Product-specific validation of a serological potency test for release of Leptospira vaccines in the European Union

Historically in the European Union, all Leptospira vaccines were released using the European Pharmacopoeia (Ph. Eur.) hamster potency assay. Recently, there has been a shift toward alternatives that offer either refinement of testing or replacement of animals for product release. This is being drive...

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Bibliographic Details
Published in:Biologicals 2013-09, Vol.41 (5), p.330-331
Main Authors: Stirling, Catrina, Novokova, Viera
Format: Article
Language:English
Subjects:
animal welfare
Animals
Bacterial Vaccines - immunology
Bacterial Vaccines - pharmacology
Bacterial Vaccines - standards
Cricetinae
Dog Diseases - immunology
Dog Diseases - prevention & control
Dogs
European Union
hamsters
Leptospira
Leptospira - immunology
Leptospirosis - immunology
Leptospirosis - prevention & control
Leptospirosis - veterinary
Potency
Rabbits
Serology
serotypes
Test
Vaccine
Vaccine Potency
vaccines
Validation
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Summary:Historically in the European Union, all Leptospira vaccines were released using the European Pharmacopoeia (Ph. Eur.) hamster potency assay. Recently, there has been a shift toward alternatives that offer either refinement of testing or replacement of animals for product release. This is being driven by animal welfare concerns but also by a drive to have more consistent, cheaper, and faster batch release tests. This publication discusses one such example of a multicomponent canine vaccine that includes three Leptospira serovars and has recently been registered in the European Union. The potency release test is a refinement because it uses rabbit serology rather than hamster challenge. This publication covers the principles of the test method, challenges faced during its development and registration, and discussion about benefits and limitations of this method. It concludes with a view of how the use of serology testing could fit into an overall strategy to move to fully in vitro testing by adopting a consistency approach. •Historically, all Leptospira vaccines in EU were released using a hamster assay.•There has been a recent shift toward 3Rs alternatives for product release.•This paper discusses a multicomponent canine vaccine recently registered in the EU.•The principles of the method and challenges faced during registration are covered.
ISSN:1045-1056
1095-8320
DOI:10.1016/j.biologicals.2013.06.004