This paper summarises key activities initiated and the progress achieved between April 1993 and November 2002, in promoting the Three Rs in one of ECVAM's priority areas — the production and quality control of biologicals. These have included organising nine key workshops, financially supporting and/or participating in a number of prevalidation and/or validation studies, financial contributions and sponsorship to relevant international workshops, symposia and conferences, and financial support to the compilation of manuals, expert reports and training in test methods.
HalderM., HendriksenC., CusslerK., & BallsM. (2002). ECVAM's contributions to the implementation of the Three Rs in the production and quality control of biologicals. ATLA30, 93–108.
2.
WeisserK., & HechlerU. (1997). Animal welfare aspects in the quality control of immunobiologicals. A critical evaluation of animal tests in pharmacopoeial monographs, 348 pp. Nottingham, UK: FRAME for ECVAM and the Paul-Ehrlich-Institut.
3.
HendriksenC.F.M., GarthoffB., AggerbeckH., BrucknerL., CastleP., CusslerK., DobbelaerR., van de DonkH., van der GunJ.W., LefrancoisS., MilstienJ., MinorP.D., MougeotB., RombautB., RonnebergerH.D., SpieserJ-M., StolpR., StraughanD.W., TollisM., & ZigtermansC. (1994). Alternatives to animal testing in the quality control of immunobiologicals: current status and future prospects. The report and recommendations of ECVAM workshop 4. ATLA22, 420–434.
4.
GarthoffB., HendriksenC., BayolA., GoncalvesD., GrauerA., de LeeuwR., NoordwijkJ., ParesM., PirovanoR., RiethM., RonneberegerH., SpieserJ-M., StorringP., VosbeckK., & WeichertH. (1995). Safety and efficacy testing of hormones and related products. The report and recommendations of ECVAM workshop 9. ATLA23, 699–712.
5.
SchadeR., StaakC., HendriksenC., ErhardM., HuglH., KochG., LarrsonA., PollmannW., van RegenmortelM., RijkeE., SpielmannH., SteinbuschH., & StraughanD. (1996). The production of avian (egg yolk) antibodies: IgY. The report and recommendations of ECVAM workshop 21. ATLA24, 925–934.
6.
MarxU., EmbletonM.J., FischerR., GruberF.P., HanssonU., HeuerJ., de LeeuwW., LogtenbergT., MerzW., PortetelleD., RometteJ-L., & StraughanD. (1997). Monoclonal antibody production. The report and recommendations of ECVAM workshop 25. ATLA25, 121–137.
7.
HendriksenC., SpieserJ-M., AkkermansA., BallsM., BrucknerL., CusslerK., DaasA., DescampsJ., DobbelaerR., FentemJ., HalderM., van der KampM., LuckenR., MilstienJ., SesardicD., StraughanD., & ValadaresA. (1998). Validation of alternative methods for the potency testing of vaccines. The report and recommendations of ECVAM workshop 31. ATLA26, 747–761.
8.
LeenaarsP.P.A.M., HendriksenC.F.M., de LeeuwW.A., CaratF., DelahautP., FischerR., HalderM., HanlyW.C., HartingerJ., HauJ., LindbladE.B., NicklasW., OutschoornI.M., & Stewart-TullD.E.S. (1999). The production of polyclonal antibodies in laboratory animals. The report and recommendations of ECVAM workshop 35. ATLA27, 79–102.
9.
BrucknerL., BongersJ., CastleP., FloreP.H., GuittetM., HalderM., JungbäckC., Le GrosF.X., TollisM., VenugopalK., WilhelmM., ZeegersJ., & ZigtermanG. (2000). Three Rs approaches in the production and quality control of avian vaccines. The report and recommendations of ECVAM workshop 41. ATLA28, 241–258.
10.
HartungT., AabergeI., BertholdS., CarlinG., ChartonE., CoeckeS., FennrichS., FischerM., GommerM., HalderM., HaslovK., JahnkeM., Montag-LessingT., PooleS., SchechtmanL., WendelA., & Werner-FelmayerG. (2001). Novel pyrogen tests based on the human fever reaction. The report and recommendations of ECVAM workshop 43. ATLA29, 99–123.
11.
BrucknerL., CusslerK., & HalderM. (2002). Results and recommendation of an ECVAM workshop on alternatives in rabies vaccines quality control. In Program and Abstracts, Fourth World Congress on Alternatives and Animal Use in the Life Sciences, New Orleans, LA, USA, p. 74. Alternatives Congress Trust. Website http://www.worldcongress.net/abstract-book/contents.htm (Accessed 4.12.03).
12.
SchwanigM., NagelM., DuchowK., & KrämerB. (1997). Elimination of abnormal toxicity test for sera and certain vaccines in the European Pharmacopoeia. Vaccine15, 1047–1048.
13.
ChartonE. (1999). Reduction and replacement of animal tests in the European Pharmacopoeia: recent developments for monographs on biological substances. Pharmeuropa11, 197–199.
14.
HendriksenC.F.M. (1998). A call for a European prohibition on monoclonal antibody production by the ascites procedure in laboratory animals. ATLA26, 523–540.
HendriksenC.F.M., WoltjesJ., AkkermansA., van der GunJ.W., MarsmanF.R., VerschureM.H., & VeldmanK. (1994). Interlaboratory validation of in vitro serological assay systems to assess the potency of tetanus toxoid in vaccines for veterinary use. Biologicals22, 257–268.
17.
LensingH.H., Esposito-FareseM-E., DaasA., & SpieserJ-M. (2001). Collaborative study for the establishment of two European Pharmacopoeia Biological Reference Preparations for Clostridium tetani antiserum for the serological potency testing of tetanus vaccines for veterinary use. Pharmeuropa Special Issue BIO 2000-2, 43–54.
18.
EbertE., ÖpplingV., WernerE., & CusslerK. (1999). Development and prevalidation of two different ELISA systems for the potency testing of Clostridium perfringens beta and epsilon-toxoid containing veterinary vaccines. FEMS Immunology and Medical Microbiology24, 299–311.
19.
Rosskopf-StreicherU., JohannesS., WilhelmM., & CusslerK. (2000). Quality control of inactivated erysipelas vaccines: results of an international collaborative study to establish a new regulatory test. Vaccine19, 1477–1483.
20.
ECVAM (2001). Statement on the application of the ELISA procedure for the batch potency testing of tetanus vaccines for human use. ATLA29, 93–94.
21.
ECVAM (2001). Statement on the application of the ToBI test for the batch potency testing of tetanus vaccines for human use. ATLA29, 94–96.
22.
Council of Europe (2002). Assay of tetanus vaccine (absorbed). Pharmeuropa14, 549–554.
23.
Council of Europe (2002). Bovine leptospirosis vaccine (absorbed). Pharmeuropa14, 666–667.
HendriksenC.F.M., SteenB., VisserJ., CusslerK., MortonD.B., & StreijgerF. (1999). The evaluation of humane endpoints in pertussis vaccine potency testing. In Humane Endpoints in Animal Experiments for Biomedical Research. Proceedings of the International Conference, 22—25 November 1998, Zeist, The Netherlands (ed. HendriksenC., & MortonD.). London, UK: The Royal Society of Medicine Press Ltd.
26.
The HELP Group (2001). Humane endpoints — lethal parameters: humane endpoints replace lethal parameters in batch potency tests of rabies vaccines. The HELP Group, Bilthoven, The Netherlands. ATLA29, 503.
27.
StorringP.L., Gaines DasR.E., MuldersJ.W.M., & HalderM. (2002). Physiochemical methods for predicting the biological potency of recombinant follicle stimulating hormone: an international collaborative study of isoelectric focusing and capillary zone electrophoresis. Biologicals30, 217–234.
28.
WorthA., & BallsM. (2001). The role of ECVAM in promoting the regulatory acceptance of alternative methods in the European Union. ATLA29, 525–535.
29.
Council of Europe (2002). Swine erysipelas vaccine (inactivated). Pharmeuropa14, 69.
