{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T05:33:11Z","timestamp":1793338391806,"version":"4.5.0"},"reference-count":29,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"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 Controlled Release"],"published-print":{"date-parts":[[2026,11]]},"DOI":"10.1016\/j.jconrel.2026.115308","type":"journal-article","created":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T15:56:18Z","timestamp":1787673378000},"page":"115308","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"PA","title":["Effect of berahyaluronidase alfa on subcutaneous absorption and local tolerability of ALT-P7, an antibody-drug conjugate in preclinical studies"],"prefix":"10.1016","volume":"399","author":[{"given":"Woohyung","family":"Jung","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Woojin","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eun Mee","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seongwon","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soon-Jae","family":"Park","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunbae","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji-Sun","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"So Hyeon","family":"Seo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min Jung","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Woo-Chan","family":"Son","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tae Hwan","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.jconrel.2026.115308_bb0005","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1007\/s40259-018-0295-0","article-title":"Subcutaneous administration of biotherapeutics: an overview of current challenges and opportunities","volume":"32","author":"Bittner","year":"2018","journal-title":"BioDrugs"},{"key":"10.1016\/j.jconrel.2026.115308_bb0010","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1016\/j.jconrel.2020.02.036","article-title":"Accelerating the development of novel technologies and tools for the subcutaneous delivery of biotherapeutics","volume":"321","author":"Collins","year":"2020","journal-title":"J. Control. Release"},{"key":"10.1016\/j.jconrel.2026.115308_bb0015","doi-asserted-by":"crossref","first-page":"422","DOI":"10.1002\/cpt.3150","article-title":"Subcutaneous administration of monoclonal antibodies: pharmacology, delivery, immunogenicity, and learnings from applications to clinical development","volume":"115","author":"Davis","year":"2024","journal-title":"Clin. Pharmacol. Ther."},{"key":"10.1016\/j.jconrel.2026.115308_bb0020","doi-asserted-by":"crossref","first-page":"159","DOI":"10.2147\/DDDT.S287323","article-title":"Subcutaneous delivery of high-dose\/volume biologics: current status and prospect for future advancements","volume":"15","author":"Badkar","year":"2021","journal-title":"Drug Des Dev Ther"},{"key":"10.1016\/j.jconrel.2026.115308_bb0025","doi-asserted-by":"crossref","first-page":"2285277","DOI":"10.1080\/19420862.2023.2285277","article-title":"Monoclonal antibody and protein therapeutic formulations for subcutaneous delivery: high-concentration, low-volume vs. low-concentration, high-volume","volume":"15","author":"Desai","year":"2023","journal-title":"mAbs"},{"key":"10.1016\/j.jconrel.2026.115308_bb0030","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1208\/s12248-012-9367-0","article-title":"Mechanistic determinants of biotherapeutics absorption following SC injection","volume":"14","author":"Richter","year":"2012","journal-title":"AAPS J."},{"key":"10.1016\/j.jconrel.2026.115308_bb0035","doi-asserted-by":"crossref","first-page":"655","DOI":"10.1080\/17425247.2019.1568408","article-title":"Subcutaneous delivery of biotherapeutics: challenges at the injection site","volume":"16","author":"Sequeira","year":"2019","journal-title":"Expert Opin. Drug Deliv."},{"key":"10.1016\/j.jconrel.2026.115308_bb0040","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1080\/10717544.2018.1551442","article-title":"ENHANZE\u00ae drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase PH20","volume":"26","author":"Locke","year":"2019","journal-title":"Drug Deliv."},{"issue":"1","key":"10.1016\/j.jconrel.2026.115308_bb0045","doi-asserted-by":"crossref","DOI":"10.1080\/19420862.2024.2402713","article-title":"Navigating large-volume subcutaneous injections of biopharmaceuticals: a systematic review of clinical pipelines and approved products","volume":"16","author":"Green","year":"2024","journal-title":"MAbs"},{"key":"10.1016\/j.jconrel.2026.115308_bb0050","doi-asserted-by":"crossref","first-page":"775","DOI":"10.1016\/j.annonc.2025.03.012","article-title":"Subcutaneous versus intravenous pembrolizumab, in combination with chemotherapy, for treatment of metastatic non-small-cell lung cancer: the phase III 3475A-D77 trial","volume":"36","author":"Felip","year":"2025","journal-title":"Ann. Oncol."},{"key":"10.1016\/j.jconrel.2026.115308_bb0055","series-title":"FDA Approves Pembrolizumab and Berahyaluronidase Alfa-pmph for Subcutaneous Injection","author":"FDA","year":"2025"},{"key":"10.1016\/j.jconrel.2026.115308_bb0060","doi-asserted-by":"crossref","DOI":"10.1007\/s40495-026-00442-5","article-title":"Subcutaneous delivery of antibody-drug conjugates: opportunities and challenges","volume":"12","author":"Yaseen","year":"2026","journal-title":"Curr. Pharmacol. Rep."},{"key":"10.1016\/j.jconrel.2026.115308_bb0065","doi-asserted-by":"crossref","DOI":"10.3390\/pharmaceutics15041132","article-title":"Pharmacokinetics and pharmacodynamics of antibody-drug conjugates administered via subcutaneous and intratumoral routes","volume":"15","author":"Chang","year":"2023","journal-title":"Pharmaceutics"},{"key":"10.1016\/j.jconrel.2026.115308_bb0070","doi-asserted-by":"crossref","first-page":"832","DOI":"10.1111\/jcpt.13148","article-title":"Extravasation of an antibody-drug conjugate: a case report of epidermal necrosis after trastuzumab-emtansine extravasation","volume":"45","author":"Sallevelt","year":"2020","journal-title":"J. Clin. Pharm. Ther."},{"key":"10.1016\/j.jconrel.2026.115308_bb0075","doi-asserted-by":"crossref","DOI":"10.1007\/s13346-026-02144-3","article-title":"Enhanced subcutaneous delivery of antibody-drug conjugates with recombinant human hyaluronidase PH20: pharmacokinetics and tolerability in minipigs","author":"Nolan","year":"2026","journal-title":"Drug Deliv. Transl. Res."},{"key":"10.1016\/j.jconrel.2026.115308_bb0080","doi-asserted-by":"crossref","first-page":"1332","DOI":"10.3390\/jcm10061332","article-title":"Whole-body pharmacokinetics and physiologically based pharmacokinetic model for monomethyl auristatin E (MMAE)","volume":"10","author":"Chang","year":"2021","journal-title":"J. Clin. Med."},{"key":"10.1016\/j.jconrel.2026.115308_bb0085","doi-asserted-by":"crossref","first-page":"1148","DOI":"10.1002\/jcph.920","article-title":"Population pharmacokinetics of brentuximab vedotin in patients with CD30-expressing hematologic malignancies","volume":"57","author":"Li","year":"2017","journal-title":"J. Clin. Pharmacol."},{"key":"10.1016\/j.jconrel.2026.115308_bb0090","first-page":"R1003","article-title":"Determination of plasma volume in swine by the enzyme-dilution method","volume":"252","author":"Holmes","year":"1987","journal-title":"Am. J. Phys."},{"key":"10.1016\/j.jconrel.2026.115308_bb0095","doi-asserted-by":"crossref","first-page":"1637","DOI":"10.1111\/bcp.16057","article-title":"Development of a generalized pharmacokinetic model to characterize clinical pharmacokinetics of monomethyl auristatin E-based antibody-drug conjugates","volume":"90","author":"Chang","year":"2024","journal-title":"Br. J. Clin. Pharmacol."},{"key":"10.1016\/j.jconrel.2026.115308_bb0100","doi-asserted-by":"crossref","first-page":"1907","DOI":"10.1007\/s11095-014-1585-y","article-title":"Semi-mechanistic multiple-analyte pharmacokinetic model for an antibody-drug-conjugate in cynomolgus monkeys","volume":"32","author":"Lu","year":"2015","journal-title":"Pharm. Res."},{"key":"10.1016\/j.jconrel.2026.115308_bb0120","doi-asserted-by":"crossref","first-page":"3470","DOI":"10.1007\/s11095-014-1584-z","article-title":"Preclinical pharmacokinetic considerations for the development of antibody drug conjugates","volume":"32","author":"Kamath","year":"2015","journal-title":"Pharm. Res."},{"key":"10.1016\/j.jconrel.2026.115308_bb0125","doi-asserted-by":"crossref","first-page":"2551","DOI":"10.1007\/s11095-022-03294-y","article-title":"Mechanistic modeling of the effect of recombinant human hyaluronidase (rHuPH20) on subcutaneous delivery of cetuximab in rats","volume":"39","author":"Gao","year":"2022","journal-title":"Pharm. Res."},{"key":"10.1016\/j.jconrel.2026.115308_bb0130","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1208\/s12248-020-00446-z","article-title":"Subcutaneous site-of-absorption study with the monoclonal antibody tocilizumab in minipigs: administration behind ear translates best to humans","volume":"22","author":"Richter","year":"2020","journal-title":"AAPS J."},{"key":"10.1016\/j.jconrel.2026.115308_bb0135","doi-asserted-by":"crossref","first-page":"385","DOI":"10.1007\/s10928-020-09691-3","article-title":"Predicting monoclonal antibody pharmacokinetics following subcutaneous administration via whole-body physiologically-based modeling","volume":"47","author":"Hu","year":"2020","journal-title":"J. Pharmacokinet. Pharmacodyn."},{"key":"10.1016\/j.jconrel.2026.115308_bb0140","doi-asserted-by":"crossref","DOI":"10.1016\/j.mvr.2021.104228","article-title":"Transport and lymphatic uptake of monoclonal antibodies after subcutaneous injection","volume":"139","author":"Rahimi","year":"2022","journal-title":"Microvasc. Res."},{"key":"10.1016\/j.jconrel.2026.115308_bb0145","doi-asserted-by":"crossref","DOI":"10.1111\/cts.13788","article-title":"Modeling the subcutaneous pharmacokinetics of antibodies co-administered with rHuPH20","volume":"17","author":"Nolan","year":"2024","journal-title":"Clin. Transl. Sci."},{"issue":"1","key":"10.1016\/j.jconrel.2026.115308_bb0105","doi-asserted-by":"crossref","first-page":"5","DOI":"10.3390\/cancers18010005","article-title":"Pharmacokinetic and pharmacodynamic modeling of antibody-drug conjugates","volume":"18","author":"Glassman","year":"2026","journal-title":"Cancers"},{"key":"10.1016\/j.jconrel.2026.115308_bb0110","doi-asserted-by":"crossref","first-page":"2045","DOI":"10.1111\/bcp.13996","article-title":"Evaluation of covariate effects on pharmacokinetics of monoclonal antibodies in oncology","volume":"85","author":"Bajaj","year":"2019","journal-title":"Br. J. Clin. Pharmacol."},{"key":"10.1016\/j.jconrel.2026.115308_bb0115","doi-asserted-by":"crossref","DOI":"10.1016\/j.esmoop.2024.104002","article-title":"Sex differences in the pharmacokinetics of anticancer drugs: a systematic review","volume":"9","author":"Delahousse","year":"2024","journal-title":"ESMO Open"}],"container-title":["Journal of Controlled Release"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0168365926007121?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0168365926007121?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T05:18:56Z","timestamp":1793337536000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0168365926007121"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,11]]},"references-count":29,"alternative-id":["S0168365926007121"],"URL":"https:\/\/doi.org\/10.1016\/j.jconrel.2026.115308","relation":{},"ISSN":["0168-3659"],"issn-type":[{"value":"0168-3659","type":"print"}],"subject":[],"published":{"date-parts":[[2026,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Effect of berahyaluronidase alfa on subcutaneous absorption and local tolerability of ALT-P7, an antibody-drug conjugate in preclinical studies","name":"articletitle","label":"Article Title"},{"value":"Journal of Controlled Release","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jconrel.2026.115308","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"115308"}}