This paper summarises key activities initiated and the progress achieved between April 1993 and June 2002 in implementing 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 for the compilation of manuals and expert reports, and training in test methods. The paper complements the papers of Hendriksen et al. and Cussler et al. included in these proceedings.
HalderM., HendriksenC.F.M., CusslerK., & BallsM. (2002). ECVAM's contribution to the implementation of the Three Rs in the production and quality control of biologicals. ATLA30, 93–108.
2.
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.
3.
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.
4.
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.
5.
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.
6.
HendriksenC.F.M., 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.
7.
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.
8.
BrucknerL., BongersJ., CastleP., FloreP.H., GuittetM., HalderM., JungbäckC., Le GrosF.X., TollisM., VenugopalK., WilhelmM., ZeegersJ., & ZigtermanG. (2000). Three Rs approaches to the production and quality control of avian vaccines. The report and recommendations of ECVAM workshop 41. ATLA28, 241–258.
9.
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. Report and recommendations of ECVAM workshop 43. ATLA29, 99–123
10.
HalderM., EmbletonM.J., FischerR., de GeusB., HendriksenC.F.M., de LeeuwW.A., MarxU., & BallsM. (1998). Comments on Appendix C of the National Institutes of Health response to the petition of the American Anti-Vivisection society to prohibit the use of animals in the production of monoclonal antibodies. ATLA26, 549–554.
11.
HendriksenC.F.M. (1998). A call for a European prohibition on monoclonal antibody (mAb) production by the ascites procedure in laboratory animals. ATLA26, 523–540.
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ECVAM (1998). Statement on the scientific acceptability and practical availability of in vitro methods for the production of monoclonal antibodies. ATLA26, 383–386.
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HendriksenC., CusslerK., & HalderM. (2002). ECVAM's role in the implementation of the Three Rs concept in the field of biologicals. ATLA30, Suppl. 2, 41–46.
14.
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, 299–312.
15.
Rosskopf-StreicherU., JohannesS., WilhelmM., GyraH., & CusslerK. (1999). Potency testing of swine erysipelas vaccines by serology: results of a prevalidation study. ALTEX16, 123–128.
16.
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.
17.
ECVAM (2001). Statement on the application of the ELISA procedure for the batch potency testing of tetanus vaccines for human use. ATLA29, 93–94.
18.
ECVAM (2001). Statement on the application of the ToBI test for the batch potency testing of tetanus vaccines for human use. ATLA29, 94–96.
