e51586a25d8ace18e46dc41897e52619b840fb48fe2f6115fce063</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10114992/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10114992/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,27479,27901,27902,53766,53768,59116,59117</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37057828$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yang, Feng</creatorcontrib><creatorcontrib>Zhang, Jennifer</creatorcontrib><creatorcontrib>Buettner, Alexander</creatorcontrib><creatorcontrib>Vosika, Eva</creatorcontrib><creatorcontrib>Sadek, Monica</creatorcontrib><creatorcontrib>Hao, Zhiqi</creatorcontrib><creatorcontrib>Reusch, Dietmar</creatorcontrib><creatorcontrib>Koenig, Maximiliane</creatorcontrib><creatorcontrib>Chan, Wayman</creatorcontrib><creatorcontrib>Bathke, Anja</creatorcontrib><creatorcontrib>Pallat, Hilary</creatorcontrib><creatorcontrib>Lundin, Victor</creatorcontrib><creatorcontrib>Kepert, Jochen Felix</creatorcontrib><creatorcontrib>Bulau, Patrick</creatorcontrib><creatorcontrib>Deperalta, Galahad</creatorcontrib><creatorcontrib>Yu, Christopher</creatorcontrib><creatorcontrib>Beardsley, Richard</creatorcontrib><creatorcontrib>Camilli, Tura</creatorcontrib><creatorcontrib>Harris, Reed</creatorcontrib><creatorcontrib>Stults, John</creatorcontrib><title>Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control</title><title>mAbs</title><addtitle>MAbs</addtitle><description>The 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. 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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.</description><subject>Antibodies, Monoclonal - chemistry</subject><subject>Biological Products</subject><subject>cGMP</subject><subject>Chromatography, Liquid - methods</subject><subject>GMP</subject><subject>Intact MAM</subject><subject>LC-MS</subject><subject>Mass Spectrometry - methods</subject><subject>MS in QC</subject><subject>multi-attribute method</subject><subject>new peak detection</subject><subject>product quality attribute</subject><subject>Quality Control</subject><subject>Review</subject><subject>targeted attribute quantitation</subject><issn>1942-0862</issn><issn>1942-0870</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>0YH</sourceid><sourceid>EIF</sourceid><sourceid>DOA</sourceid><recordid>eNp9Uk1v1DAQjRCIVqU_AZQjlyy249jOCVDFR6UiLnC2JvZ411USb20HtP8eh92u6AVfxnoz896M5lXVa0o2lCjyjvacESXYhhHWbhjtpRDqWXW54g1Rkjw__wW7qK5Tuifrk4RK8rK6aCXppGLqslq-QUp12qPJMUyY46EZIKGtp2XMvoGcox-WjHXJ7YKt_VzvY8hYYt5hhD0u2Zu0gnYxuX5YYPT5UE9h9jlEP29rmO0ZNmEuOuOr6oWDMeH1KV5VPz9_-nHztbn7_uX25uNdY7q2yw06a_gAyhmKHe2UANZZBQapQi5KjqpeYscE7QfFiRu4csicoLRzBolor6rbI68NcK_30U8QDzqA13-BELcaYpl_RC2V5JYNBKlp-UAYWOcop4NUrncwYOF6f-TaL8OE1mDZBMYnpE8zs9_pbfilKaGU9z0rDG9PDDE8LJiynnwyOI4wY1iSZoqUS0ou1sG7Y6mJIaWI7qxDiV4toB8toFcL6JMFSt-bf4c8dz0evBR8OBb42YU4we8QR6szHMYQXYTZ-KTb_2v8AfGAxTY</recordid><startdate>20231231</startdate><enddate>20231231</enddate><creator>Yang, Feng</creator><creator>Zhang, Jennifer</creator><creator>Buettner, Alexander</creator><creator>Vosika, Eva</creator><creator>Sadek, Monica</creator><creator>Hao, Zhiqi</creator><creator>Reusch, Dietmar</creator><creator>Koenig, Maximiliane</creator><creator>Chan, Wayman</creator><creator>Bathke, Anja</creator><creator>Pallat, Hilary</creator><creator>Lundin, Victor</creator><creator>Kepert, Jochen Felix</creator><creator>Bulau, Patrick</creator><creator>Deperalta, Galahad</creator><creator>Yu, Christopher</creator><creator>Beardsley, Richard</creator><creator>Camilli, Tura</creator><creator>Harris, Reed</creator><creator>Stults, John</creator><general>Taylor & Francis</general><general>Taylor & Francis Group</general><scope>0YH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20231231</creationdate><title>Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control</title><author>Yang, Feng ; Zhang, Jennifer ; Buettner, Alexander ; Vosika, Eva ; Sadek, Monica ; Hao, Zhiqi ; Reusch, Dietmar ; Koenig, Maximiliane ; Chan, Wayman ; Bathke, Anja ; Pallat, Hilary ; Lundin, Victor ; Kepert, Jochen Felix ; Bulau, Patrick ; Deperalta, Galahad ; Yu, Christopher ; Beardsley, Richard ; Camilli, Tura ; Harris, Reed ; Stults, John</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c535t-efdc4ba8fc1e51586a25d8ace18e46dc41897e52619b840fb48fe2f6115fce063</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antibodies, Monoclonal - chemistry</topic><topic>Biological Products</topic><topic>cGMP</topic><topic>Chromatography, Liquid - methods</topic><topic>GMP</topic><topic>Intact MAM</topic><topic>LC-MS</topic><topic>Mass Spectrometry - methods</topic><topic>MS in QC</topic><topic>multi-attribute method</topic><topic>new peak detection</topic><topic>product quality attribute</topic><topic>Quality Control</topic><topic>Review</topic><topic>targeted attribute quantitation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yang, Feng</creatorcontrib><creatorcontrib>Zhang, Jennifer</creatorcontrib><creatorcontrib>Buettner, Alexander</creatorcontrib><creatorcontrib>Vosika, Eva</creatorcontrib><creatorcontrib>Sadek, Monica</creatorcontrib><creatorcontrib>Hao, Zhiqi</creatorcontrib><creatorcontrib>Reusch, Dietmar</creatorcontrib><creatorcontrib>Koenig, Maximiliane</creatorcontrib><creatorcontrib>Chan, Wayman</creatorcontrib><creatorcontrib>Bathke, Anja</creatorcontrib><creatorcontrib>Pallat, Hilary</creatorcontrib><creatorcontrib>Lundin, Victor</creatorcontrib><creatorcontrib>Kepert, Jochen Felix</creatorcontrib><creatorcontrib>Bulau, Patrick</creatorcontrib><creatorcontrib>Deperalta, Galahad</creatorcontrib><creatorcontrib>Yu, Christopher</creatorcontrib><creatorcontrib>Beardsley, Richard</creatorcontrib><creatorcontrib>Camilli, Tura</creatorcontrib><creatorcontrib>Harris, Reed</creatorcontrib><creatorcontrib>Stults, John</creatorcontrib><collection>Taylor & Francis Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>mAbs</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yang, Feng</au><au>Zhang, Jennifer</au><au>Buettner, Alexander</au><au>Vosika, Eva</au><au>Sadek, Monica</au><au>Hao, Zhiqi</au><au>Reusch, Dietmar</au><au>Koenig, Maximiliane</au><au>Chan, Wayman</au><au>Bathke, Anja</au><au>Pallat, Hilary</au><au>Lundin, Victor</au><au>Kepert, Jochen Felix</au><au>Bulau, Patrick</au><au>Deperalta, Galahad</au><au>Yu, Christopher</au><au>Beardsley, Richard</au><au>Camilli, Tura</au><au>Harris, Reed</au><au>Stults, John</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control</atitle><jtitle>mAbs</jtitle><addtitle>MAbs</addtitle><date>2023-12-31</date><risdate>2023</risdate><volume>15</volume><issue>1</issue><spage>2197668</spage><epage>2197668</epage><pages>2197668-2197668</pages><issn>1942-0862</issn><eissn>1942-0870</eissn><abstract>The 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.</abstract><cop>United States</cop><pub>Taylor & Francis</pub><pmid>37057828</pmid><doi>10.1080/19420862.2023.2197668</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| source | Taylor & Francis Open Access; MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Antibodies, Monoclonal - chemistry Biological Products cGMP Chromatography, Liquid - methods GMP Intact MAM LC-MS Mass Spectrometry - methods MS in QC multi-attribute method new peak detection product quality attribute Quality Control Review targeted attribute quantitation |
| title | Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control |
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