Izquierdo-López M, Cosme-Diaz K, García-Illera G, Núñez-Lamotte Z, Martínez-Cuéllar Y, Vega-Simón M, Costa-Anguiano L, Quintana-Esquivel M, Rosales-Torres I, Mosqueda-Lobaina O

Language: Spanish
References: 14
Page: 83-90
PDF size: 124.56 Kb.

ABSTRACT

In this paper the development of potency assay in animals (mice) was made, with the objective of demonstrating the immunogenic power of the recombinant Hepatitis B surface antigen in monovalent and combined vaccines, produced at the Center of Genetic Engineering and Biotechnology. The potency test is a parameter in quality control and it is also a tool to demonstrate the consistency of the production process. Parameters such as duration of the test, number of animals in the test, as well as different areas for the maintenance of the animals were evaluated. The results on the applicability of the potency test, to two presentations of the vaccines; monovalent Heberbiovac HB and pentavalent liquid in one vial Heberpenta-L are shown, for which specificity studies, evaluating different vaccine lots, the behavior of linearity, and parallelism, as well as establishing quality specification of the test were performed. This assay led to the obtainment of reliable results for the vaccines evaluated, the consistent evaluation of the immunogenic power and the monitoring of different production processes.

REFERENCES

1. World Health Organization. Requirements for Hepatitis B vaccines made by recombinant ADN techniques. Technical Report Series No 786. Geneva: WHO; 1989.

2. World Health Organization. Requirements for Hepatitis B vaccines made by recombinant ADN techniques. Technical Report Series No 889. Geneva: WHO; 1999.

3. European Pharmacopoeia. Assay of Hepatitis B Vaccine (rADN); General Chapter (2.7.15). In: European Pharmacopoeia Supplement 7.3 Edition. Strasbourg: European Pharmacopoeia; 2012.p.670-1.

4. World Health Organization. Guidelines non clinical evaluation of vaccines (Annex 1). Technical Report Series No. 927. Geneva: WHO; 2005.

5. Festing MFW. Guidelines for the Design and Statistical Analysis of Experiments to Papers Submitted to ATLA. ATLA 2001;29(4):427-46.

6. Ramírez V, González-Griego A, Alerm A, Izquierdo M, Peña M, Vega I, et al. Método inmunoenzimático para la cuantificación de anticuerpos anti-HBs. Biotecnología Aplicada 1993;10(2):102.

7. Finney DJ. Statistical Methods in Biological Assays. 2nd Ed. London: Charles Griffin & Company Lmtd; 1964.

8. Russell WMS, Burch RL. The principles of humane experimental technique. London: Methuen & Co. Ltd; 1959.

9. Izquierdo M, Ramírez V, Peña M, González-Griego A, Muzio V, Pentón E, et al. Inmunorespuesta para la vacuna recombinante contra la hepatitis B derivada de levadura. Biotecnología Aplicada 1993;10(2):103.

10. Ferguson M1, Heath A, Minor PD. Report of collaborative study for assessing the potency of hepatitis B vaccine. Biologicals 1990;18(4):345-50.

11. World Health Organization. Global Programmer for Vaccines and Immunization Vaccine Supply and quality. In: Manual of Laboratory Methods. Geneva: WHO; 1997.p.19-23.

12. European Pharmacopoeia. Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B (rADN) and Haemophylus type b conjugated vaccine (adsorbed), Poliomyelities inactived. In: European Pharmacopoeia 7.0. Edition 6th. Strasbourg: European Pharmacopoeia; 2008.p.758-67.

13. Expert Working Group ICH. Validation on Analytical Procedures: Text and Methodology Q2 (R1). In: Harmonised Tripartite Guideline. Geneva: ICH; 2005.p.1-13.

14. World Health Organization. Informal Consultation on Potency Testing of Hepatitis B Vaccines (Draft). Geneva: WHO August; 2008.