Elisabeth Balks

Publications (2)3.4 Total impact

• Article: Potency testing of veterinary vaccines: the way from in vivo to in vitro.

  Judith Romberg, Stefan Lang, Elisabeth Balks, Elisabeth Kamphuis, Karin Duchow, Daniela Loos, Henriette Rau, Andreas Motitschke, Carmen Jungbäck
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  ABSTRACT: Current quality control of inactivated animal vaccines still focuses on the potency of final products in a batch-wise manner. Animal welfare concerns as well as scientific considerations have led to the '3Rs-concept' that comprises the refinement of animal procedures, the reduction of animal numbers, and the replacement of animal models. Although the 3Rs-concept has been widely accepted as a fundamental principle, the number of approved alternatives for in vivo tests is still limited. To promote further progress, the international scientific workshop 'Potency Testing of Veterinary Vaccines: The Way from in vivo to in vitro' was held at the Paul-Ehrlich-Institut in Langen, Germany, on 01-03 December 2010. More than 130 participants from industry, academia and regulatory authorities discussed the current state of the 3Rs-concept, examples of its successful implementation as well as still existing hurdles. Special emphasis was laid on the 'consistency approach' that aims to ensure relevant quality attributes of vaccine batches by in vitro analyses during production rather than by in vivo potency tests on the final product. This report provides an overview of the insights gained, including the recommendations produced at the end of the workshop.
  Biologicals 11/2011; 40(1):100-6. · 1.70 Impact Factor
• Article: Three Rs Approaches in the Production and Quality Control of Fish Vaccines.

  Paul J Midtlyng, Coenraad Hendriksen, Elisabeth Balks, Lukas Bruckner, Lawrence Elsken, Oystein Evensen, Kjetil Fyrand, Allison Guy, Marlies Halder, Penny Hawkins, Gunn Kisen, Anne Berit Romstad, Kira Salonius, Patrick Smith, Lynne U Sneddon
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  ABSTRACT: 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.
  Biologicals 03/2011; 39(2):117-28. · 1.70 Impact Factor