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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 61

Bernard Metz, Florence Brunel, Catherine Chamberlin, Johan van der Gun, Marlies Halder, Wim Jiskoot, Gideon Kersten, Omer van Opstal, Jesper W. Petersen, Satish D. Ravetkar, Keith Redhead, Michael Schwanig, Ellen Sloth Wilhelmsen, Willie F. Vann and Coenraad Hendriksen

This is the 61st report of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). 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 cochairmanship of Coenraad Hendriksen and Gideon Kersten. The objectives of the workshop were: a) to review the state-of-the-art of physicochemical, biochemical and immunochemical tests for the quality control of diphtheria and tetanus toxoid vaccines; and b) to identify possibilities for and limitations to their use in the regulatory framework, i.e. for replacing the use of in vivo tests. The outcome of the discussions and the recommendations of the workshop participants are summarised in this report.