title: Workshop on Animal free Detection of Pertussis Toxin in Vaccines--Alternatives to the Histamine Sensitisation Test.
abstract: The Paul-Ehrlich-Institut (PEI), the Nederlands Vaccin Instituut (NVI) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised the international scientific workshop "Animal free Detection of Pertussis Toxin in Vaccines--Alternatives to the Histamine Sensitisation Test" at the PEI in Langen (Germany) on 09-10 June 2011. Twenty-seven experts (regulators, representatives from national control laboratories, vaccine manufacturers and academia) from 7 countries participated in this workshop. The meeting was triggered by the lack of satisfaction with the current safety testing for acellular pertussis vaccines, the "Histamine Sensitisation Test" (HIST) in mice, and the growing attention for the alternatives under development. The workshop objectives were: a) to review the current status of available alternative methods, b) to discuss the sensitivity that an alternative test needs, c) to plan experiments that allow for comparison of the alternative tests. The results of the workshop are summarised in this meeting report.
authors.affiliation: Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, D-63225 Langen, Germany. Christina.Bache@pei.de
authors.forename: Christina
authors.initials: C
authors.lastname: Bache
authors.forename: Marieke
authors.initials: M
authors.lastname: Hoonakker
authors.forename: Coenraad
authors.initials: C
authors.lastname: Hendriksen
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Buchheit
authors.forename: Ingo
authors.initials: I
authors.lastname: Spreitzer
authors.forename: Thomas
authors.initials: T
authors.lastname: Montag
mesh_terms: D006632:Histamine / Q000494:pharmacology*; D037342:Pertussis Toxin / Q000032:analysis*; D014612:Vaccines / Q000737:chemistry*
chemical_list: D014612:Vaccines; D006632:Histamine; D037342:Pertussis Toxin