{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T10:49:22Z","timestamp":1774435762278,"version":"3.50.1"},"reference-count":30,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2017,7,1]],"date-time":"2017-07-01T00:00:00Z","timestamp":1498867200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2017,6,1]],"date-time":"2017-06-01T00:00:00Z","timestamp":1496275200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"EPAA"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Biologicals"],"published-print":{"date-parts":[[2017,7]]},"DOI":"10.1016\/j.biologicals.2017.05.006","type":"journal-article","created":{"date-parts":[[2017,6,7]],"date-time":"2017-06-07T10:15:25Z","timestamp":1496830525000},"page":"55-65","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":26,"special_numbering":"C","title":["Modern science for better quality control of medicinal products \u201cTowards global harmonization of 3Rs in biologicals\u201d: The report of an EPAA workshop"],"prefix":"10.1016","volume":"48","author":[{"given":"Katrin","family":"Schutte","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Szczepanska","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marlies","family":"Halder","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus","family":"Cussler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ursula G.","family":"Sauer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catrina","family":"Stirling","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sylvie","family":"Uhlrich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iwona","family":"Wilk-Zasadna","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"John","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Bopst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joerg","family":"Garbe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harrie L.","family":"Glansbeek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robin","family":"Levis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pieter-Jan","family":"Serreyn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dean","family":"Smith","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Stickings","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.biologicals.2017.05.006_bib1","series-title":"The principles of humane experimental technique","author":"Russell","year":"1959"},{"key":"10.1016\/j.biologicals.2017.05.006_bib2","unstructured":"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. OJ L 276\/33, 20 Oct 2010."},{"key":"10.1016\/j.biologicals.2017.05.006_bib3","author":"WHO"},{"key":"10.1016\/j.biologicals.2017.05.006_bib4","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1016\/j.biologicals.2010.12.001","article-title":"The consistency approach for quality control of vaccines - a strategy to improve quality control and implement 3Rs","volume":"39","author":"De Mattia","year":"2011","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2017.05.006_bib5","first-page":"115","article-title":"Consistency as tool to support in\u00a0vitro batch potency testing in GMP production","volume":"134","author":"Stirling","year":"2012","journal-title":"Dev Biol (Basel)"},{"key":"10.1016\/j.biologicals.2017.05.006_bib6","doi-asserted-by":"crossref","first-page":"530","DOI":"10.1016\/j.immuni.2010.09.017","article-title":"Reverse vaccinology: developing vaccines in the era of genomics","volume":"33","author":"Sette","year":"2010","journal-title":"Immunity"},{"key":"10.1016\/j.biologicals.2017.05.006_bib7","series-title":"European pharmacopoeia","year":"2015"},{"issue":"127","key":"10.1016\/j.biologicals.2017.05.006_bib8","article-title":"Rules and Regulations. Implementation of Revocation of general safety test regulations that are duplicative of requirements in biologics license applications","volume":"80","author":"US FDA","year":"2015","journal-title":"Fed Regist"},{"key":"10.1016\/j.biologicals.2017.05.006_bib9","volume":"vol. 800","author":"WHO","year":"1990"},{"key":"10.1016\/j.biologicals.2017.05.006_bib10","series-title":"Abnormal toxicity \u2013 a study in the relevance of the requirement V 2.1.5 of the \u201cDeutsche Arzneibuch\u201d (German Pharmacopeia) for vaccines, immunosera and immunoglobulins","author":"Duchow","year":"1994"},{"key":"10.1016\/j.biologicals.2017.05.006_bib11","doi-asserted-by":"crossref","first-page":"1047","DOI":"10.1016\/S0264-410X(97)00074-1","article-title":"Elimination of abnormal toxicity test for sera and certain vaccines in the European Pharmacopoeia","volume":"15","author":"Schwanig","year":"1997","journal-title":"Vaccine"},{"key":"10.1016\/j.biologicals.2017.05.006_bib12","doi-asserted-by":"crossref","first-page":"509","DOI":"10.1016\/j.yrtph.2015.09.033","article-title":"Potential confounding effects of benzyl alcohol as a formulation excipient support the elimination of the abnormal toxicity test from pharmacopoeias","volume":"73","author":"Xie","year":"2015","journal-title":"Regul Toxicol Pharmacol"},{"key":"10.1016\/j.biologicals.2017.05.006_bib13","doi-asserted-by":"crossref","first-page":"3349","DOI":"10.1002\/jps.24125","article-title":"Historical data analyses and scientific knowledge suggest complete removal of the abnormal toxicity test as a quality control test","volume":"103","author":"Garbe","year":"2014","journal-title":"J\u00a0Pharm Sci"},{"key":"10.1016\/j.biologicals.2017.05.006_bib14","series-title":"Vaccines for veterinary use (Supplement 7.7). Harmonization with VICH Guidelines 41 and 44 and deletion of the TABST","author":"EDQM","year":"2012"},{"key":"10.1016\/j.biologicals.2017.05.006_bib15","unstructured":"EDQM website. https:\/\/www.edqm.eu\/en\/Achievements-of-the-PhEur-Commission-for-3Rs-1533.html (accessed 21 November 2016)."},{"key":"10.1016\/j.biologicals.2017.05.006_bib16","series-title":"Harmonization of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use","author":"VICH","year":"2013"},{"key":"10.1016\/j.biologicals.2017.05.006_bib17","series-title":"Veterinary services memorandum No. 800.116. Animal safety testing exemption","author":"USDA","year":"2013"},{"key":"10.1016\/j.biologicals.2017.05.006_bib18","doi-asserted-by":"crossref","first-page":"106","DOI":"10.1016\/j.provac.2011.10.007","article-title":"Alternative methods and strategies to reduce, refine, and replace animal use for veterinary vaccine post-licensing safety testing: state of the science and future directions","volume":"5","author":"Kulpa-Eddy","year":"2011","journal-title":"Vaccinol"},{"key":"10.1016\/j.biologicals.2017.05.006_bib19","author":"EU Commission"},{"key":"10.1016\/j.biologicals.2017.05.006_bib20","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1016\/j.provac.2011.10.002","article-title":"Non-animal replacement methods for human vaccine potency testing: state of the science and future directions","volume":"5","author":"McFarland","year":"2011","journal-title":"Procedia Vaccinol"},{"key":"10.1016\/j.biologicals.2017.05.006_bib21","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1016\/j.jim.2009.09.002","article-title":"Development and use of a novel in\u00a0vitro assay for testing of diphtheria toxoid in combination vaccines","volume":"350","author":"Coombes","year":"2009","journal-title":"J\u00a0Immunol Methods"},{"key":"10.1016\/j.biologicals.2017.05.006_bib22","doi-asserted-by":"crossref","first-page":"466","DOI":"10.1016\/j.biologicals.2012.07.011","article-title":"In\u00a0vitro antigen ELISA for quality control of tetanus vaccines","volume":"40","author":"Coombes","year":"2012","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2017.05.006_bib23","author":"WHO"},{"key":"10.1016\/j.biologicals.2017.05.006_bib24","doi-asserted-by":"crossref","first-page":"1477","DOI":"10.1016\/S0264-410X(00)00346-7","article-title":"Quality control of inactivated erysipelas vaccines: results of an international collaborative study to establish a new regulatory test","volume":"19","author":"Rosskopf-Streicher","year":"2000","journal-title":"Vaccine"},{"key":"10.1016\/j.biologicals.2017.05.006_bib25","series-title":"Inactivated swine erysipelas vaccine","author":"Ph. Eur. 4.6 Monograph 0064","year":"2004"},{"key":"10.1016\/j.biologicals.2017.05.006_bib26","article-title":"Center for Veterinary Biologics. Testing protocol SAM 613. Supplemental assay method for in\u00a0vitro potency testing of Erysipelothrix rhusiopathiae bacterins","author":"USDA","year":"2009","journal-title":"SAM"},{"key":"10.1016\/j.biologicals.2017.05.006_bib27","series-title":"Center for veterinary biologics notice No. 09-20","author":"USDA","year":"2009"},{"key":"10.1016\/j.biologicals.2017.05.006_bib28","author":"EURL ECVAM"},{"key":"10.1016\/j.biologicals.2017.05.006_bib29","author":"WHO"},{"key":"10.1016\/j.biologicals.2017.05.006_bib30","author":"ICH"}],"container-title":["Biologicals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1045105617300647?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1045105617300647?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2018,8,31]],"date-time":"2018-08-31T22:52:28Z","timestamp":1535755948000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1045105617300647"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,7]]},"references-count":30,"alternative-id":["S1045105617300647"],"URL":"https:\/\/doi.org\/10.1016\/j.biologicals.2017.05.006","relation":{},"ISSN":["1045-1056"],"issn-type":[{"value":"1045-1056","type":"print"}],"subject":[],"published":{"date-parts":[[2017,7]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Modern science for better quality control of medicinal products \u201cTowards global harmonization of 3Rs in biologicals\u201d: The report of an EPAA workshop","name":"articletitle","label":"Article Title"},{"value":"Biologicals","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.biologicals.2017.05.006","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2017 The Authors. Published by Elsevier Ltd on behalf of International Alliance for Biological Standardization.","name":"copyright","label":"Copyright"}]}}