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Towards in vitro potency testing of inactivated erysipelas vaccines
1Department Veterinary Medicines, Section Bacterial Vaccines and Immune Sera, Paul-Ehrlich-Institut, Langen Germany. balel@pei.de
Abstract:
Ph. Eur. Monograph 0064 "Swine erysipelas vaccine (inactivated)" currently advises mouse serology for batch potency testing. However, technological advances in vaccine production, improved quality control systems and comprehensive post marketing surveillance increasingly promote the acceptance of non-animal approaches for batch release testing. Protein and immune profiles of inactivated swine erysipelas vaccines obtained by SDS-PAGE and Western Blot might offer a convenient global and functional in vitro alternative. Characteristic and consistent protein and immune profiles could be obtained for aluminium-adjuvanted vaccines. Immunoreactivity of polyclonal sera raised in mice differs markedly from reactivity of swine sera.
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