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Development and validation of a serological potency test for the release of Leptospira vaccines--requirements in the European Union.
Balks, Elisabeth; Gyra, Heike; Kobe, Babett; Cussler, Klaus; Werner, Esther.
Affiliation
  • Balks E; 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.
Biologicals ; 41(5): 325-9, 2013 Sep.
Article in En | MEDLINE | ID: mdl-23911253
ABSTRACT
Both European Pharmacopoeia Monograph 01/20080447 "Canine Leptospirosis vaccine (inactivated)" and the more recent Monograph 01/20081939 "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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Bacterial Vaccines / Cattle Diseases / Dog Diseases / Vaccine Potency / Leptospira / Leptospirosis Limits: Animals Language: En Journal: Biologicals Journal subject: ALERGIA E IMUNOLOGIA Year: 2013 Document type: Article Publication country: ENGLAND / ESCOCIA / GB / GREAT BRITAIN / INGLATERRA / REINO UNIDO / SCOTLAND / UK / UNITED KINGDOM
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Bacterial Vaccines / Cattle Diseases / Dog Diseases / Vaccine Potency / Leptospira / Leptospirosis Limits: Animals Language: En Journal: Biologicals Journal subject: ALERGIA E IMUNOLOGIA Year: 2013 Document type: Article Publication country: ENGLAND / ESCOCIA / GB / GREAT BRITAIN / INGLATERRA / REINO UNIDO / SCOTLAND / UK / UNITED KINGDOM