Automated alkaline lysis for industrial scale cGMP production of pharmaceutical grade plasmid-DNA

Journal of Biotechnology

Volumn 128, Issue 1, 2007, Pages 132-149

  Urthaler, Jochen ^a   Ascher, Christine ^a   Wöhrer, Helga ^a   Necina, Roman ^a  

^a BOEHRINGER INGELHEIM RCV GMBH AND CO KG   (Austria)

Author keywords

Alkaline lysis; Automation; Cell disintegration; DNA; Gene therapy; Industrial scale; Plasmid; Production; Quality

Indexed keywords

DEGRADATION; DNA; DRUG PRODUCTS; DRUG THERAPY; GENES; MIXING;

CELL DISINTEGRATION; GENE THERAPY; PLASMID;

GENETIC ENGINEERING;

CYCLIC GMP; PLASMID DNA; POLYNUCLEOTIDE;

ALKALINIZATION; ANALYTIC METHOD; ARTICLE; AUTOMATION; CHEMICAL DISINTEGRATION TECHNIQUE; CYTOLYSIS; DNA DETERMINATION; ESCHERICHIA COLI; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; PROCESS OPTIMIZATION; PRODUCT RECOVERY; SYNTHESIS;

AUTOMATION; BACTERIOLYSIS; CYCLIC GMP; DNA; ESCHERICHIA COLI; HYDROGEN-ION CONCENTRATION; INDUSTRIAL MICROBIOLOGY; PLASMIDS;

EID: 33845747210     PISSN: 01681656     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jbiotec.2006.08.018     Document Type: Article

References (59)

1. Asenjo J.A., and Andrews B.A. In: Asenjo J.A. (Ed). Separation Processes in Biotechnology (1990), Marcel Dekker, New York, NY
2. Bendall K.E., Duncan E., Griess E., and Schacht D. In: Bowien B., and Dürre P. (Eds). Nucleic Acids Isolation Methods (2003), American Scientific Publishers, Stevenson Ranch
3. Birnboim H.C., and Doly J. A rapid alkaline extraction procedure for screening recombinant plasmid DNA. Nucl. Acids Res. 7 6 (1979) 1513-1523
4. Birnboim H.C. A rapid alkaline extraction method for the isolation of plasmid DNA. Meth. Enzymol. 100 (1983) 243-255
5. Bridenbaugh, R., Dang, W., Bussey, L., 2000. WO Patent 00/05358.
6. Carlson A., Signs M., Liermann L., Boor R., and Jim Jem K. Mechanical disruption of Escherichia coli for plasmid recovery. Biotechnol. Bioeng. 48 (1995) 303-315
7. Chase H.A. Purification of proteins by adsorbtion chromatographyin expanded beds. Trends Biotechnol. 12 (1994) 296-303
8. Ciccolini L.A.S., Ayazi Shamlou P., Titchener-Hooker N.J., Ward J.M., and Dunnill P. Time course of SDS-alkaline lysis of recombinant bacterial cells for plasmid release. Biotechnol. Bioeng. 60 (1998) 768-770
9. Ciccolini L.A.S., Ayazi Shamlou P., and Titchener-Hooker N.J. A mass balance study to assess the extent of contaminant removal achieved in the operations for the primary recovery of plasmid DNA from Escherichia coli cells. Biotechnol. Bioeng. 77 (2002) 796-805
10. Cichutek K. DNA vaccines: development, standardization and regulation. Intervirology 43 (2000) 331-338
11. Cooke G.D., Cranenburgh R.M., Hanak J.A.J., Dunnill P., Thatcher D.R., and Ward J.M. Purification of essentially RNA free plasmid DNA using a modified Escherichia coli host strain expressing ribonuclease A. J. Biotechnol. 85 (2001) 297-304
12. Diogo H.M., Queiroz J.A., Monteiro G.A., and Prazeres D.M.F. Separation and analysis of plasmid denatured forms using hydrophobic interaction chromatography. Anal. Biochem. 275 (1999) 122-124
13. Falk L.A., and Ball L.K. Current status and future trends in vaccine regulation-USA. Vaccine 19 (2001) 1567-1572
14. Ferreira G.N.M., Cabral J.M.S., and Prazeres D.M.F. Development of process flow sheets for the purification of supercoiled plasmids for gene therapy applications. Biotechnol. Prog. 15 (1999) 725-731
15. Ferreira G.N.M., Cabral J.M.S., and Prazeres D.M.F. Anion exchange purification of plasmid DNA using expanded bed adsorption. Bioseparation 9 (2000) 1-6
16. Foster D. Cell disruption: breaking up is hard to do. Biotechnology (NY) 10 (1992) 1539-1541
17. Jansen J.-C., and Petterson T. Large Scale Chromatography of Proteins. In: Ganetsos G., and Parker P.E. (Eds). Preparative and Production Scale Chromatography (1993), Marcel Dekker, New York, NY 559-590
18. Kreuzer K.N., and Cozzarelli N.R. Formation and resolution of DNA catenanes by DNA gyrase. Cell 20 (1980) 245-254
19. Lee, A.L., Sagar, S., 1996. WO Patent 96/36706.
20. Levy M.S., Collins I.J., Yim S.S., Ward J.M., Titchener-Hooker N.J., Ayazi Shamlou P., and Dunnill P. Effect of shear on plasmid DNA in solution. Bioprocess. Biosyst. Eng. 20 (1999) 7-13
21. Levy M.S., Ciccolini L.A.S., Yim S.S., Tsai J.T., Titchener-Hooker N.J., Ayazi Shamlou P., and Dunnill P. The effects of material properties and fluid flow intensity on plasmid DNA recovery during cell lysis. Chem. Eng. Sci. 54 (1999) 3171-3178
22. Levy M.S., O'Kennedy R.D., Ayazi Shamlou P., and Dunnill P. Biochemical engineering approaches to the challenges of producing pure plasmid DNA. Trends Biotechnol. 18 (2000) 296-305
23. Levy M.S., Lotfian P., O'Kennedy R., Lo-Yim M.Y., and Ayazi Shamlou P. Quantitation of supercoiled circular content in plasmid DNA solutions using of fluorescence-based method. Nucl. Acids Res. 28 (2000) E57
24. Marquet M., Horn N.A., and Meek J.A. Process development for the manufacture of plasmid DNA vectors for use in gene therapy. BioPharm Sept. (1995) 26-37
25. Marquet M., Horn N.A., and Meek J.A. Characterization of plasmid DNA vectors for use in human. BioPharm May (1997) 42-50
26. Martin R. Gel Electrophoresis: Nucleic Acids (1996), Bios Scientific, London, UK
27. Middaugh C.R., Evans R.K., Mongomery D.L., and Casimiro D.R. Analysis of plasmid DNA from a pharmaceutical perspective. J. Pharm. Sci. 87 (1998) 130-146
28. Meacle F.J., Lander R., Ayazi Shamlou P., and Titchener-Hooker N.J. Impact of engineering flow conditions on plasmid DNA yield and purity in chemical cell lysis operations. Biotechnol. Bioeng. 87 (2004) 293-302
29. Nienow, A.W., Riley, G., Hitchcock, A.G., 2002. US Patent 6,395,516.
30. Prazeres D.M.F., Ferreira G.N.M., Monteiro G.A., Cooney C.L., and Cabral J.M.S. Large-scale production of pharmaceutical-grade plasmid DNA for gene therapy: problems and bottlenecks. Trends Biotechnol. 17 (1999) 169-174
31. Robertson J.S., and Cichutek K. European Union Guidance on the quality, safety and efficacy DNA vaccines and regulatory requirements. Dev. Biol. 104 (2000) 53-56
32. Rush M.G., and Warner R.C. Alkali denaturation of covalently closed circular duplex deoxy. J. Biol. Chem. 245 (1970) 2704-2708
33. Sambrook J., Fritsch E.F., and Maniatis T. Molecular Cloning: A Laboratory Handbook (1989), CSH Press, Cold Spring Harbor
34. Schleef M., Mountain A., Ney U.M., and Schomburg D. Biotechnology vol. 5a (1999), Wiley-VCH, Weinheim, D
35. Schumacher I., Freitag, R., Hilbrig, F., 2002. WO Patent 02/057446.
36. Sinden R.R., and Alkek A.B. DNA Structure and Function (1994), Academic Press, San Diego, CA pp. 95-133
37. Smith H.A. Regulatory considerations for nucleic acid vaccines. Vaccine 12 (1994) 1515-1519
38. Smith H.A. Regulatory and reviews of DNA vaccine products. Dev. Biol. 104 (2000) 57-62
39. Smith H.A. The regulation of DNA vaccines. Curr. Opin. Biotechnol. 12 (2001) 299-303
40. Sofer G., and Hagel L. In: Sofer G. (Ed). Handbook of Process Chromatography, A Guide to Optimization, Scale-up, and Validation (1997), Academic Press, London, UK pp. 10-12, pp. 43-54, pp. 132-172
41. Strick T.R., Allemand J.-F., Bensimon D., and Croquette V. Behavior of supercoiled DNA. Biophys. J. 74 (1998) 2016-2028
42. Summers D.K. The Biology of Plasmids (1996), Blackwell Science Oxford, UK
43. Theodossiou I., Collins I.C., Ward J.M., Thomas O.R.T., and Dunnill P. The processing of a plasmid-based gene from Escherichia coli primary recovery by filtration. Bioprocess. Biosyst. Eng. 16 (1997) 175-783
44. Theodossiou I., Thomas O.R.T., and Dunnill P. Methods of enhancing the recovery of plasmid genes from neutralised cell lysate. Bioprocess. Biosyst. Eng. 20 (1999) 147-156
45. Urthaler, J., Necina, R., Ascher, C., Wöhrer, H., 2004. WO Patent 2004/085643.
46. Urthaler J., Schlegl R., Podgornik A., Strancar A., Jungbauer A., and Necina R. Application of monoliths for plasmid DNA purification. Development and transfer to production. J. Chromatogr. A 1065 (2005) 93-106
47. Urthaler J., Buchinger W., and Necina R. Improved downstream process for the production of plasmid DNA for gene therapy. Acta Biochim. Pol. 52 (2005) 703-711
48. Urthaler J., Buchinger W., and Necina R. Industrial scale cGMP purification of pharmaceutical grade plasmid-DNA. Chem. Eng. Technol. 28 (2005) 1408-1420
49. US FDA. Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications (1996), US Food and Drug Administration, Rockville, MD
50. US FDA. Hum. Gene Ther. 7 (1996) 1181-1190
51. US FDA. Addendum to The Points to Consider in Human Somatic Cell and Gene Therapy (1996), US Food and Drug Administration, Rockville, MD
52. US FDA. Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy (1998), US Food and Drug Administration, Rockville, MD
53. Varley D.L., Hitchkock A.G., Weiss A.M.E., Horler W.A., Cowell R., Peddie L., Sharpe G.S., Thatcher D.R., and Hanak J.A.J. Production of plasmid DNA for human gene therapy using modified alkaline cell lysis and expanded bed anion exchange chromatography. Bioseparation 8 (1999) 209-217
54. Wan N.C., McNeilly, D.S., Christopher, C.W., 1996. US Patent 5,837,529.
55. Weir N. Non-Viral Vectors for Gene Therapy. In: Mountain A., Ney U.M., and Schomburg D. (Eds). Biotechnology. 2nd ed. vol. 5a (1999), Wiley-VCH, Weinheim 427-442
56. Werner R.G., Urthaler J., Kollmann F., Huber H., Necina R., and Konopitzky K. pDNA-from process science to commercial manufacture. Contract Services Europe. Pharm. Technol. Eur. 3 Suppl. (2002) 34-38
57. WHO. Biologicals 26 (1998) 205
58. Wicks I.P., Howell M.L., and Hancock T. Bacterial lipopolisaccharide copurifies with plasmid DNA: implications for animal models and human gene therapy. Hum. Gene Ther. 6 (1995) 317-323
59. Wright, J.L., Wurm, F.M., 2002. WO Patent 02/26966.