Three Rs approaches in the production and quality control of fish vaccines
By Paul J. Midtlyng, Coenraad Hendriksen, Elisabeth Balks, Lukas Bruckner, Lawrence Elsken, Øystein Evensen, Kjetil Fyrand, Allison Guy, Marlies Halder, Penny Hawkins, Gunn Kisen, Anne Berit Romstad, Kira Salonius, Patrick Smith, Lynne U. Sneddon
|Category:||animal tests - animal welfare - antibodies - antigens - fish - industry - quality control - vaccines - animal use replacement - animal use reduction - animal use refinement - vaccine development|
The workshop on Three Rs Approaches in the Production and Quality Control of Fish Vaccines aimed a) to identify animal tests currently stipulated for the production and quality control of fish vaccines and to highlight animal welfare concerns associated with these tests; b) to identify viable options to replace, reduce, and refine animal use for fish vaccine testing; and c) to discuss the way forward and set out how the Three Rs may be implemented without jeopardizing the quality of the vaccines. The workshop participants – experts from academia, regulatory authorities, a scientific animal welfare organization, and the fish vaccine industry – agreed that efforts should be undertaken to replace the vaccination-challenge batch potency testing with tests based on antigen quantification or antibody response tests. Regulatory requirements of questionable scientific value and relevance for the quality of fish vaccines, such as the re-testing of batches produced outside Europe, or the double-dose batch safety test, should be re-considered. As an immediate measure the design of the current animal tests should be evaluated and modified in the light of refinement and reduction, for example, the number of unprotected control fish in vaccination-challenge tests should be reduced to the minimum.
Issued: March 2011
NALT Subject geographic: Europe
Journal Title: Biologicals
Volume issue: 39 v. 2 no.
Pages: 117 - 128
Publisher: Elsevier Ltd
AGRICOLA identifier: IND600902619
DOI identifier: 10.1016/j.biologicals.2011.02.001
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