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2013, Number 2

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VacciMonitor 2013; 22 (2)

Improvements in the potency assay of Bordetella pertussis

del Puerto CA, Mandiarote A, Valle O, Núñez JF, Izquierdo L, Baños N, Labrador I
Full text How to cite this article

Language: Spanish
References: 11
Page: 40-42
PDF size: 76.62 Kb.


Key words:

Bordetella pertussis, potency assays, challenge suspension.

ABSTRACT

Potency of pertussis component, present in DPT-vax, is evaluated by Kendrick assay. Strain Bordetella pertussis 18323 is recommended by WHO, which should be stored in a way that ensures its viability, purity and virulence. As part of the assay, the concentration of a strain suspension should be calculated, which opacity is compared at first sight with the Fifth Reference International Preparation of Opacity. This method is very inexact and frequently leads to errors. A seed lot from Bordetella pertussis 18323 was elaborated and characterized in this study and the concentration of the strain using a calibration curve was calculated. The lot was used in eight potency assays and they complied with established validity criterion.


REFERENCES

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  2. NIBSC. WHO international Standard Opacity 5IRP. London: NIBSC; 2008. Disponible en: Http://www.who.int/biologicals/en/

  3. Corbel MJ, Xing D. Toxicity and potency evaluation of pertussis vaccine. Expert Rev Vaccines 2004;3(1): 89-101.

  4. World Health Organization. Manual of laboratory methods for testing of vaccines used in the WHO Expanded Programme on Inmunization. Global programme for vaccines and inmunization. Vaccine supply and quality. Assay for testing the potency of whole cell pertussis vaccines in monovalent or combined form. Geneva: WHO; 1997.

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  6. WHO. Technical report series, no 961. WHO good practices for pharmaceutical microbiology laboratories. Annex 2. Geneva: WHO; 2011.

  7. Centro para el Control Estatal de la Calidad de los Medicamentos. Regulación 16-2012. Directrices sobre Buenas Prácticas de Fabricación de Productos Farmacéuticos. La Habana: CECMED; 2012.

  8. FDA. Code of Federal Regulations Title 21. General Biological Products Standards. Section 610.18 Cultures. Silver Spring, US: FDA; 2002.

  9. Perry SF. Freeze-drying and cryopreservation of bacteria. Molecular Biotechnology 1998;9:59-64.

  10. FDA. Preparation of freeze-dried cultures of Bordetella pertussis. Center for Biologics Evaluation and Reseach. Lab. of Pertussis. Silver Spring, US: FDA; 1992.

  11. Organización Mundial de la Salud. Serie de Informes Técnicos No. 594. Comité de Expertos de la OMS en Patrones Biológicos. 27° Informe. Ginebra: OMS; 1976.




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C?MO CITAR (Vancouver)

VacciMonitor. 2013;22