{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T13:27:04Z","timestamp":1774618024996,"version":"3.50.1"},"reference-count":33,"publisher":"Public Library of Science (PLoS)","issue":"1","license":[{"start":{"date-parts":[[2022,1,27]],"date-time":"2022-01-27T00:00:00Z","timestamp":1643241600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001871","name":"funda\u00e7\u00e3o para a ci\u00eancia e a tecnologia","doi-asserted-by":"publisher","award":["iNOVA4Health \u2013UIDB\/Multi\/04462\/2020"],"award-info":[{"award-number":["iNOVA4Health \u2013UIDB\/Multi\/04462\/2020"]}],"id":[{"id":"10.13039\/501100001871","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013995","name":"Sanofi Genzyme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013995","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>Quality control of biopharmaceuticals such as monoclonal antibodies (mAbs) has been evolving and becoming more challenging as the requirements of the regulatory agencies increase due to the demanding complexity of products under evaluation. Mass Spectrometry (MS)-based methods such as the multi-attribute method (MAM) are being explored to achieve a deeper understanding of the attributes critical for the safety, efficacy, and quality of these products. MAM uses high mass accuracy\/high-resolution MS data that enables the direct and simultaneous monitoring of relevant product quality attributes (PQAs, in particular, chemical modifications) in a single workflow, replacing several orthogonal methods, reducing time and costs associated with these assays. Here we describe a MAM implementation process using a QTOF high resolution platform. Method implementation was accomplished using NIST (National Institute for Standards and Technology) mAb reference material and an in-process mAb sample. PQAs as glycosylation profiles, methionine oxidation, tryptophan dioxidation, asparagine deamidation, pyro-Glu at N-terminal and glycation were monitored. Focusing on applications that require batch analysis and high-throughput, sample preparation and LC-MS parameters troubleshooting are discussed. This MAM workflow was successfully explored as reference analytical tool for comprehensive characterization of a downstream processing (DSP) polishing platform and for a comparability study following technology transfer between different laboratories.<\/jats:p>","DOI":"10.1371\/journal.pone.0262711","type":"journal-article","created":{"date-parts":[[2022,1,27]],"date-time":"2022-01-27T18:38:15Z","timestamp":1643308695000},"page":"e0262711","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":26,"title":["Multi attribute method implementation using a High Resolution Mass Spectrometry platform: From sample preparation to batch analysis"],"prefix":"10.1371","volume":"17","author":[{"given":"Sofia B.","family":"Carvalho","sequence":"first","affiliation":[]},{"given":"Ricardo A.","family":"Gomes","sequence":"additional","affiliation":[]},{"given":"Anja","family":"Pfenninger","sequence":"additional","affiliation":[]},{"given":"Martina","family":"Fischer","sequence":"additional","affiliation":[]},{"given":"Michaela","family":"Strotbek","sequence":"additional","affiliation":[]},{"given":"In\u00eas A.","family":"Isidro","sequence":"additional","affiliation":[]},{"given":"Nihal","family":"Tug\u00e7u","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7245-6785","authenticated-orcid":true,"given":"Patr\u00edcia","family":"Gomes-Alves","sequence":"additional","affiliation":[]}],"member":"340","published-online":{"date-parts":[[2022,1,27]]},"reference":[{"key":"pone.0262711.ref001","article-title":"Establishment of a highly precise multi-attribute method for the characterization and quality control of therapeutic monoclonal antibodies.","author":"M Tajiri-Tsukada","year":"2020","journal-title":"Bioengineered"},{"key":"pone.0262711.ref002","article-title":"Antibodies to watch in 2020.","author":"H Kaplon","year":"2020","journal-title":"mAbs"},{"key":"pone.0262711.ref003","article-title":"Measurement of impurities to support process development and manufacture of biopharmaceuticals","author":"S Oshinbolu","year":"2018","journal-title":"TrAC\u2014Trends in Analytical Chemistry"},{"key":"pone.0262711.ref004","first-page":"651","article-title":"Monoclonal antibodies. 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