Community Research and Development Information Service - CORDIS

Abstract

A summary is presented of the activities initiated, and the progress achieved, between April 1993 and December 2001 in implementing the Three Rs in one of the main priority areas of the European Centre for the Validation of Alternative Methods (ECVAM) - the production and quality control of biologicals. These have included organising eight key workshops, and financial contributions to, and sponsorship of, relevant international workshops, symposia and conferences. Noteworthy activities include financial support and/or participation in a number of prevalidation and validation studies. These involved alternative methods for the batch potency testing of: human tetanus vaccines, human and veterinary tetanus antisera and immunoglobulin, rabies vaccines, Leptospira hardjo vaccines, Clostridium perfringens vaccines, and erysipelas vaccines. They also involved a cell culture test for specific toxicity testing of diphtheria toxoid vaccines. In addition, ECVAM funded a study on the use of humane endpoints for vaccine quality control tests involving severe suffering, such as the potency testing of erysipelas, rabies and pertussis vaccines. ECVAM has also contributed financially to the compilation of manuals and expert reports, and to training in test methods. Following the report of an ECVAM Task Force, ECVAM financially supported the prevalidation of some in vitro methods for the potency testing of a recombinant hormone. A proposal is presented for promotion of regulatory acceptance, and suggestions are made for possible future activities.

Additional information

Authors: HALDER M, European Commission, Joint Research Centre, Institute for Health and Consumer Protection, European Centre for the Validation of Alternative Methods (ECVAM), Ispra (IT);BALLS M, European Commission, Joint Research Centre, Institute for Health and Consumer Protection, European Centre for the Validation of Alternative Methods (ECVAM), Ispra (IT);HENDRIKSEN C, National Institute of Public Health and the Environment (RIVM), Bilthoven (NL) and University of Utrecht (NL);CUSSLER K, Paul Ehrlich Institute, Langen (DE)
Bibliographic Reference: An article published in: ATLA 30, 93-108, January/February 2002
Availability: The full text of this article is available online at: http://altweb.jhsph.edu/publications/journals/atla/atla30_1/atla30_1i.htm
Record Number: 200214827 / Last updated on: 2002-06-19
Category: PUBLICATION
Original language: en
Available languages: en