medigraphic.com
ISSN 1025-0298 (Electronic)
ISSN 1025-028X (Print)

2012, Number 2

<< Back

VacciMonitor 2012; 21 (2)

The risk analysis used to manufacture recombinant proteins in E. coli

García J, Santana Z, Zumalacárregui L, Quintana M, Milá L, Ramos M, Beldarraín A

Language: Spanish
References: 19
Page: 35-42
PDF size: 462.53 Kb.


ABSTRACT

In this paper a risk analysis management is applied using the Failure Mode Effects Analysis to the fermentation processes that use E. coli as a host, to produce recombinant proteins with therapeutic, vaccinate or diagnostic aims. The analysis of the type and probability of occurrence of failures in the fermentation process, the evaluation of the impact in the quality of the product and the probability of detection of these failures are carried out. The severity, occurrence probability and detection probability are evaluated and the risk priority number is calculated. Techniques used in Quality assurance as brainstorming and Ishikawa diagram were used. The potential causes that have higher influence in the failures of a fermentation process of recombinant E. coli are: inadequate handling during inoculation, presence of phages and unqualified personnel. Actions to minimize the risks are proposed.


REFERENCES

  1. García I. Diseño e implementación del Sistema de Análisis de Riesgo en el CIGB. [Tesis de Maestría]. La Habana, Cuba: Centro de Ingeniería Genética y Biotecnología; 2011.

  2. ICH Harmonised Tripartite Guideline Quality Risk Management Q9. Federal Register 2006;71:32105-6.

  3. Food and Drug Administration (FDA). Consensus Guideline. Quality Risk Management. Step 4, ICH Q9, USA; 2006.

  4. FMEA Severity, Occurrence, and Detection Definitions; 2006. Disponible en: http://healthcare.isixsigma.com/library/content/ c040317a.asp. Consultado: 6 de enero, 2012.

  5. International Electrotechnical Commission (IEC) 60812. Analysis Techniques for system reliability—Procedures for failure mode and effects analysis (FMEA). 2da. ed. Ginebra, Suiza: IEC; 2006.

  6. FDA. Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. USA: FDA; 2004.

  7. Bush L. From cGMPs to the Critical Path. FDA Focuses on Innovation, Quality, and Continuous Improvement - Inside and Out. Pharmaceutical Technology 2004;28(7):34–44.

  8. País Chanfrau JM. Establecimiento del espacio de diseño del proceso fermentativo de obtención de la insulina recombinante en Pichia pastoris. [Tesis Doctoral] La Habana, Cuba: Facultad de Ingeniería Química, ISPJAE; 2011.

  9. Fontanet Tamayo L. Contribución al enfoque de riesgo en la validación del procesamiento aséptico de vacunas mediante la simulación con medio de cultivo. [Tesis Doctoral]. La Habana, Cuba: Instituto de Farmacia y Alimentos, UH; 2008.

  10. Milá L, Valdés R, Padilla S, Mendoza O, Gómez L, García C, et al. Quality Risk Management Application Review in Pharmaceutical and Biopharmaceutical Industries. Bioprocessing Journal 2010;9(1):26-37.

  11. Bachmann BJ. Linkage Map of E. coli K-12, Edition 8. Microbiological Reviews 1990: 54(2): 130-197.

  12. Programa de Tecnología para diagnóstico e investigaciones SA. TDI-1D Manager para Windows, Versión 2 No DB3WV. Madrid; 1999. Disponible en: http://www.tdi.es/ . Consultado: 12 de enero, 2012.

  13. Kilikian BK, Suárez ID, Liria CW, Gombert AK. Process strategies to improve heterologous protein production inEscherichia coli under lactose or IPTG induction. Process Biochemistry 2000;35:1019-25.

  14. Lowry OH, Rosebrough NJ, Farr AL, Randall RJ. Protein measurement with the follin phenol reagent. J Biol Chem 1951;193:265-75.

  15. Valderrama S, Pérez E, Aldama Y, Costa L, Quintana M, Pérez G, et al. Establecimiento y validación de un ensayo inmunoenzimático tipo ELISA, empleado en el Control de Calidad del Interferón alfa 2b humano recombinante. Vaccimonitor 2009;18(1):8-14.

  16. Towbin H, Staehelin T, Gordon J. Electrophoretic transfer of proteins from polyacrylamide gels to nitrocellulose sheets: procedure and some applications. Proc Natl Acad Sci, USA, 1979;76:4350-4.

  17. Rathore AS. Application of Process Analytical Technology (PAT) towards bioprocessing. Am Pharm Rev 2009; 12(2):28- 33.

  18. European Commission. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Annex 1. Manufacture of sterile medicinal products. Brusels: European Commission; 2008. Vol 4:1-16.

  19. Miller AJ, Eblen BS, Oser A, Burkhardt W. Application and evaluation of male-specific bacteriophage as explosed integrity or faecal contamination indicator in a pork slaughterhouse environment. J of Appl Microbiology 1998;85:898-904.




2020     |     www.medigraphic.com