Large-scale production of pharmaceutical-grade plasmid DNA for gene therapy: Problems and bottlenecks

Trends in Biotechnology

Volumn 17, Issue 4, 1999, Pages 169-174

  Prazeres, Duarte M F ^a   Ferreira, Guilherme N M ^a   Monteiro, Gabriel A ^a   Cooney, Charles L ^b   Cabral, Joaquim M S ^a  

^a INSTITUTO SUPERIOR TÉCNICO   (Portugal)

^b USA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLASMID DNA; RECOMBINANT PROTEIN;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CYSTIC FIBROSIS; DNA MODIFICATION; DNA PURIFICATION; FERMENTATION; GENE THERAPY; HUMAN; MOLECULAR WEIGHT; PRIORITY JOURNAL; PROCESS CONTROL; SHORT SURVEY;

EID: 0033120652     PISSN: 01677799     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0167-7799(98)01291-8     Document Type: Review

References (30)

1. Anderson, W. F. (1992) Science 256, 808-813
2. Robinson, H. L., Ginsberg, H. S., Davis, H. L., Johnston, S. A. and Liu, M. A. (1997) The Scientific Future of DNA for Immunization, American Society of Microbiology, Washington, DC, USA
3. Glaser, V. (1997) Genet. Eng. News 14, 14 & 33-34
4. Robbins, P. D., Tahara, H. and Ghivizzani, C. (1998) Trends Biotechnol. 16, 35-40
5. Ledley, F. (1995) Hum. Gene Ther. 6, 1129-1144
6. Marcel, T. and Grausz, J. D. (1997) Hum. Gene Ther. 8, 775-800
7. Nabel, G. J. et al. (1995) Ann. New York Acad. Sci. 772, 227-231
8. US Food and Drug Administration (1996) Addendum to the Points to Consider in Human Somatic Cell and Gene Therapy, US Food and Drug Administration, Rockville, MD, USA
9. US Food and Drug Administration (1996) Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications, US Food and Drug Administration, Rockville, MD, USA
10. Anicetti, V. R., Keyt, B. A. and Hancock, W. S. (1989) Trends Biotechnol. 7, 342-349
11. WHO Expert Committee on Biological Standardization (1998) WHO Technical Report Series No. 878, World Health Organization, Geneva, Switzerland
12. Sofer, G. and Hagel, L. (1997) Handbook of Process Chromatography: A Guide to Optimization, Scale-up and Validation (1st Edn), Academic Press
13. Horn, N. A., Meek, J. A., Budahazi, G. and Marquet, M. (1995) Hum. Gene Ther. 6, 565-573
14. Wicks, I. P., Howell, M. L., Hancock, T., Kohsaka, H., Olee, T. and Carson, D. A. (1995) Hum. Gene Ther. 6, 317-323
15. Marquet, M., Horn, N. C. and Meek, J. A. (1997) BioPharm May, 42-50
16. Lahijani, R., Hulley, G., Soriano, G., Horn, N. A. and Marquet, M. (1996) Hum. Gene Ther. 7, 1971-1980
17. Kumar, P. K. R., Maschke, H-E. and Schügerl, K. (1991) Trends Biotechnol 9, 279-284
18. Marquet, M., Horn, N. A. and Meek, J. A. (1995) BioPharm September, 26-37
19. Carlson, A., Signs, M., Liermann, L., Boor, R. and Jem, K. J. (1995) Biotechnol. Bioeng. 48, 303-315
20. Birnboim, H. C. and Doly, J. (1979) Nucleic Acids Res. 7, 1513-1523
21. Prazeres, D. M. F., Schluep, T. and Cooney, C. L. (1998) J. Chromatog. A 806, 31-45
22. Rush, M. G. and Warner, R. C. (1970) J. Biol. Chem. 245, 2704-2708
23. Stephenson, D., Norman, F. and Cumming, R. H. (1993) Bioseparation 3, 285-289
24. Oldshue, J. Y. and Bajpai, R. K. (1991) in Recombinant DNA Technology and Applications (Prokop, A., Bajpai, R. K. and Ho, C., eds), pp. 460-476, McGraw-Hill
25. Theodossiou, I., Collins, I. J., Ward, J. M., Thomas, O. R. T. and Dunnill, P. (1997) Bioprocess Eng. 16, 175-183
26. Lis, J. T. and Schleif, R. (1975) Nucleic Acids Res. 2, 383-389
27. Ferreira, G. N. M., Cabral, J. M. S. and Prazeres, D. M. F. (1997) Biotechnol. Tech. 11, 417-420
28. Green, A. P., Prior, G. M., Helveston, N. M., Taittinger, B. E., Liu, X. and Thompson, J. A. (1997) BioPharm May, 52-62
29. Wils, P. et al. (1997) Gene Ther. 4, 323-330
30. Schluep, T. and Cooney, C. L. (1998) Nucleic Acids Res. 26, 4524-4528