Development and validation of a serological potency test for the release of Leptospira vaccines – Requirements in the European Union

• Ph. Eur. Monographs 0447 and 1939 allow for a serology test to assess batch potency.
• Test setup and requirements for in vivo and in vitro validation are described.
• Two strategies to assess batch potency and their specific demands are addressed.

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.