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1. 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, and Werner E

Subjects
Animals, Cattle, Dogs, European Union, Pharmacopoeias as Topic, Bacterial Vaccines immunology, Bacterial Vaccines pharmacology, Bacterial Vaccines standards, Cattle Diseases immunology, Cattle Diseases prevention & control, Dog Diseases immunology, Dog Diseases prevention & control, Leptospira immunology, Leptospirosis immunology, Leptospirosis prevention & control, Leptospirosis veterinary, Vaccine Potency
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., (Copyright © 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.)

Published
2013
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