Potency testing of veterinary vaccines for animals

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The International Scientific Workshop on Potency Testing of Veterinary Vaccines for Animals took place in Langen, Germany, in December 2010. Before market release, inactivated vaccines are primarily tested in vivo using laboratory animals. Recent efforts have focused on modifying these tests to reduce animal use and stress (Refinement) or replacing them with in vitro methods. Acceptance of these alternatives varies among vaccine manufacturers and regulatory authorities, leading to hesitance in adopting new testing methods. The workshop aimed to advance this field, attracting over 130 participants from industry, academia, and regulatory bodies across 22 countries. Discussions included the current state of replacing in vivo tests, highlighting successful implementations and ongoing challenges. The advantages and disadvantages of existing replacement strategies were examined, and proposals for ensuring the quality of veterinary immunology medicinal products (IVMPs) were presented. The workshop identified hurdles to implementing the 3Rs in potency testing for inactivated veterinary vaccines and proposed a roadmap for future steps toward in vitro testing.