{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T07:52:22Z","timestamp":1777449142819,"version":"3.51.4"},"reference-count":75,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2002,1,1]],"date-time":"2002-01-01T00:00:00Z","timestamp":1009843200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Altern Lab Anim"],"published-print":{"date-parts":[[2002,1]]},"abstract":"<jats:p>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) \u2014 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.<\/jats:p>","DOI":"10.1177\/026119290203000109","type":"journal-article","created":{"date-parts":[[2019,4,10]],"date-time":"2019-04-10T00:28:46Z","timestamp":1554856126000},"page":"93-108","source":"Crossref","is-referenced-by-count":4,"title":["ECVAM's Contributions to the Implementation of the Three Rs in the Production and Quality Control of Biologicals"],"prefix":"10.1177","volume":"30","author":[{"given":"Marlies","family":"Halder","sequence":"first","affiliation":[{"name":"ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, 21020 Ispra (VA), Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Coenraad","family":"Hendriksen","sequence":"additional","affiliation":[{"name":"National Institute of Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands"},{"name":"Netherlands Centre Alternatives to Animal Use (NCA), Utrecht University, Yalelaan 17, 3584 CL Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus","family":"Cussler","sequence":"additional","affiliation":[{"name":"Paul Ehrlich Institute, Paul-Ehrlich-Strasse 51\u201359, 63225 Langen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Balls","sequence":"additional","affiliation":[{"name":"ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, 21020 Ispra (VA), Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2002,1,1]]},"reference":[{"key":"bibr1-026119290203000109","first-page":"211","volume":"23","author":"Curren R.D.","year":"1995","journal-title":"ATLA"},{"key":"bibr2-026119290203000109","first-page":"129","volume":"23","author":"Balls M.","year":"1995","journal-title":"ATLA"},{"key":"bibr3-026119290203000109","first-page":"7","volume":"22","author":"ECVAM","year":"1994","journal-title":"ATLA"},{"key":"bibr4-026119290203000109","first-page":"420","volume":"22","author":"Hendriksen C.F.M.","year":"1994","journal-title":"ATLA"},{"key":"bibr5-026119290203000109","first-page":"699","volume":"23","author":"Garthoff B.","year":"1995","journal-title":"ATLA"},{"key":"bibr6-026119290203000109","first-page":"925","volume":"24","author":"Schade R.","year":"1996","journal-title":"ATLA"},{"key":"bibr7-026119290203000109","first-page":"121","volume":"25","author":"Marx U.","year":"1997","journal-title":"ATLA"},{"key":"bibr8-026119290203000109","first-page":"747","volume":"26","author":"Hendriksen C.F.M.","year":"1998","journal-title":"ATLA"},{"key":"bibr9-026119290203000109","first-page":"79","volume":"27","author":"Leenaars P.P.A.M.","year":"1999","journal-title":"ATLA"},{"key":"bibr10-026119290203000109","first-page":"241","volume":"28","author":"Bruckner L.","year":"2000","journal-title":"ATLA"},{"key":"bibr11-026119290203000109","first-page":"99","volume":"29","author":"Hartung T.","year":"2001","journal-title":"ATLA"},{"key":"bibr12-026119290203000109","doi-asserted-by":"publisher","DOI":"10.1016\/S0264-410X(97)00074-1"},{"key":"bibr13-026119290203000109","first-page":"567","volume":"8","author":"Council of Europe","year":"1996","journal-title":"Pharmeuropa"},{"key":"bibr14-026119290203000109","first-page":"567","volume":"8","author":"Council of Europe","year":"1996","journal-title":"Pharmeuropa"},{"key":"bibr15-026119290203000109","first-page":"549","volume":"26","author":"Halder M.","year":"1998","journal-title":"ATLA"},{"key":"bibr16-026119290203000109","first-page":"523","volume":"26","author":"Hendriksen C.F.M.","year":"1998","journal-title":"ATLA"},{"key":"bibr17-026119290203000109","first-page":"383","volume":"26","author":"ECVAM","year":"1998","journal-title":"ATLA"},{"key":"bibr18-026119290203000109","unstructured":"BrownF., CusslerK. & HendriksenC. eds (1996). 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