{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T03:53:59Z","timestamp":1781754839666,"version":"3.54.5"},"reference-count":32,"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":[[2026,4,29]],"date-time":"2026-04-29T00:00:00Z","timestamp":1777420800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009945","name":"Merck KGaA","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009945","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["European Journal of Pharmaceutical Sciences"],"published-print":{"date-parts":[[2026,8]]},"DOI":"10.1016\/j.ejps.2026.107540","type":"journal-article","created":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T16:43:07Z","timestamp":1777567387000},"page":"107540","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Development and validation of a semi-automated hybrid immunocapture liquid chromatography-mass spectrometry method to quantify LALA-mutated biotherapeutics in mouse plasma"],"prefix":"10.1016","volume":"223","author":[{"given":"Vittoria","family":"Papa","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilse","family":"De Salve","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Molinaro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea Di","family":"Ianni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Monge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Mastroianni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Ariaudo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrizia","family":"Tavano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valeria","family":"Castagna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyra","family":"Cowan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico Riccardi","family":"Sirtori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"Suppl 1","key":"10.1016\/j.ejps.2026.107540_bib0001","article-title":"1190 A novel \u20182+1\u2019 bispecific T cell engager platform, enables enhanced anti-tumor activity with reduced risk of CRS","volume":"11","year":"2023","journal-title":"J. ImmunOther Cancer"},{"issue":"1","key":"10.1016\/j.ejps.2026.107540_bib0002","doi-asserted-by":"crossref","DOI":"10.1080\/19420862.2025.2465391","article-title":"Combinatorial Fc modifications for complementary antibody functionality","volume":"17","author":"Bartsch","year":"2025","journal-title":"MAbs."},{"key":"10.1016\/j.ejps.2026.107540_bib0003","doi-asserted-by":"crossref","unstructured":"Boross P, Peipp M, Nimmerjahn F. Effector functions of therapeutic antibodies. Editorial. 2023;1\u20133.","DOI":"10.3389\/978-2-83251-472-6"},{"issue":"1","key":"10.1016\/j.ejps.2026.107540_bib0004","doi-asserted-by":"crossref","DOI":"10.1080\/19420862.2025.2505092","article-title":"Impact of antibody Fc engineering on translational pharmacology and safety: insights from industry case studies","volume":"17","author":"Brennan","year":"2025","journal-title":"MAbs."},{"issue":"1","key":"10.1016\/j.ejps.2026.107540_bib0005","first-page":"1","article-title":"Advanced treatment of type 1 diabetes with Teplizumab: mechanism and clinical efficacy","volume":"8","author":"Chavan","year":"2025","journal-title":"Asian J. Med. Princ. Clin. Pract."},{"key":"10.1016\/j.ejps.2026.107540_bib0006","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1016\/j.sbi.2016.07.012","article-title":"Engineering antibody therapeutics","volume":"38","author":"Chiu","year":"2016","journal-title":"Curr. Opin. Struct. Biol."},{"issue":"1","key":"10.1016\/j.ejps.2026.107540_bib0007","doi-asserted-by":"crossref","DOI":"10.1080\/19420862.2025.2453515","article-title":"With great power, comes great responsibility: the importance of broadly measuring fc-mediated effector function early in the antibody development process","volume":"17","author":"Crescioli","year":"2025","journal-title":"MAbs"},{"issue":"1","key":"10.1016\/j.ejps.2026.107540_bib0008","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1208\/s12248-014-9682-8","article-title":"Emerging technologies to increase ligand binding assay sensitivity","volume":"17","author":"Fischer","year":"2015","journal-title":"AAPS. J."},{"issue":"2","key":"10.1016\/j.ejps.2026.107540_bib0009","doi-asserted-by":"crossref","DOI":"10.1002\/jmv.29430","article-title":"Cross-reaction mediated by distinct key amino acid combinations in the complementary-determining region (CDR) of a monoclonal antibody","volume":"96","author":"Guo","year":"2024","journal-title":"J. Med. Virol."},{"issue":"1","key":"10.1016\/j.ejps.2026.107540_bib0010","doi-asserted-by":"crossref","first-page":"422","DOI":"10.1111\/imr.13379","article-title":"Living in LALA land? Forty years of attenuating Fc effector functions","volume":"328","author":"Hale","year":"2024","journal-title":"Immunol. Rev."},{"issue":"12","key":"10.1016\/j.ejps.2026.107540_bib0011","doi-asserted-by":"crossref","first-page":"817","DOI":"10.1080\/17576180.2025.2529149","article-title":"Liquid chromatography\u2013tandem mass spectrometry methods for clinical quantitation of antibiotics","volume":"17","author":"He","year":"2025","journal-title":"Bioanalysis"},{"issue":"20","key":"10.1016\/j.ejps.2026.107540_bib0012","article-title":"Mimicking lighting-induced electrochemistry on the early Earth","volume":"114","author":"Jiang","year":"2017","journal-title":"Proc. Natl. Acad. Sci. u S. a"},{"issue":"9","key":"10.1016\/j.ejps.2026.107540_bib0013","doi-asserted-by":"crossref","first-page":"505","DOI":"10.4155\/bio-2022-0078","article-title":"2021 white paper on recent issues in bioanalysis: mass spec of proteins, extracellular vesicles, CRISPR, chiral assays, oligos","volume":"14","author":"Kaur","year":"2022","journal-title":"Bioanalysis"},{"issue":"5","key":"10.1016\/j.ejps.2026.107540_bib0014","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1007\/s40265-023-01847-y","article-title":"Teplizumab: first approval","volume":"83","author":"Keam","year":"2023","journal-title":"Drugs"},{"key":"10.1016\/j.ejps.2026.107540_bib0015","series-title":"Biosystems, Biomedical & Drug Delivery Systems: Characterization, Restoration and Optimization","author":"Kulkarni","year":"2024"},{"key":"10.1016\/j.ejps.2026.107540_bib0016","article-title":"Antibody-drug conjugates in triple-negative breast cancer (2010\u20132024): a bibliometric analysis of global trends and clinical translation","author":"Li","year":"2025","journal-title":"Discover Oncol."},{"issue":"1","key":"10.1016\/j.ejps.2026.107540_bib0017","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1007\/s13238-017-0408-4","article-title":"Pharmacokinetics of monoclonal antibodies and Fc-fusion proteins","volume":"9","author":"Liu","year":"2018","journal-title":"Protein Cell"},{"issue":"4","key":"10.1016\/j.ejps.2026.107540_bib0018","article-title":"Fc-engineering for modulated effector functions\u2014Improving antibodies for cancer treatment","volume":"9","author":"Liu","year":"2020","journal-title":"Antibodies (Basel)"},{"issue":"8","key":"10.1016\/j.ejps.2026.107540_bib0019","doi-asserted-by":"crossref","first-page":"2657","DOI":"10.4049\/jimmunol.147.8.2657","article-title":"Human fc gamma RI and fc gamma RII interact with distinct but overlapping sites on human IgG","volume":"147","author":"Lund","year":"1991","journal-title":"J. Immunol."},{"issue":"2","key":"10.1016\/j.ejps.2026.107540_bib0020","first-page":"122","article-title":"Tandem mass spectrometry (LC-MS-MS): a predominant role in bioassays for pharmacokinetic studies","volume":"57","author":"Marzo","year":"2007","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.ejps.2026.107540_bib0021","series-title":"bioRxiv preprint","article-title":"Generation and therapeutic efficacy of novel Fc-modified cross-neutralizing human monoclonal antibodies against dengue virus","author":"Mongkut","year":"2023"},{"issue":"4","key":"10.1016\/j.ejps.2026.107540_bib0022","doi-asserted-by":"crossref","first-page":"203","DOI":"10.4155\/bio-2020-0324","article-title":"2020 white paper on recent issues in bioanalysis: BMV of hybrid assays, acoustic MS, HRMS, data integrity, endogenous compounds, microsampling and microbiome (Part 1\u2014recommendations on industry\/regulators consensus on BMV of bioth)","volume":"13","author":"Neubert","year":"2021","journal-title":"Bioanalysis"},{"issue":"23","key":"10.1016\/j.ejps.2026.107540_bib0023","doi-asserted-by":"crossref","first-page":"1897","DOI":"10.4155\/bio-2018-0285","article-title":"2018 white paper on recent issues in bioanalysis: focus on immunogenicity assays by hybrid LBA\/LC-MS and regulatory feedback part 2\u2014PK, PD & ADA assays by hybrid LBA\/LC-MS & regulatory agencies\u2019 inputs on bioanalysis, biomarkers and immunogenicity","volume":"10","author":"Neubert","year":"2018","journal-title":"Bioanalysis"},{"issue":"00","key":"10.1016\/j.ejps.2026.107540_bib0024","first-page":"1","article-title":"Evolving bioanalytical strategies in the wake of pioneering biotherapeutics","volume":"00","author":"Riccardi","year":"2025","journal-title":"Bioanalysis"},{"key":"10.1016\/j.ejps.2026.107540_bib0025","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3389\/fimmu.2019.01296","article-title":"Conceptual approaches to modulating antibody effector functions and circulation half-life","volume":"10","author":"Saunders","year":"2019","journal-title":"Front. Immunol."},{"issue":"2 Suppl 2","key":"10.1016\/j.ejps.2026.107540_bib0026","doi-asserted-by":"crossref","first-page":"S41","DOI":"10.1016\/j.jaci.2009.09.046","article-title":"Structure and function of immunoglobulins","volume":"125","author":"Schroeder","year":"2010","journal-title":"J. Allergy Clin. Immunol."},{"issue":"1","key":"10.1016\/j.ejps.2026.107540_bib0027","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1007\/s13238-017-0457-8","article-title":"Current progress in innovative engineered antibodies","volume":"9","author":"Strohl","year":"2018","journal-title":"Protein Cell"},{"issue":"16_suppl","key":"10.1016\/j.ejps.2026.107540_bib0028","doi-asserted-by":"crossref","DOI":"10.1200\/JCO.2023.41.16_suppl.2531","article-title":"A phase 1 dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors","volume":"43","author":"Tolcher","year":"2025","journal-title":"J. Clin. Oncol."},{"issue":"5","key":"10.1016\/j.ejps.2026.107540_bib0029","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1208\/s12248-024-00974-y","article-title":"ICH M10 bioanalytical method validation guideline\u20141 year later","volume":"26","author":"Vazvaei-Smith","year":"2024","journal-title":"AAPS. J."},{"issue":"11","key":"10.1016\/j.ejps.2026.107540_bib0030","doi-asserted-by":"crossref","first-page":"1685","DOI":"10.1158\/1535-7163.MCT-25-0254","article-title":"TUB-040, a homogeneous and hydrophilic NaPi2b-targeting ADC with stably linked exatecan, exhibits long-lasting antitumor activity and a well-tolerated safety profile","volume":"24","author":"Vogl","year":"2024","journal-title":"Mol. Cancer Ther."},{"issue":"1","key":"10.1016\/j.ejps.2026.107540_bib0031","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1007\/s13238-017-0473-8","article-title":"IgG fc engineering to modulate antibody effector functions","volume":"9","author":"Wang","year":"2018","journal-title":"Protein Cell"},{"issue":"12","key":"10.1016\/j.ejps.2026.107540_bib0032","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0260954","article-title":"Fc-engineered antibodies with immune effector functions completely abolished","volume":"16","author":"Wilkinson","year":"2021","journal-title":"PLoS. One"}],"container-title":["European Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0928098726001144?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0928098726001144?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T03:14:51Z","timestamp":1781752491000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0928098726001144"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":32,"alternative-id":["S0928098726001144"],"URL":"https:\/\/doi.org\/10.1016\/j.ejps.2026.107540","relation":{},"ISSN":["0928-0987"],"issn-type":[{"value":"0928-0987","type":"print"}],"subject":[],"published":{"date-parts":[[2026,8]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Development and validation of a semi-automated hybrid immunocapture liquid chromatography-mass spectrometry method to quantify LALA-mutated biotherapeutics in mouse plasma","name":"articletitle","label":"Article Title"},{"value":"European Journal of Pharmaceutical Sciences","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.ejps.2026.107540","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Author(s). Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"107540"}}