Pharmaceutical grade large-scale plasmid DNA manufacturing process

Methods in Molecular Biology

Volumn 1143, Issue , 2014, Pages 219-240

  Schmeer, Marco ^a   Schleef, Martin ^a  

^a NONE

Author keywords

High Quality Grade DNA; Plasmid DNA manufacturing; Plasmid quality control; Scale up

Indexed keywords

DNA VACCINE; PLASMID DNA; VIRUS VECTOR;

ARTICLE; ESCHERICHIA COLI; GENE TRANSFER; GOOD MANUFACTURING PRACTICE; HUMAN; LABORATORY; LARGE SCALE PRODUCTION; PHARMACEUTICS; PRIORITY JOURNAL; QUALITY CONTROL; SCALE UP; STANDARD; VACCINE PRODUCTION; BATCH CELL CULTURE; GENE VECTOR; ISOLATION AND PURIFICATION; PLASMID; PROCEDURES; STANDARDS;

BATCH CELL CULTURE TECHNIQUES; GENETIC VECTORS; PLASMIDS; VACCINES, DNA;

EID: 84921260561     PISSN: 10643745     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-4939-0410-5_14     Document Type: Article

References (45)

1. Lederberg J (1952) Cell genetics and hereditary symbiosis. Physiol Rev 32:403–430
2. Lahijani R, Hulley G, Soriano G et al (1996) High-yield production of pBR322-derived plasmids intended for human gene therapy by employing a temperature-controllable point mutation. Hum Gene Ther 7:1971–1980
3. Schmidt T, Friehs K, Flaschel E et al (1998) Method for the isolation of ccc plasmid DNA. WO 1999/061633
4. Carnes AE, Hodgson CP, Williams JA (2006) Inducible Escherichia coli fermentation for increased plasmid DNA production. Biotechnol Appl Biochem 45:155–166
5. Hoare M, Levy MS, Bracewell DG et al (2005) Bioprocess engineering issues that would be facing in producing a DNA vaccine at up to 100 m 3 fermentation scale for an influenza pandemic. Biotechnol Prog 2005(21): 1577–1592
6. Birnboim HC, Doly J (1979) A rapid alkaline extraction procedure for screening recombinant plasmid DNA. Nucleic Acids Res 7:1513–1523
7. Maucksch C, Connor B, Rudolph C (2013) Plasmid DNA concatemers: influence of plasmid structure on transfection efficiency. In: Schleef M (ed) Minicircle and miniplasmid DNA vectors—the future of non-viral and viral gene transfer. Wiley-Blackwell, Weinheim
8. Wooddell CI, Subbotin VM, Sebestyén MG et al (2011) Muscle damage after delivery of naked plasmid DNA into skeletal muscles is batch dependent. Hum Gene Ther 22: 225–235
9. Schmidt T, Friehs K, Schleef M, Voss K, Flaschel E (1999) Quantitative analysis of plasmid forms by agarose and capillary gel electrophoresis. Anal Biochem 274:235–240
10. Schleef M, Schmidt T (2004) Animal-free production of ccc-supercoiled plasmids for research and clinical applications. J Gene Med 6:S45–S53
11. Schleef M, Baier R, Walther W et al (2006) Long-term stability and topology analysis of plasmid DNA by capillary gel electrophoresis. Bioprocess Int 4:38–40
12. Janshoff A, Neitzert M, Oberdorfer Y et al (2000) Force spectroscopy of molecular systems-single molecule spectroscopy of polymers and biomolecules. Angew Chem Int Ed Engl 39(18):3212–3237
13. Binnig G, Quate CF, Gerber C (1986) Atomic force microscope. Phys Rev Lett 56(9):930–933
14. Drake B, Prater CB, Weisenhorn AL et al (1989) Imaging crystals, polymers, and processes in water with the atomic force microscope. Science 243(4898):1586–1589
15. Rischmüller A, Viefhues M, Dieding M et al (2013) Analytic tools in minicircle production. In: Schleef M (ed) Minicircle and miniplasmid DNA vectors—the future of non-viral and viral gene transfer. Wiley-Blackwell, Weinheim
16. Viefhues M, Wegener S, Rischmüller A, Schleef M, Anselmetti D (2013) Dielectrophoresis based continuous-flow nano sorter: fast quality control of gene vaccines. Lab Chip 13: 3111–3118
17. EMEA (2005) Guideline on development and manufacture of lentiviral vectors. CPMP/ BWP/2458/03, London
18. EMEA (2001) Note for guidance on the quality, preclinical and clinical aspects of gene transfer medical products. CPMP/BWP/ 3088/99, London
19. Gengenbach RJ (2008) GMP-Qualifizierung und Validierung von Wirkstoffanlagen. Wiley-VCH, Weinheim
20. Schmidt T, Schleef M, Friehs K, Flaschel E (1999) Hochzelldichtefermentation zur Gewinnung von Plasmid-DNA für Gentherapie und genetische Impfung. BIOforum 22: 174–177
21. Lee SY, Chang HN (1994) High cell density cultivation of Escherichia coli using sucrose as a carbon source. Biotechnol Lett 15:971–974
22. Nakano K, Rischke M, Sato S, Märkl H (1997) Influence of acetic acid on the growth of Escherichia coli K12 during high-cell-density cultivation in a dialysis reactor. Appl Microbiol Biotechnol 48:597–601
23. Macaloney G, Hall JW, Rollins MJ et al (1997) The utility and performance of near-infrared spectroscopy in simultaneous monitoring multiple components in a high cell density recombinant Escherichia coli production process. Bioproc Eng 17:157–167
24. Paalme T, Tiisma K, Kahru A et al (1990) Glucose-limited fed-batch cultivation of Escherichia coli with computer-controlled fixed growth rate. Biotechnol Bioeng 35:312–319
25. EMEA (2001) Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. CPMP/410/01 rev 1, London
26. Voss C, Schmidt T, Schleef M et al (2004) Effect of ammonium chloride on plasmid DNA production in high cell density batch culture for biopharmaceutical use. J Chem Technol Biotechnol 79:57–62
27. Urthaler J, Buchinger W, Necina R (2005) Improved downstream process for the production of plasmid DNA for gene therapy. Acta Biochim Pol 52:703–711
28. Levy MS, Collins IJ, Tsai JT et al (2000) Removal of contaminant nucleic acids by nitrocellulose filtration during pharmaceuticalgrade plasmid DNA processing. J Biotechnol 76:197–205
29. Schleef M (1999) Issues of large-scale plasmid manufacturing. In: Rehm HJ, Reed G, Pühler A et al (eds) Biotechnology, vol 5a, Recombinant proteins, monoclonal antibodies and therapeutic genes. Wiley-VCH, Weinheim, pp 443–470
30. Lee AL, Sagar S (1999) A method for large scale plasmid purification. WO 96/36706
31. Schumacher I, Freitag R, Hilbrig F (2002) Method for treating biomass for producing cell lysate containing plasmid DNA. WO 02/057446 A2
32. Hebel H, Ramakrishnan S, Gonzales H et al (2004). Devices and methods for biomaterial production. WO2004/108260
33. Voß C, Schmidt T, Schleef M (2005) From bulk to delivery: plasmid m, manufacturing and storage. In: Schleef M (ed) DNA pharmaceuticals: formulation and delivery in gene therapy, DNA vaccination and immunotherapy. Wiley-VCH, Weinheim, pp 23–42
34. Voss C, Flaschel E (2010) Method for producing extra-chromosomal nucleic acid molecules. US 7,842,481 B2
35. Colpan M, Schorr J, Moritz P (1995) Process for producing endotoxin-free or endotoxinpoor nucleic acids and/or oligonucleotides for gene therapy. WO 95/21177
36. Thatcher DR, Hitchcock AG, Hanak JA et al (1997) Method of plasmid DNA production and purification. WO 97/29190
37. Bussey L, Adamson R, Atchley A (1998) Methods for purifying nucleic acids. WO 98/05673
38. Ferreira GNM, Prazeres DMF, Cabral JMS et al (2001) Plasmid manufacturing—an overview. In: Schleef M (ed) Plasmids for therapy and vaccination. Wiley-VCH, Weinheim, pp 193–236
39. Green AP (1999) Purification of supercoiled plasmid. In: Lowrie DB, Whalen RG (eds) DNA vaccines: methods and protocols. Humana, Totowa, NJ, pp 1–9
40. Lemmens R, Olsson U, Nyhammar T et al (2003) Supercoiled plasmid DNA: selective purification by thiophilic/aromatic adsorption. J Chromatogr B 784:291–300
41. Strancar A, Podgornik A, Barut M et al (2002) Short monolithic columns as stationary phases for biochromatography. Adv Biochem Eng Biotechnol 76:49–85
42. Schleef M (ed) (2013) Minicircle and miniplasmid DNA vectors—the future of non-viral and viral gene transfer. Wiley-Blackwell, Weinheim
43. Preston A (2003) Choosing a cloning vector. In Casali N, Preston A (eds) E. coli plasmid vectors. Humana Press, Totowa NJ, pp 19–26. Gene Ther 22:225-235
44. Schwarz B, Kempf T, Schillinger U et al (2007) Cloning of the feline cytokines IL-2, IFNy and GM-CSF for an adjuvant nonviral gene therapy of feline fibrosarcoma. Kleintierpraxis 52:569–578
45. Schleef M, Blaesen M (2009) Production of plasmid DNA as a pharmaceutical. In: Walther W, Stein US (eds) Methods in molecular biology, vol 542, Gene therapy of cancer., pp 471–495