The Potential of Physicochemical and Immunochemical Assays to Replace Animal Tests in the Quality Control of Toxoid Vaccines - The Report and Recommendations of ECVAM Workshop 61a

Abstract

The workshop on the potential of physicochemical and immunochemical assays to replace animal tests in the quality control of toxoid vaccines was held at ECVAM on 14-15 April 2005, under the co-chairmanship of Coenraad Hendriksen and Gideon Kersten. The objectives of the workshop were: a) to review the state-of-the-art of physico-chemical, biochemical and immunochemical tests for the quality control of diphtheria and tetanus toxoid vaccines and b) to identify possibilities and limitations for their use in the regulatory framework, i.e. replacing the use of in vivo tests. The outcome of the discussions and the recommendations given by the workshop participants are summarised in this report.