{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T15:58:34Z","timestamp":1775836714430,"version":"3.50.1"},"reference-count":34,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"published-print":{"date-parts":[[2026,8]]},"DOI":"10.1016\/j.jpba.2026.117461","type":"journal-article","created":{"date-parts":[[2026,3,14]],"date-time":"2026-03-14T03:10:30Z","timestamp":1773457830000},"page":"117461","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["A universal immunocapture LC\u2212MS\/MS method for humanized IgG1\u2212based drugs in cynomolgus monkeys"],"prefix":"10.1016","volume":"276","author":[{"given":"Pei","family":"Pang","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pingping","family":"Yin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yimin","family":"Tao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinchuan","family":"Hong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junjiu","family":"Xu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenhui","family":"Lin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiuping","family":"Qin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Likun","family":"Gong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"issue":"1","key":"10.1016\/j.jpba.2026.117461_bib1","doi-asserted-by":"crossref","DOI":"10.1080\/19420862.2024.2443538","article-title":"Antibodies to watch in 2025","volume":"17","author":"Crescioli","year":"2025","journal-title":"mAbs"},{"issue":"1","key":"10.1016\/j.jpba.2026.117461_bib2","doi-asserted-by":"crossref","DOI":"10.1080\/19420862.2022.2153410","article-title":"Antibodies to watch in 2023","volume":"15","author":"Kaplon","year":"2023","journal-title":"mAbs"},{"key":"10.1016\/j.jpba.2026.117461_bib3","doi-asserted-by":"crossref","DOI":"10.1016\/j.chroma.2024.465226","article-title":"Advances in analytical technologies for emerging drug modalities and their separation challenges in LC-MS systems","volume":"1732","author":"Malarvannan","year":"2024","journal-title":"J. Chromatogr. A"},{"issue":"6","key":"10.1016\/j.jpba.2026.117461_bib4","first-page":"960","article-title":"Tutorial on monographs: antibody pharmacokinetics and pharmacodynamics","volume":"103","author":"Ovacik","year":"2018","journal-title":"Clin. Pharmacol. Ther."},{"issue":"5","key":"10.1016\/j.jpba.2026.117461_bib5","doi-asserted-by":"crossref","first-page":"991","DOI":"10.1080\/19420862.2016.1167294","article-title":"Preclinical pharmacokinetics of MHAA4549A, a human monoclonal antibody to influenza A virus, and the prediction of its efficacious clinical dose for the treatment of patients hospitalized with influenza A","volume":"8","author":"Gupta","year":"2016","journal-title":"mAbs"},{"issue":"6","key":"10.1016\/j.jpba.2026.117461_bib6","doi-asserted-by":"crossref","first-page":"595","DOI":"10.3390\/pharmaceutics12060595","article-title":"Quantification of pharmacokinetic profiles of PD-1\/PD-L1 antibodies by validated ELISAs","volume":"12","author":"Zalba","year":"2020","journal-title":"Pharmaceutics"},{"issue":"3","key":"10.1016\/j.jpba.2026.117461_bib7","doi-asserted-by":"crossref","first-page":"572","DOI":"10.3390\/molecules29030572","article-title":"Development and validation of an ADA-tolerant assay for quantification of an exatecan-based ADC in monkey plasma","volume":"29","author":"Tao","year":"2024","journal-title":"Molecules"},{"key":"10.1016\/j.jpba.2026.117461_bib8","doi-asserted-by":"crossref","DOI":"10.1016\/j.vascn.2024.107580","article-title":"Ligand-binding assays validated for quantitative bioanalysis of a novel antibody-drug conjugate in monkey serum and related application in a nonclinical study","volume":"131","author":"Hou","year":"2025","journal-title":"J. Pharmacol. Toxicol. Methods"},{"issue":"15","key":"10.1016\/j.jpba.2026.117461_bib9","doi-asserted-by":"crossref","first-page":"941","DOI":"10.1080\/17576180.2025.2546709","article-title":"Overcoming target interference in bridging anti-drug antibody (ADA) assay by optimizing sample treatment","volume":"17","author":"Ye","year":"2025","journal-title":"Bioanalysis"},{"key":"10.1016\/j.jpba.2026.117461_bib10","unstructured":"U.S. Food and Drug Administration, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling: Content and Format, Draft Guidance for Industry, FDA, Silver Spring, MD, 2023."},{"issue":"4","key":"10.1016\/j.jpba.2026.117461_bib11","doi-asserted-by":"crossref","first-page":"117","DOI":"10.17145\/jab.16.016","article-title":"Detection of cynomolgus monkey anti-protein XYZ antibody using immunocapture-LC\/MS","volume":"2","author":"Roos","year":"2016","journal-title":"J. Appl. Bioanal."},{"issue":"8","key":"10.1016\/j.jpba.2026.117461_bib12","first-page":"1024","article-title":"A universal surrogate peptide to enable LC-MS\/MS bioanalysis of a diversity of human monoclonal antibody and human Fc-fusion protein drug candidates in pre-clinical animal studies","volume":"26","author":"Furlong","year":"2012"},{"issue":"7","key":"10.1016\/j.jpba.2026.117461_bib13","doi-asserted-by":"crossref","first-page":"165","DOI":"10.4155\/bio-2023-0261","article-title":"Immunocapture LC-MS methods for pharmacokinetics of large molecule drugs","volume":"16","author":"Werth","year":"2024","journal-title":"Bioanalysis"},{"issue":"1","key":"10.1016\/j.jpba.2026.117461_bib14","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1038\/nmeth.2309","article-title":"Quantitative analysis of peptides and proteins in biomedicine by targeted mass spectrometry","volume":"10","author":"Gillette","year":"2013","journal-title":"Nat. Methods"},{"issue":"1","key":"10.1016\/j.jpba.2026.117461_bib15","doi-asserted-by":"crossref","first-page":"27728","DOI":"10.1038\/s41598-025-13396-3","article-title":"LC-MS\/MS quantification of omadacycline in human plasma for therapeutic drug monitoring: method development and clinical application","volume":"15","author":"Wang","year":"2025","journal-title":"Sci. Rep."},{"issue":"3","key":"10.1016\/j.jpba.2026.117461_bib16","doi-asserted-by":"crossref","first-page":"747","DOI":"10.1039\/D0AN01963A","article-title":"Multi-dimensional LC-MS: the next generation characterization of antibody-based therapeutics by unified online bottom-up, middle-up and intact approaches","volume":"146","author":"Camperi","year":"2021","journal-title":"Analyst"},{"issue":"10","key":"10.1016\/j.jpba.2026.117461_bib17","doi-asserted-by":"crossref","first-page":"5989","DOI":"10.1021\/acs.analchem.8b00694","article-title":"A two-step immunocapture LC-MS\/MS assay for plasma stability and payload migration assessment of cysteine\u2013maleimide-based antibody drug conjugates","volume":"90","author":"Dong","year":"2018","journal-title":"Anal. Chem."},{"issue":"1","key":"10.1016\/j.jpba.2026.117461_bib18","doi-asserted-by":"crossref","DOI":"10.1080\/19420862.2023.2191302","article-title":"Impact of IgG subclass on monoclonal antibody developability","volume":"15","author":"Cain","year":"2023","journal-title":"mAbs"},{"issue":"6","key":"10.1016\/j.jpba.2026.117461_bib19","doi-asserted-by":"crossref","first-page":"1687","DOI":"10.1007\/s00216-015-9286-x","article-title":"The use of generic surrogate peptides for the quantitative analysis of human immunoglobulin G1 in pre-clinical species with high-resolution mass spectrometry","volume":"408","author":"Lanshoeft","year":"2016","journal-title":"Anal. Bioanal. Chem."},{"key":"10.1016\/j.jpba.2026.117461_bib20","series-title":"ICH guideline M10 on bioanalytical method validation and study sample analysis","author":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)","year":"2022"},{"key":"10.1016\/j.jpba.2026.117461_bib21","series-title":"Guideline on Bioanalytical Method Validation","author":"European Medicines Agency (EMA)","year":"2012"},{"key":"10.1016\/j.jpba.2026.117461_bib22","doi-asserted-by":"crossref","DOI":"10.1016\/j.jchromb.2023.123904","article-title":"Tutorial review for peptide assays: An ounce of pre-analytics is worth a pound of cure","volume":"1229","author":"Maurer","year":"2023","journal-title":"J. Chromatogr. B"},{"key":"10.1016\/j.jpba.2026.117461_bib23","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.chroma.2014.06.072","article-title":"Strategies to reduce aspecific adsorption of peptides and proteins in liquid chromatography-mass spectrometry based bioanalyses: an overview","volume":"1358","author":"Maes","year":"2014","journal-title":"J. Chromatogr. A"},{"issue":"1","key":"10.1016\/j.jpba.2026.117461_bib24","doi-asserted-by":"crossref","first-page":"3","DOI":"10.3390\/antib14010003","article-title":"Challenges and insights in absolute quantification of recombinant therapeutic antibodies by mass spectrometry: an introductory review","volume":"14","author":"D\u00f6ring","year":"2025","journal-title":"Antibodies"},{"issue":"7","key":"10.1016\/j.jpba.2026.117461_bib25","doi-asserted-by":"crossref","first-page":"629","DOI":"10.4155\/bio-2019-0032","article-title":"Protein quantification by LC-MS: a decade of progress through the pages of Bioanalysis","volume":"11","author":"van de Merbel","year":"2019","journal-title":"Bioanalysis"},{"issue":"11","key":"10.1016\/j.jpba.2026.117461_bib26","doi-asserted-by":"crossref","first-page":"1858","DOI":"10.1124\/dmd.114.058917","article-title":"Toward sensitive and accurate analysis of antibody biotherapeutics by liquid chromatography coupled with mass spectrometry","volume":"42","author":"An","year":"2014","journal-title":"Drug Metab. Dispos."},{"issue":"11","key":"10.1016\/j.jpba.2026.117461_bib27","doi-asserted-by":"crossref","first-page":"1389","DOI":"10.4155\/bio.15.69","article-title":"Bioanalytical method validation considerations for LC-MS\/MS assays of therapeutic proteins","volume":"7","author":"Duggan","year":"2015","journal-title":"Bioanalysis"},{"issue":"15","key":"10.1016\/j.jpba.2026.117461_bib28","doi-asserted-by":"crossref","first-page":"1565","DOI":"10.4155\/bio-2016-0117","article-title":"Validation of a biotherapeutic immunoaffinity-LC-MS\/MS assay in monkey serum: 'plug-and-play' across seven molecules","volume":"8","author":"Kaur","year":"2016","journal-title":"Bioanalysis"},{"issue":"1-2","key":"10.1016\/j.jpba.2026.117461_bib29","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1016\/j.jim.2005.06.014","article-title":"An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen","volume":"304","author":"Patton","year":"2005","journal-title":"J. Immunol. Methods"},{"key":"10.1016\/j.jpba.2026.117461_bib30","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1016\/j.jim.2016.02.008","article-title":"Affinity capture elution bridging assay: a novel immunoassay format for detection of anti-therapeutic protein antibodies","volume":"431","author":"Chen","year":"2016","journal-title":"J. Immunol. Methods"},{"issue":"3","key":"10.1016\/j.jpba.2026.117461_bib31","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1016\/j.yrtph.2007.07.005","article-title":"Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA","volume":"49","author":"Smith","year":"2007","journal-title":"Regul. Toxicol. Pharm."},{"key":"10.1016\/j.jpba.2026.117461_bib32","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2022.115188","article-title":"Development and validation of an LC-MS\/MS method for quantitation of recombinant human growth hormone in rat plasma and application to a pharmacokinetic study","volume":"224","author":"Huang","year":"2023","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jpba.2026.117461_bib33","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2024.116083","article-title":"A validated LC-MS\/MS method for the quantitation of daratumumab in rat serum using rapid tryptic digestion without IgG purification and reduction","volume":"243","author":"Li","year":"2024","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jpba.2026.117461_bib34","doi-asserted-by":"crossref","DOI":"10.1016\/j.jchromb.2023.123844","article-title":"Development and validation of a hybrid immunoaffinity LC-MS\/MS assay for quantitation of total antibody (TAb) from an antibody drug conjugate (ADC) PYX-201 in human plasma","volume":"1228","author":"Yin","year":"2023","journal-title":"J. Chromatogr. B Anal. Technol. Biomed. Life Sci."}],"container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708526001299?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708526001299?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T15:26:03Z","timestamp":1775834763000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0731708526001299"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":34,"alternative-id":["S0731708526001299"],"URL":"https:\/\/doi.org\/10.1016\/j.jpba.2026.117461","relation":{},"ISSN":["0731-7085"],"issn-type":[{"value":"0731-7085","type":"print"}],"subject":[],"published":{"date-parts":[[2026,8]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"A universal immunocapture LC\u2212MS\/MS method for humanized IgG1\u2212based drugs in cynomolgus monkeys","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical and Biomedical Analysis","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jpba.2026.117461","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"117461"}}