{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,18]],"date-time":"2026-01-18T03:50:20Z","timestamp":1768708220327,"version":"3.49.0"},"reference-count":20,"publisher":"Wiley","issue":"14","license":[{"start":{"date-parts":[[2017,6,18]],"date-time":"2017-06-18T00:00:00Z","timestamp":1497744000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Rapid Comm Mass Spectrometry"],"published-print":{"date-parts":[[2017,7,30]]},"abstract":"\n Rationale<\/jats:title>\n \n Because of the large molecular weight, the structural complexity and the similarity with endogenous immunoglobulins present in high concentrations,\n in vivo<\/jats:italic>\n quantitative studies with therapeutic monoclonal antibodies are particularly challenging. In this work, an UPLC\/MRM MS\u2010based methodology is described for the quantification of trastuzumab in human serum by monitoring a novel specific peptide marker located within its heavy chain Complementarity\u2010Determining Region (CDR).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n For maximum sensitivity and selectivity, specific transitions of this diagnostic proteotypic peptide were optimized and monitored at\n m\/z<\/jats:italic>\n 364.1\u00a0\u2192\u00a0437.3 (quantitation ion) and\n m\/z<\/jats:italic>\n 364.1\u00a0\u2192\u00a0358.0 (confirmation ion). As a proof\u2010of\u2010concept, the methodology was applied to the determination of trastuzumab in human serum over a clinically relevant range from 0.02 to 200\u00a0\u03bcg\/mL. The methodology has been evaluated in terms of specificity, linearity, accuracy, precision, detection and quantitation limits.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n An excellent linear response has been obtained in the range from 0.036 to 3.6 fmol\/\u03bcL for the standard peptide and from 0.03 to 285 fmol\/\u03bcL for the trastuzumab in human serum with typical R\n 2<\/jats:sup>\n values of 0.99. The limit of detection (LOD) and limit of quantification (LOQ) are 0.005 fmol\/\u03bcL and 0.05 fmol\/\u03bcL, respectively, with mean bias and RSD values of 18% and 1%, respectively, for quality control samples.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The strategy used to set up the UPLC\/MRM MS methodology based on monitoring specific peptide markers within CDRs can be potentially applied to the detection and quantification of other humanized or human mAbs in biological fluids. Copyright \u00a9 2017 John Wiley & Sons, Ltd.<\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/rcm.7898","type":"journal-article","created":{"date-parts":[[2017,5,10]],"date-time":"2017-05-10T06:13:04Z","timestamp":1494396784000},"page":"1184-1192","source":"Crossref","is-referenced-by-count":18,"title":["Ultra\u2010performance liquid chromatography\/multiple reaction monitoring mass spectrometry quantification of trastuzumab in human serum by selective monitoring of a specific peptide marker from the antibody complementarity\u2010determining regions"],"prefix":"10.1002","volume":"31","author":[{"given":"R.","family":"Russo","sequence":"first","affiliation":[{"name":"Department of Environmental, Biological and Pharmaceutical Sciences and Technologies University of Campania 'Luigi Vanvitelli' 81100 Caserta Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Rega","sequence":"additional","affiliation":[{"name":"Department of Environmental, Biological and Pharmaceutical Sciences and Technologies University of Campania 'Luigi Vanvitelli' 81100 Caserta Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Caporale","sequence":"additional","affiliation":[{"name":"CNR\u2010IBB 80134 Napoli Italy"},{"name":"CIRPeB, University of Naples 'Federico II' 80134 Napoli Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G.","family":"Tonon","sequence":"additional","affiliation":[{"name":"Bioker Multimedica 80142 Napoli Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Scaramuzza","sequence":"additional","affiliation":[{"name":"Bioker Multimedica 80142 Napoli Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F.","family":"Selis","sequence":"additional","affiliation":[{"name":"Bioker Multimedica 80142 Napoli Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Ruvo","sequence":"additional","affiliation":[{"name":"CNR\u2010IBB 80134 Napoli Italy"},{"name":"CIRPeB, University of Naples 'Federico II' 80134 Napoli Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5136-0941","authenticated-orcid":false,"given":"A.","family":"Chambery","sequence":"additional","affiliation":[{"name":"Department of Environmental, Biological and Pharmaceutical Sciences and Technologies University of Campania 'Luigi Vanvitelli' 81100 Caserta Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,6,18]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd984"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2008.170"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200103153441110"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.2174\/157488408783329931"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00216-014-7842-4"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2004.09.012"},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2010.11.003"},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1124619"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.febslet.2013.11.027"},{"key":"e_1_2_5_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/mas.20190"},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2007.11.002"},{"key":"e_1_2_5_13_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.analchem.5b04276"},{"key":"e_1_2_5_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.3606"},{"key":"e_1_2_5_15_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms17040491"},{"key":"e_1_2_5_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1399-3011.1990.tb00939.x"},{"key":"e_1_2_5_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02538384"},{"key":"e_1_2_5_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/pro.5560041120"},{"key":"e_1_2_5_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00726-014-1681-7"},{"key":"e_1_2_5_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrc3236"},{"key":"e_1_2_5_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.critrevonc.2004.10.011"}],"container-title":["Rapid 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