del Puerto-Sardiñas CA, Hernández-Fundora M, González-Rodríguez H, Leyva-Rodríguez AL, Baños-Paiffer N, Fernández-Esperón IM, Cruz-Ferrer A, Martínez-Rivera R

Language: Spanish
References: 11
Page: 1-4
PDF size: 101.57 Kb.

ABSTRACT

During the manufacturing of biological products derived from microorganisms, stable and well-characterized cells to be used as production source should be provided. In this sense, it is essential to preserve strains using Seed Lot System as well as to have culture media ensuring an optimal growth of microorganisms and the presence of the relevant antigens. Currently, Finlay Institute from Havana works in obtaining a free- from-animal-origin-component vaccine against Neisseria meningitidis serogroups A, C, Y and W. Reference and Working Seed Lots from Neisseria meningitidis serogroups A, C, Y, W and X were developed and characterized, using culture media free from animal-origin components and in compliance with current Good Manufacturing Practices. New documentation was established, including: lot master files, standard operational procedures, lot records, quality control specifications and assay certificates.

REFERENCES

1. ICH Harmonised Tripartite Guideline. Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products. International Conference on Harmonisation of Technical requirements for Registration of Pharmaceuticals for Human Use. Geneva: ICH; 1997.

2. 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.

3. WHO. Recommendations to assure the quality, safety and effi cacy of group A meningococcal conjugate vaccines. Geneva: WHO; 2006.

4. Martínez I. Neisserias y Moraxella catarrhalis. En: Llop A, Valdés-Dapena M, Zuazo JL et al. Microbiología y Parasitología Médicas. La Habana: Editorial Ciencias Médicas; 2001. p. 217- 38.

5. WHO. Annex 4. Good Manufacturing Practices for pharmaceutical products: main principles. WHO Technical Report Series No. 908. Geneva: WHO; 2003.

6. WHO. Annex 2. WHO good practices for pharmaceutical microbiology laboratories. WHO Technical Report Series No. 961. Geneva: WHO; 2011.

7. FDA. Code of Federal Regulations, Title 21. Part 610. General Biological Products Standards. Section 610.18 Cultures. Silver Spring, US: FDA; 2002.

8. Pharmaceutical Inspection Convention. Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products. PH 1/97 (Rev. 3). Geneva: PIC/S; 2002.

9. Cody WL, Wilson JW, Hendrixson DR, McIver KS, Hagman KE, Ott CM, Nickerson CA, Schurr MJ. Skim milk enhances the preservation of thawed -80ºC bacterial stocks. Journal of Microbiological Methods 2008;75:135-8.

10. Dumont F, Marechal PA, Gervais P. Cell size and water permeability as determining factors for cell viability after freezing at different cooling rates. Appl. Environ. Microbiol 2004;70:268-72.

11. Martínez I. Enfermedad meningocóccica. Diagnóstico microbiológico. En: Ochoa RF, Sierra G, Martínez I, Cuevas I. Prevención de la enfermedad meningocócicca. La Habana: Finlay Ediciones; 2010. p. 3-27.