{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,3,31]],"date-time":"2022-03-31T04:53:21Z","timestamp":1648702401109},"reference-count":26,"publisher":"Elsevier BV","issue":"5","content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Biologicals"],"published-print":{"date-parts":[[2013,9]]},"DOI":"10.1016\/j.biologicals.2013.06.012","type":"journal-article","created":{"date-parts":[[2013,7,16]],"date-time":"2013-07-16T08:45:38Z","timestamp":1373964338000},"page":"315-322","update-policy":"http:\/\/dx.doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":2,"title":["Development of Leptospira in\u00a0vitro potency assays: EU\/industry experience and perspectives"],"prefix":"10.1016","volume":"41","author":[{"given":"H.L.B.M.","family":"Klaasen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"van der Veen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.J.C.H.","family":"Molkenboer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"U.","family":"Bruderer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.biologicals.2013.06.012_bib1","doi-asserted-by":"crossref","first-page":"296","DOI":"10.1128\/CMR.14.2.296-326.2001","article-title":"Leptospirosis","volume":"14","author":"Levett","year":"2001","journal-title":"Clin Microbiol Rev"},{"key":"10.1016\/j.biologicals.2013.06.012_bib2","doi-asserted-by":"crossref","first-page":"6147","DOI":"10.1128\/IAI.70.11.6147-6157.2002","article-title":"Evaluation of type 1 immune response in na\u00efve and vaccinated animals following challenge with Leptospira borgpetersenii serovar Hardjo: involvement of WC1\u00a0+ \u03b3\u03b4 and CD4 T cells","volume":"70","author":"Naiman","year":"2002","journal-title":"Infect Immun"},{"key":"10.1016\/j.biologicals.2013.06.012_bib3","series-title":"Leptospira and leptospirosis","first-page":"108","author":"Faine","year":"1994"},{"key":"10.1016\/j.biologicals.2013.06.012_bib4","doi-asserted-by":"crossref","first-page":"287","DOI":"10.1016\/j.vetmic.2009.03.012","article-title":"Leptospira and leptospirosis","volume":"140","author":"Adler","year":"2010","journal-title":"Vet Microbiol"},{"key":"10.1016\/j.biologicals.2013.06.012_bib5","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1099\/00222615-23-1-1","article-title":"Opsonic monoclonal antibodies against lipopolysaccharide antigens of Leptospira interrogans serovar hardjo","volume":"23","author":"Farrelly","year":"1987","journal-title":"J\u00a0Med Microbiol"},{"key":"10.1016\/j.biologicals.2013.06.012_bib6","first-page":"277","article-title":"Leptospiral lipopolysaccharide presence in the outer envelope: electrophoretic evidence and immunological specificity","volume":"269","author":"Cinco","year":"1988","journal-title":"Zentralbl Bakteriol Mikrobiol Hyg A"},{"key":"10.1016\/j.biologicals.2013.06.012_bib7","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1111\/j.1574-695X.1994.tb00431.x","article-title":"Immunochemical studies of opsonic epitopes of the lipopolysaccharide of Leptospira interrogans serovar hardjo","volume":"8","author":"Vinh","year":"1994","journal-title":"FEMS Immunol Med Microbiol"},{"key":"10.1016\/j.biologicals.2013.06.012_bib8","doi-asserted-by":"crossref","first-page":"173","DOI":"10.1016\/S0378-1135(99)00103-0","article-title":"Development of an ELISA to detect antibodies to a protective lipopolysaccharide fraction of Leptospira borgpetersenii serovar hardjo in cattle","volume":"69","author":"Yan","year":"1999","journal-title":"Vet Microbiol"},{"key":"10.1016\/j.biologicals.2013.06.012_bib9","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1006\/biol.1999.0235","article-title":"The maintenance of challenge strains used in the potency test for canine Leptospira vaccines","volume":"28","author":"Reed","year":"2000","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2013.06.012_bib10","doi-asserted-by":"crossref","first-page":"337","DOI":"10.1016\/0092-1157(86)90021-1","article-title":"The development of a potency test for Leptospira hardjo vaccines: a comparison of protection in calves and serology in guinea pigs","volume":"14","author":"Goddard","year":"1986","journal-title":"J\u00a0Biol Stand"},{"key":"10.1016\/j.biologicals.2013.06.012_bib11","doi-asserted-by":"crossref","first-page":"100","DOI":"10.1016\/j.biologicals.2011.10.004","article-title":"Potency testing of veterinary vaccines: the way from in\u00a0vivo to in\u00a0vitro","volume":"40","author":"Romberg","year":"2012","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2013.06.012_bib12","doi-asserted-by":"crossref","first-page":"259","DOI":"10.1016\/S1045-1056(05)80045-4","article-title":"Assay for measuring relatively potency of leptospiral bacterins containing serovar Pomona","volume":"20","author":"Ruby","year":"1992","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2013.06.012_bib13","first-page":"99","article-title":"Alternatives to animal challenge tests in the batch control of Leptospira vaccines for veterinary use","year":"1999","journal-title":"Pharmeuropa Spec Issue Biol"},{"key":"10.1016\/j.biologicals.2013.06.012_bib14","unstructured":"European Directorate for the Quality of Medicines and HealthCare (EDQM). EDQM Workshop on Alternatives to the Leptospirosis Batch Potency Test. Available from: http:\/\/www.edqm.eu\/medias\/fichiers\/edqm_workshopleptospirosis_vaccine_batch_potency_t.pdf."},{"key":"10.1016\/j.biologicals.2013.06.012_bib15","first-page":"498","article-title":"The classification of Sejroe group serovars of Leptospira interrogans with monoclonal antibodies","volume":"259","author":"Terpstra","year":"1985","journal-title":"Zentralbl Bakteriol Mikrobiol Hyg A"},{"key":"10.1016\/j.biologicals.2013.06.012_bib16","first-page":"412","article-title":"Comparative classification of Leptospira serovars of the Pomona group by monoclonal antibodies and restriction-endonuclease analysis","volume":"266","author":"Terpstra","year":"1987","journal-title":"Zbl Bakt Hyg A"},{"key":"10.1016\/j.biologicals.2013.06.012_bib17","first-page":"15","article-title":"Classification of serovars of the Icterohaemorrhagiae serogroup by monoclonal antibodies","volume":"44","author":"Korver","year":"1988","journal-title":"Isr J Vet Med"},{"key":"10.1016\/j.biologicals.2013.06.012_bib18","first-page":"73","article-title":"An immunoprotective monoclonal antibody directed against Leptospira interrogans serovar copenhageni","volume":"135","author":"Schoone","year":"1989","journal-title":"J\u00a0Gen Microbiol"},{"key":"10.1016\/j.biologicals.2013.06.012_bib19","unstructured":"Royal Tropical Institute, KIT Biomedical Research. WHO\/FAO\/OIE and National Leptospirosis Reference Centre, Leptospira Library. Available from: www.kit.nl\/leptospira-library."},{"key":"10.1016\/j.biologicals.2013.06.012_bib20","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1016\/S0022-1759(02)00081-9","article-title":"Dialysis-based bioreactor systems for the production of monoclonal antibodies \u2013 alternatives to ascites production in mice","volume":"264","author":"Bruce","year":"2002","journal-title":"J\u00a0Immunol Methods"},{"key":"10.1016\/j.biologicals.2013.06.012_bib21","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1016\/0022-1759(87)90324-3","article-title":"A\u00a0simple, non-chromatographic procedure to purify immunoglobulins from serum and ascites fluid","volume":"96","author":"McKinney","year":"1987","journal-title":"J\u00a0Immunol Methods"},{"key":"10.1016\/j.biologicals.2013.06.012_bib22","doi-asserted-by":"crossref","first-page":"1084","DOI":"10.1177\/22.12.1084","article-title":"Peroxidase labeled antibody. A new method of conjugation","volume":"22","author":"Nakane","year":"1974","journal-title":"J\u00a0Histochem Cytochem"},{"key":"10.1016\/j.biologicals.2013.06.012_bib23","unstructured":"International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products (VICH). VICH guidelines. Available from: http:\/\/www.vichsec.org\/en\/guidelines2.htm."},{"key":"10.1016\/j.biologicals.2013.06.012_bib24","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1016\/0022-1759(85)90337-0","article-title":"Detection of monoclonal antibodies specific for carbohydrate epitopes using periodate oxidation","volume":"78","author":"Woodward","year":"1985","journal-title":"J\u00a0Immunol Methods"},{"key":"10.1016\/j.biologicals.2013.06.012_bib25","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1136\/vr.101100","article-title":"A\u00a0novel tetravalent Leptospira bacterin protects against infection and shedding following challenge in dogs","volume":"172","author":"Klaasen","year":"2013","journal-title":"Vet Rec"},{"key":"10.1016\/j.biologicals.2013.06.012_bib26","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 \u2013 a strategy to improve quality control and implement 3Rs","volume":"39","author":"de Mattia","year":"2011","journal-title":"Biologicals"}],"container-title":["Biologicals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1045105613000705?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1045105613000705?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2018,10,14]],"date-time":"2018-10-14T14:54:06Z","timestamp":1539528846000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1045105613000705"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,9]]},"references-count":26,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2013,9]]}},"alternative-id":["S1045105613000705"],"URL":"https:\/\/doi.org\/10.1016\/j.biologicals.2013.06.012","relation":{},"ISSN":["1045-1056"],"issn-type":[{"value":"1045-1056","type":"print"}],"subject":[],"published":{"date-parts":[[2013,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Development of Leptospira in\u00a0vitro potency assays: EU\/industry experience and perspectives","name":"articletitle","label":"Article Title"},{"value":"Biologicals","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.biologicals.2013.06.012","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.","name":"copyright","label":"Copyright"}]}}