{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T06:49:42Z","timestamp":1791614982528,"version":"4.3.4"},"reference-count":28,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T00:00:00Z","timestamp":1780099200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Landsforeningen Fors\u00f8gsdyrenes V\u00e6rn"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Altern Lab Anim"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:p>\n                    The UK\u2019s 2025\n                    <jats:italic toggle=\"yes\">Replacing Animals in Science<\/jats:italic>\n                    strategy introduces a commitment to end polyclonal antibody reagent production by 2030. While this represents a significant milestone, focusing exclusively on polyclonal reagents raises scientific, ethical and implementation challenges, given that monoclonal and other recombinant antibody formats frequently remain dependent on animal immunisation. This study examines whether current UK licensing practice and reporting frameworks are positioned to deliver genuine\n                    <jats:italic toggle=\"yes\">replacement<\/jats:italic>\n                    . A structured, Three Rs-aligned\n                    <jats:italic toggle=\"yes\">replacement<\/jats:italic>\n                    framework is articulated, reflecting the principles set out in the UK Animals in Science Committee (ASC) 2022 review. This framework is applied to UK Non-Technical Summaries (NTS), to assess how antibody reagent production is justified at the project licence stage and the extent to which applications align with ASC expectations. In parallel, UK Home Office Annual Statistics of Scientific Procedures on Living Animals are analysed, to evaluate how antibody-related procedures are categorised, and to determine whether this national reporting enables progress toward the 2030 commitment to be monitored. The analysis identifies limited implementation of ASC\n                    <jats:italic toggle=\"yes\">replacement<\/jats:italic>\n                    guidance in post-2022 licences, with few applications providing evidence-based interrogation of non-animal alternatives, documented use of validated\n                    <jats:italic toggle=\"yes\">in vitro<\/jats:italic>\n                    discovery platforms, or robust justification for immunisation. The national statistics lack sufficient resolution to clearly capture immunisation-dependent antibody reagent production across commercial, basic and translational research contexts. In addition, inconsistent terminology complicates the interpretation of genuine\n                    <jats:italic toggle=\"yes\">replacement<\/jats:italic>\n                    . Importantly, the findings indicate that, without complementary regulatory, reporting and infrastructural measures, the 2030 commitment risks being met through increased reliance on other immunisation-dependent antibody formats, geographical outsourcing, or reduced visibility of antibody production that is embedded within broader research categories, rather than through genuine\n                    <jats:italic toggle=\"yes\">replacement<\/jats:italic>\n                    . Achieving the intended reduction in animal use will therefore require clearer terminology, improved reporting resolution, wider access to non-animal discovery infrastructure and the integration of a Three Rs-aligned decision framework into licensing expectations.\n                  <\/jats:p>","DOI":"10.1177\/02611929261455318","type":"journal-article","created":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T14:29:01Z","timestamp":1780151341000},"page":"206-216","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Replacing immunisation-dependent antibody reagent production: Challenges under the UK\n                    <i>Replacing<\/i>\n                    <i>Animals in<\/i>\n                    <i>Science<\/i>\n                    2025 strategy"],"prefix":"10.1177","volume":"54","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3060-461X","authenticated-orcid":false,"given":"Alison C.","family":"Gray","sequence":"first","affiliation":[{"name":"School of Veterinary Medicine and Science, The University of Nottingham, Sutton Bonington, Leicestershire, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5211-2088","authenticated-orcid":false,"given":"Kevin C.","family":"Gough","sequence":"additional","affiliation":[{"name":"School of Veterinary Medicine and Science, The University of Nottingham, Sutton Bonington, Leicestershire, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,5,30]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1038\/518027a"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1080\/19420862.2018.1445456"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1038\/521274a"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.tibtech.2016.05.017"},{"key":"e_1_3_4_6_2","first-page":"33","article-title":"Directive 2010\/63\/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes","author":"European Commission","year":"2010","unstructured":"European Commission. Directive 2010\/63\/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Off J Euro Union. 2010; L276, 20.10.2010: 33\u201379.","journal-title":"Off J Euro Union"},{"key":"e_1_3_4_7_2","volume-title":"EURL ECVAM recommendation on non-animal-derived antibodies","author":"Barroso J","year":"2020","unstructured":"Barroso J, Halder M, Whelan M. EURL ECVAM recommendation on non-animal-derived antibodies. Luxembourg: Publications Office of the European Union, 2020. https:\/\/doi.org\/10.2760\/091625"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41587-020-0687-9"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1177\/02611929251324520"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1177\/02611929241266472"},{"key":"e_1_3_4_11_2","unstructured":"ASC. Review of antibody licences: Report by the Animals in Science Committee. https:\/\/www.gov.uk\/government\/publications\/review-of-antibody-licences-report-by-the-animals-in-science-committee (2022 accessed 16 April 2026)."},{"key":"e_1_3_4_12_2","volume-title":"Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods","author":"Department for Science, Innovation and Technology, Home Office and Department for Environment, Food & Rural Affairs","year":"2025","unstructured":"Department for Science, Innovation and Technology, Home Office and Department for Environment, Food & Rural Affairs. Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods. https:\/\/www.gov.uk\/government\/publications\/replacing-animals-in-science-strategy\/replacing-animals-in-science-a-strategy-to-support-the-development-validation-and-uptake-of-alternative-methods (2025, accessed 16 April 2026)."},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1177\/02611929251371129"},{"key":"e_1_3_4_14_2","volume-title":"The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012","author":"UK Government","unstructured":"UK Government. The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012. https:\/\/www.legislation.gov.uk\/ukdsi\/2012\/9780111530313 (accessed 16 April 2026)."},{"key":"e_1_3_4_15_2","unstructured":"Home Office. Non-technical summaries of projects granted under ASPA Non-technical summaries by year. https:\/\/www.gov.uk\/government\/collections\/non-technical-summaries-of-projects-granted-under-aspa#non-technical-summaries-by-year (accessed 16 April 2026)."},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1177\/02611929251333981"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12033-021-00442-4"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.7554\/eLife.24903"},{"key":"e_1_3_4_19_2","first-page":"153","article-title":"DARPins: A true alternative to antibodies","volume":"10","author":"Stumpp MT","year":"2007","unstructured":"Stumpp MT, Amstutz P. DARPins: A true alternative to antibodies. Curr Opin Drug Discov Devel. 2007; 10: 153\u2013159.","journal-title":"Curr Opin Drug Discov Devel"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrmicro1458"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1039\/D5AN00663E"},{"key":"e_1_3_4_22_2","first-page":"101","article-title":"Construction of polyclonal antibody libraries using phage display","volume":"178","author":"Sharon J","year":"2002","unstructured":"Sharon J, Sompuram SR, Yang CY, et al. Construction of polyclonal antibody libraries using phage display. Methods Mol Biol. 2002; 178: 101\u2013112.","journal-title":"Methods Mol Biol"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.4161\/19420862.2015.989047"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-025-09721-5"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.3390\/antib9020012"},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2004.04.007"},{"key":"e_1_3_4_27_2","doi-asserted-by":"publisher","DOI":"10.1038\/nbt1126"},{"key":"e_1_3_4_28_2","unstructured":"Home Office. Guidance: Animal testing and research: Annual returns. [Published 1 December 2017 updated 21 December 2022]. https:\/\/www.gov.uk\/guidance\/animal-testing-and-research-annual-returns (2022 accessed 16 April 2026)."},{"key":"e_1_3_4_29_2","volume-title":"Accredited official statistics. Scientific procedures on living animals, Great Britain 2024","author":"Home Office","year":"2025","unstructured":"Home Office. Accredited official statistics. Scientific procedures on living animals, Great Britain 2024. https:\/\/www.gov.uk\/government\/statistics\/scientific-procedures-on-living-animals-great-britain-2024 (2025, accessed 16 April 2026)."}],"container-title":["Alternatives to Laboratory Animals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/02611929261455318","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/02611929261455318","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/02611929261455318","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T06:20:31Z","timestamp":1791613231000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/02611929261455318"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,30]]},"references-count":28,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1177\/02611929261455318"],"URL":"https:\/\/doi.org\/10.1177\/02611929261455318","relation":{},"ISSN":["0261-1929","2632-3559"],"issn-type":[{"value":"0261-1929","type":"print"},{"value":"2632-3559","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,30]]}}}