title: Development and validation of a serological potency test for the release of Leptospira vaccines--requirements in the European Union.
abstract: Both European Pharmacopoeia Monograph 01/2008:0447 "Canine Leptospirosis vaccine (inactivated)" and the more recent Monograph 01/2008:1939 "Bovine Leptospirosis vaccine (inactivated)" explicitly allow for a sero-response test to assess batch potency. Test setup and requirements for in vivo and in vitro validation are described. Furthermore, the two main strategies to assess batch potency and their specific demands are addressed.
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Veterinary Department, Section Bacterial Vaccines and Immune Sera, Paul-Ehrlich-Institut-Strasse 51-59, 63225 Langen, Germany. Electronic address: Elisabeth.Balks@pei.de.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Balks
authors.forename: Heike
authors.initials: H
authors.lastname: Gyra
authors.forename: Babett
authors.initials: B
authors.lastname: Kobe
authors.forename: Klaus
authors.initials: K
authors.lastname: Cussler
authors.forename: Esther
authors.initials: E
authors.lastname: Werner
mesh_terms: D000818:Animals; D001428:Bacterial Vaccines / Q000276:immunology / Q000494:pharmacology / Q000592:standards; D002417:Cattle; D002418:Cattle Diseases / Q000276:immunology / Q000517:prevention & control; D004283:Dog Diseases / Q000276:immunology / Q000517:prevention & control; D004285:Dogs; D005062:European Union; D007919:Leptospira / Q000276:immunology*; D007922:Leptospirosis / Q000276:immunology / Q000517:prevention & control / Q000662:veterinary; D010602:Pharmacopoeias as Topic; D064166:Vaccine Potency
chemical_list: D001428:Bacterial Vaccines
keywords: 3R; Alternative method; Batch potency; Leptospira; Serology; Vaccine