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  • Title: Development and validation of a serological potency test for the release of Leptospira vaccines--requirements in the European Union.
    Author: Balks E, Gyra H, Kobe B, Cussler K, Werner E.
    Journal: Biologicals; 2013 Sep; 41(5):325-9. PubMed ID: 23911253.
    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.
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