Veteriner aşı ve biyolojik maddelerin kalite kontrollerinde alternatif metotlar

Son yıllarda veteriner aşı ve biyolojik maddelerin kalite kontrollerinde deneme hayvanı sayısının azaltılmasına yönelik geliştirilen alternatif yöntemlerin etkin olarak geliştirilmesi sonucunda, daha az sayıda deneme hayvanı kullanılarak daha etkin sonuçlara ulaşılmıştır. Bu sonuçların doğrultusunda hem üretilen aşı ve biyolojik maddelerin kalitesi daha iyi sorgulanmış hem de etik anlamda kullanılan deneme hayvanı sayısında önemli miktarlarda azalma sağlanmıştır.

Alternative methods in quality control of veterinary vaccine and biological materials

Recent years, as a result of the alternative methods developed in quality control of veterinary vaccines and biological products, using less experimental animals, more effective outcomes has been provided. From these results, the quality of the vaccines and biological products were investigated better, and the number of experimental animals used ethically.

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1. de Mattia F, Chapsal JM, Descamps J et al. The Consistency approach for quality control of vaccines - A strategy to improve quality control and implement 3Rs. Biologicals 2011; (39): 59-65.
2. Weisser K, Hechler U. Animal welfare aspects. In: the quality control of immunobiologicals. A critical evaluation of animal tests in pharmacopoeial monographs. Published by FRAME, Nottingham, UK for ECVAM and the Paul-Ehrlich-Institute. 1997.
3. EU. The rules governing medicinal products in the European Union. Eudralex: 1999; http://dg3.eudra. org/eudralex/download.htm
4. Wagner U, Hâdge D, Lachmann I, Drossier K. Development of an ELISA-system for the assessment of furunculosis vaccine (German). ALTEX 15 Supplement, 1998; 79-82.
5. Pund RP, Nold K. Henrion E. [Testing fish vaccines with an in vitro lymphocyte blastogenesis assay (German)]. ALTEX 15 Supplement, 1998; 75-79.
6. Council of Europe, Tetanus vaccine for veterinary use. Pharmeuropa 8, 1996; 238-240.
7. Hendriksen CFM, Woltjes J, Akkermans AM, van der Gun JW, Marsman FR, Verschure MH & Veldman K. Interlaboratory validation of in vitro serological' assay systems to assess the potency of tetanus toxoid in vaccines for veterinary use. Biologicals 1994; 22: 257-268.
8. Council of Europe, Alternative potency testing and other possible related quality issue for clostridial vaccines. Proceedings of the symposium on veterinary clostridial vaccines. 4-6 February 1997, Strasbourg, France. Pharmeuropa Special Issue, 1997; BIO 97-1, pp. 88. Strasbourg: Council of Europe
9. Borrmann E, Schulze F, Diller R. Entwicklung von in vitro Methoden zur VVirksamkeitsprüfung von Clostridien-Impfstoffen. ALTEX 2001; 18: 34-36.
10. Hauer PJ, Clough NE. Development of monoclonal antibodies suitable for use in antigen quantification potency tests for clostridial veterinary vaccines. In: Brown F, Hendriksen CFM, Sesardic D. (Editors), Alternatives to animals in the development and control ot biological products for human and veterinary use (85-94). Developments in Biological Standardization, Basel: S. Karger AG, 1999; 101.
11. Hauer PJ. Viewpoint from the USA authorities. Recent development on different clostridiae. Pharmeuropa Special Issue, 1997; BIO 97-1, 47-58.
12. Kijima-Tanaka, M, Ogikubo Y, Kojima S. Flagella based enzymelinked immunosorbent assay for evaluation the immunity in mice vaccinated with blackleg vaccines. Journal of Microbiological Methods 1998; 32: 79-85.
13. Redhead K, Lucken R, van de Moer A. Veterinary Vaccines: In-VITRO - International Veterinary Industry Test Replacement Organisation. In: Brown F, Hendriksen CFM, Sesardic D. (Editors), Alternatives to animals in the development and control of biological products for human and veterinary use (261-266). Developments in Biological Standardization, Basel: S. Karger AG, 1999; 101.
14. Rosskopf-Streicher U, Johannes S, Hausleithner D. Suitability of an ELISA for the batch potency testing of erysipelas vaccines. Pharmeuropa Special Issue, 1998; BIO 98-1, 65-70.
15. Roth F, Seifert, HSH. Development of in vitro methods for the potency testing of blackleg vaccines based on soluble and cellular antigens of C. chauvoie. Pharmeuropa Special Issue, 1997; BIO 97-1, 21-29.
16. Beckmann R, Cussler K. VVirksamkeitsprüfung von Rotlauf-impfstoffen an der Labormaus. ELISA kontra Infektionsversuch. ALTEX Supplement 1994; 1, 39-45.
17. Redhead K. Preparation of an inhouse reference vaccine: results of in vitro studies in pigs. Pharmeuropa Special Issue, 1998; BIO 98-1, 50-55.
18. Rosskopf-Streicher U, Johannes S, Wilhelm M, Cussler K. Quality control of inactivated erysipelas vaccines: results of an international collaborative study to establish a new regulatory test. Vaccine 2001; 19: 1477-1483.
19. Rosskopf-Streicher U, Johannes S, Wilhelm M. Potency testing of swine erysipeals vaccines by serology - reiults of a prevalidation study. ALTEX1999; 16: 123-128.
20. Marbehant P. Leptospiral vaccines batch potency testing. European monograph status review. Pharmeuropa Special Issue, 1999; BIO 99-2, 11-16.
21. Council of Europe, Alternatives to animal challenge tests in the batch control of Leptospira vaccines for veterinary use. Pharmeuropa Special Issue, 1999; BIO 99-2, pp. 135. Strasbourg: Council of Europe
22. Bruckner L, Bongers J, Castle P, ve ark. Three Rs approaches to the production and quality control of avian vaccines. The Report and Recommendations of ECVAM Workshop 41. ATLA 2000; 28, 241-258.
23. Maas RA, Oei HL, Kemper S. The use of homologous virus in the haemagglutination-inhibition assay after vaccination with Newcastle disease virus strain La Sota or clone 30 leads to an overestimation of protective serum antibody titers. Avian Pathology 1998; 27, 625-631.
24. Maas R, de Winter M, Koch G. Development of an in vitro potency test for inactivated newcastle disease vaccines. In Balls M, van Zeller AM, Haider ME. (Editors), Progress in the Reduction, Refinement and Replacement of Animal Experimentation Amsterdam: Elsevier Science B.V. 2000; 959-967.
25. Anderson EC, Capsick PB, Mowat GN, Leech FB. In vitro method for the safety testing of foot-and-mouth disease vaccines. J Hyg Camb 1970; 68: 159-17.
26. Black L, Rweyemamu MM, Boge A. Revaccination response of cattle as a function of the 140S foot-and-mouth disease antigen. Journal of Comparative Pathology 1984;94:417-424.
27. Pay TWF, Hingley PJ. Correlation of 140S antigen dose with the serum neutralising antibody response and the level of protection induced in cattle by foot-and-mouth disease vaccines. Vaccine 1987; 5: 60-64.
28. Rweyemamu MM, Black L, Boge A. The relationship between the 140S antigen dose in aqueous foot-and-mouth diesease vaccines and the serum antibody response of cattle. Journal of Biological Standardization 1984; 12, 111-120.
29. Hamblin C, Barnett ITR, Crowther JR. A new enzyme-linked immunosorbent assay (ELISA for the detection of antibodies against foot-and-mouth disease virus). Journal of Immunological Methods 1986; 93: 123-129.
30. Thalmann G, Nöckler A, Felfe P, Kreienbrink G. Erarbeitung und Einsatz von Laborverfahren zur VVirksamkeitsprüfung von Maul-und-Klauenseuche-Vakzinen für Rind und Schwein. Archives of Experimental Veterinary Medicine 1987; 41: 806-811.
31. Hendriksen CFM. Opportunities for replacement, reduction or refinement: Veterinary vaccines for mammals. In: Hendriksen CFM. (Editor), Laboratory Animals in Vaccine Production and Control, Dordrecht: Kluwer Academic Publishers, 1988; 125-139.
32. Blum SAE, Braunschweiger M, Kramer B. ve ark. Proof of complete virus inactivation in rabies vaccines by either intracerebral injection of mice or fluorescent antibody technique (FAT) - a quantitative comparison. In: Brown F, Hendriksen CFM, Sesardic D. (Editors), Alternatives to animals in the development and control of biological products for human and veterinary use (302). Developments in Biological Standardization, Basel: S. Karger AG, 1999; 101.
33. Ullrich L. Ersatzmethoden in der Diagnostik. In Tierlaboratorium Tieriaboratorien Zentrale, Institut für Tierschutz, Verhaltenslehre und Versuchstierkunde der Freien Universitât Berlin. Berlin: Universitâtsdruckerei 1993;107-119.
34. Zhengming HE. Altemetive methods for animal tests in the quality control of biologicals products of China. AATEXS 2007, 14, Special Issue, 591-593.
35. Brown F, Hendriksen C, Sesardic D, Cussler K, editors. Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones. Dev Biologicals, Basel: S. Karger AG, 2002; vol. 111.
36. Hendriksen CFM. Replacement, reduction and refinement alternatives to animal use in vaccine potency measurement. Expert Rev Vaccines 2009; 8: 313-322.
37. Metz B, Jiskoot W, Hennink WE, Crommelin DJ, Kersten GFM. Physicochemical and immunochemical techniques predict the quality of diphtheria toxoid vaccines. Vaccine 2003; 12: 156-167.