{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T09:40:32Z","timestamp":1775554832128,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,12,7]],"date-time":"2025-12-07T00:00:00Z","timestamp":1765065600000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Separation Science"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Monoclonal antibodies are biopharmaceuticals used to treat various diseases, including autoimmune disorders and cancer. Due to their structural complexity and inherent heterogeneity, robust analytical methods are required for their accurate quantification and quality control. This study presents a novel middle\u2010up (MU) capillary zone electrophoresis\u2010mass spectrometry (CZE\u2010MS) method for the quantitative analysis of infliximab (IFX), a widely used therapeutic mAb. The method relies on disulfide bond reduction to separate heavy and light chains, followed by CZE separation using a 2\u00a0M acetic acid background electrolyte and MS detection in single ion monitoring mode. Adalimumab was used as an internal standard, providing a suitable alternative to isotopically labeled monoclonal antibody analogues. Evaluation of the analytical method performance followed ICH Q2(R1) guidelines and demonstrated an acceptable linearity range (4\u201335\u00a0\u00b5g\/mL), precision, accuracy, and a limit of quantification of 4\u00a0\u00b5g\/mL. The method was successfully applied to quantify IFX in a commercial pharmaceutical (Remicade). Moreover, the method was preliminarily tested for the quality control of bevacizumab in Avastin and rituximab in MabThera pharmaceutical formulations. To our knowledge, this is the first report of quantitative MU CZE\u2010MS analysis of therapeutic monoclonal antibodies directly from pharmaceutical matrices, highlighting its potential for quality drug control applications.<\/jats:p>","DOI":"10.1002\/jssc.70335","type":"journal-article","created":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T06:44:57Z","timestamp":1765176297000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Quantification of Monoclonal Antibodies in Pharmaceutical Matrices by Middle\u2010Up Capillary Zone Electrophoresis\u2010Mass Spectrometry"],"prefix":"10.1002","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7557-4733","authenticated-orcid":false,"given":"Jana","family":"Havlikova","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Analysis and Nuclear Pharmacy Faculty of Pharmacy Comenius University Bratislava  Bratislava Slovakia"},{"name":"Toxicology and Antidoping Centre Faculty of Pharmacy Comenius University Bratislava  Bratislava Slovakia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2170-6582","authenticated-orcid":false,"given":"Katarina","family":"Marakova","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis and Nuclear Pharmacy Faculty of Pharmacy Comenius University Bratislava  Bratislava Slovakia"},{"name":"Toxicology and Antidoping Centre Faculty of Pharmacy Comenius University Bratislava  Bratislava Slovakia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5755-9970","authenticated-orcid":false,"given":"Peter","family":"Mikus","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis and Nuclear Pharmacy Faculty of Pharmacy Comenius University Bratislava  Bratislava Slovakia"},{"name":"Toxicology and Antidoping Centre Faculty of Pharmacy Comenius University Bratislava  Bratislava Slovakia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,12,7]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2023.110376"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.4314\/tjpr.v16i3.29"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/abt\/tbac021"},{"key":"e_1_2_8_5_1","unstructured":"\u201cAntibody Therapeutics Approved or in Regulatory Review in the EU or US \u201dAntibody Society accessed January 28 2025 https:\/\/www.antibodysociety.org\/resources\/approved\u2010antibodies\/."},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2021.114330"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/antib8010018"},{"key":"e_1_2_8_8_1","doi-asserted-by":"crossref","unstructured":"D. R.Cunha M. B.Quinaz andM. A.Segundo \u201cBiopharmaceutical Analysis\u2014Current Analytical Challenges Limitations and Perspectives \u201dAnalytical and Bioanalytical Chemistry ahead of print August 12 2025 https:\/\/doi.org\/10.1007\/s00216\u2010025\u201006036\u20102.","DOI":"10.1007\/s00216-025-06036-2"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph16020291"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/elps.202100182"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jproteome.3c00416"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43586\u2010024\u201000318\u20102"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13361\u2010019\u201002201\u2010x"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.analchem.6b00544"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13361\u2010016\u20101566\u2010y"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1515\/cclm\u20102019\u20100862"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2022.462840"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1039\/D4AY00404C"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/elps.201800331"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trac.2021.116407"},{"key":"e_1_2_8_21_1","unstructured":"\u201cDetailed View of Infliximab CRS \u201dReference Substances accessed September 2 2024 https:\/\/crs.edqm.eu\/db\/4DCGI\/View=Y0002047."},{"key":"e_1_2_8_22_1","volume-title":"Validation of Analytical Procedures: Text and Methodology Q2(R1)","author":"The International","year":"2005"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/elps.202300089"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2024.464697"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13361\u2010017\u20101696\u2010x"}],"container-title":["Journal of Separation Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jssc.70335","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,11]],"date-time":"2026-01-11T18:01:09Z","timestamp":1768154469000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/jssc.70335"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12]]},"references-count":24,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/jssc.70335"],"URL":"https:\/\/doi.org\/10.1002\/jssc.70335","archive":["Portico"],"relation":{},"ISSN":["1615-9306","1615-9314"],"issn-type":[{"value":"1615-9306","type":"print"},{"value":"1615-9314","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12]]},"assertion":[{"value":"2025-07-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-27","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-07","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70335"}}