Plasmid DNA Manufacturing Technology

Recent Patents on Biotechnology

Volumn 1, Issue 2, 2007, Pages 151-166

  Carnes, Aaron E ^a   Williams, James A ^a  

^a NATURE TECHNOLOGY CORPORATION   (United States)

Author keywords

alkaline lysis; DNA vaccine; downstream processing; fermentation; gene therapy; Plasmid; purification

Indexed keywords

BIOMOLECULES; DNA; PATENTS AND INVENTIONS; PURIFICATION; VACCINES;

ALKALINE LYSE; ALKALINES; BIOTECHNOLOGY PRODUCTS; DNA VACCINE; DOWNSTREAM-PROCESSING; GENE MEDICINE; MANUFACTURING TECHNOLOGIES; PLASMID; PLASMID DNA; PRODUCT GENE;

GENE THERAPY;

DNA; DNA VACCINE;

BIOSYNTHESIS; BIOTECHNOLOGY; CHEMISTRY; EUROPE; FOOD AND DRUG ADMINISTRATION; ISOLATION AND PURIFICATION; LEGAL ASPECT; LICENSING; METHODOLOGY; PATENT; PLASMID; REVIEW; UNITED STATES;

BIOTECHNOLOGY; DNA; EUROPE; LICENSURE; PATENTS AS TOPIC; PLASMIDS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VACCINES, DNA;

EID: 58149141017     PISSN: 18722083     EISSN: 22124012     Source Type: Journal    
DOI: 10.2174/187220807780809436     Document Type: Article

References (180)

1. Fedson D. Preparing for pandemic vaccination: an international policy agenda for vaccine development. J Public Health Policy 2005; 26: 4-29.
2. Forde GM. Rapid-response vaccines-does DNA offer a solution? Nat Biotechnol 2005; 23: 1059-1062.
3. Drape RJ, Macklin MD, Barr LJ, Jones S, Haynes JR, Dean HJ. Epidermal DNA vaccine for influenza is immunogenic in humans. Vaccine 2006; 24:4475-4481.
4. Hoare M, Levy S, Bracewell DG, et al. Bioprocess engineering issues that would be faced in producing a DNA vaccine at up to 100 m3 fermentation scale for an influenza pandemic. Biotechnol Prog 2005; 21:1577-1592.
5. Carnes AE, Williams JA. Unpublished observations
6. Bichara M, Schumacher S, Fuchs RP. Genetic instability within monotonous runs of CpG sequences in Escherichia coli. Genetics 1995; 140:897-907.
7. Cooke JR, McKie EA, Ward JM, Keshavarz-Moore. Impact of intrinsic DNA structure on processing of plasmids for gene therapy and DNA vaccines. J Biotechnol 2004; 114: 239-254.
8. Kato M. Polypyrimidine/polypurine sequence in plasmid DNA enhances formation of dimer molecules in Escherichia coli. Dimerization of plasmid DNA in Escherichia coli. Mol Biol Rep. 1993; 18:183-187.
9. Levy, J.: US20046709844 (2004).
10. Leite JP, Cousin C, Heysen A, D'Halluin JC. Negative effect of a cis-acting pBR322 element on adenovirus E1a gene expression. Gene 1989; 82:351-356.
11. Peterson DO, Beifuss KK, Morley KL. Context-Dependent Gene expression: cis-acting negative effects of specific prokaryotic plasmid sequences on eukaryotic genes. Molec Cell Biol 1987; 7:1563-1567.
12. Tully DB, Cidlowski JA. pBR322 contains glucocorticoid regulatory element DNA consensus sequences. Biochem Biophys Res Commun 1987; 144:1-10.
13. Ghersa P, Whelan J, Pescini R, DeLamarter JF, Hooft van Huijsduijnen R. Commonly used cat reporter vectors contain a cAMP-inducible, cryptic enhancer that co-operates with NF-kappa B-sites. Gene 1994; 151:331-2.
14. Kushner PJ, Baxter JD, Duncan KG, Lopez GN, Schaufele F, Uht RM, Webb P, West BL. Eukaryotic regulatory elements lurking in plasmid DNA: the activator protein-1 site in pUC. Mol Endocrinol 1994; 8:405-7.
15. Williams JA, Luke J, Johnson L, Hodgson C. pDNAVACCultra vector family: high throughput intracellular targeting DNA vaccine plasmids. Vaccine 2006; 24: 4671-4676.
16. Williams, JA.: WO06078979 (2006).
17. Food and Drug Administration, Center for Biologics Evaluation and Research. 2005. Draft Guidance for industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications Docket No. 2005D-0047.
18. Food and Drug Administration, Center for Biologics Evaluation and Research. 1998. Guidance for industry: Guidance for human somatic cell therapy and gene therapy.
19. th meeting of ECBS, October (2005).
20. European Medicines Agency. 2001. Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products. CPMP/BWP/3088/99.
21. Schalk JAC, Mooi FR, Berbers GAM, van Aerts LAGJM, Ovelgonne H, Kimman TG. Preclinical and clinical safety studies on DNA vaccines. Human Vaccines 2006; 2: 45-53.
22. Glenting J. Wessels S. Ensuring safety of DNA vaccines. Microbial Cell Factories 2005; 4:26-31.
23. Snyder, L.A., Satishchandran, C.: US5851804 (1998)
24. Chiang CS, Bremer H. Stability of pBR322-derived plasmids. Plasmid 1988; 20:207-220.
25. Valenzuela MS, Siddiqui KA, Sarkar BL. High expression of plasmid-encoded tetracycline resistance gene in E. coli causes a decrease in membrane-bound ATPase activity. Plasmid 1996; 36:19-25.
26. Valenzuela MS, Ikpeazu EV, Siddiqui KA. E. coli growth inhibition by a high copy number derivative of plasmid pBR322. Biochem Biophys Res Commun. 1996; 219:876-883.
27. Eastman, E.M., Durland, R.H.: US20006103470 (2000).
28. Williams, S., Hanak, J.A. and Sherratt, D.J.: US5972708 (1999).
29. Cranenburgh RM, Hanak JA, Williams SG, Sherratt DJ. Escherichia coli strains that allow antibiotic-free plasmid selection and maintenance by repressor titration. Nucleic Acids Res. 2001; 29:E26.
30. Food and Drug Administration, Center for Biologics Evaluation and Research 1993 Points to consider in the characterization of cell lines used to produce biologics.
31. Acceptability of cell substrates for production of biologicals. Report of a WHO Study Group Geneva, World Health Organization 1987 (WHO Technical report series No. 747).
32. WHO Expert Committee on Biological standardization (1998) WHO Technical report series No. 878 World Health Organization.
33. Prather KL, Edmonds MC, Herod JW. Identification and characterization of IS1 transposition in plasmid amplification mutants of E. coli clones producing DNA vaccines. Appl Microbiol Biotechnol 2006; 73:815-26.
34. rd, Feher T, Frish D, Keil GM, Umenhoffer K, Kolisnychenko V, Stahl B, Sharma SS, de Arruda M, Burland V, Harcum SW, Blattner FR. Emergent properties of reduced-genome Escherichia coli. Science 2006; 312: 1044-1046.
35. Blattner, F.R., Plunkett, G., Posfai, G.: WO07024756 (2007).
36. Chen, Y., Kendirgi, F.: WO06063355 (2006).
37. Prather KJ, Sagar S, Murphy J, Chartrain M. Industrial scale production of plasmid DNA for vaccine and gene therapy: plasmid design, production and purification. Enzyme Microbial Technol 2003; 33: 865-883.
38. Carnes A.E. Fermentation design for the manufacture of therapeutic plasmid DNA. BioProcess Intl 2005; 3:36-44.
39. US Food and Drug Administration. Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications, US Food and Drug Administration, 1996 Rockville, MD, USA.
40. Crouzet, J., Soubrier, F.: US2001014476 (2001).
41. Soubrier F, Laborderie B, Cameron B. Improvement of pCOR plasmid copy number for pharmaceutical applications. Appl Microbiol Biotechnol 2005; 66: 683-686.
42. Lin-Chao S, Bremer H. Effect of the bacterial growth rate on replication control of plasmid pBR322 in Escherichia coli. Mol Gen Genet 1986; 203: 143-149.
43. O’Kennedy RD, Baldwin C, Keshavarz-Moore E. Effects of growth medium selection on plasmid DNA production and initial processing steps. J Biotechnol 2000: 76: 175-183.
44. Dorman CJ, Barr GC, Bhriain NN, Higgins CF. DNA supercoiling and the anaerobic and growth phase regulation of tonB gene expression. J Bacteriol 1988; 179: 2816-2826.
45. Goldstein E. Drlica K. Regulation of bacterial DNA supercoiling: plasmid linking numbers vary with growth temperature. Proc Natl Acad Sci USA 1984; 81: 4046-4050.
46. Hopkins D J, Betenbaugh MJ, Dhurjati P. Effects of dissolved oxygen shock on the stability of recombinant Escherichia coli containing plasmid pKN401. Biotechnol Bioeng 1987; 29: 85-91.
47. Namdev PK, Irwin N, Thompson BG, Gray MR. Effect of oxygen fluctuations on recombinant Escherichia coli fermentation. Biotechnol Bioeng 1993; 41: 666-670.
48. Durland RH, Eastman EM. Manufacturing and quality control of plasmid-based gene expression systems. Adv Drug Deliver Rev 1998; 30: 33-48.
49. Lahijani R, Hulley G, Soriano G, Horn NA, Marquet M. High-yield production of pBR322-derived plasmids intended for human gene therapy by employing a temperature-controllable point mutation. Hum Gene Ther 1996; 7: 1971-1980.
50. Chen, W.: US5955323 (1999).
51. Schmidt, T., Friehs, K., Flaschel, E., Schleef, M.: US20036664078 (2003).
52. Chartrain, M., Bentley, L.K., Krulewicz, B.A., Listner, K.M., Sun, W., Lee, C.B.: WO05078115 (2005).
53. Listner K, Bentley, LK, Chartrain M. A simple method for the production of plasmid DNA in bioreactors. Methods Mol Med 2006; 127:295-309.
54. Listner K, Bentley L, Okonkowski J, Kistler C, Wnek R, Caparoni A, Junker B, Robinson D, Salmon P, Chartrain M. Development of a highly productive and scalable plasmid DNA production platform. Biotechnol Prog 2006; 22:1335-45.
55. Huber, H., Weigl, G., Buchinger, W.: WO05097990 (2005).
56. Huber, H., Pacher, C., Necina, R., Kollmann, F., Reinisch, C.: WO05098002 (2005).
57. Lawther RP, Calhoun DH, Adams CW, Hauser CA, Gray J, Hatfield GW. Molecular basis of valine resistance in Escherichia coli K-12. Proc Natl Acad Sci USA 1981; 78:922-5.
58. Andersen DC, Swartz J, Ryll T, Lin N, Snedecor B. Metabolic oscillations in an E. coli fermentation. Biotechnol Bioeng 2001; 75:212-8.
59. Wegrzyn G. Replication of plasmids during bacterial response to amino acid starvation. Plasmid 1999; 41:1-16.
60. Carnes, A.E., Williams, J.A.: WO06023546 (2006).
61. Carnes, AE, Hodgson CP, Williams JA. Inducible Escherichia coli fermentation for increased plasmid DNA production. Biotechnol Appl Biochem 2006; 45:155-66.
62. Plasmid DNA for vaccine manufacture: high-yield production and rapid analysis. Downstream 41: 8-11. 2007 General Electric Company.
63. nd ed. 2003. Burlington MA: Butterworth-Heinemann.
64. Birnboim HC, Doly J. A rapid alkaline extraction procedure for screening recombinant plasmid. DNA. Nucleic Acids Res 1979; 7:1513-23.
65. Eon-Duval A, Gumbs K, Ellett C. Precipitation of RNA impurities with high salt in a plasmid DNA purification process: use of experimental design to determine reaction conditions. Biotechnol Bioeng 2003; 83: 544-553.
66. Shamlou PA. Scaleable processes for the manufacture of therapeutic quantities of plasmid DNA. Biotechnol. Appl Biochem 2003; 37: 207-218.
67. Levy MS, O’Kennedy R, Shamlou PA, Dunnill P. Biochemical engineering approaches to the challenges of producing pure plasmid DNA. Trends Biotechnol 2000; 18: 296-305.
68. Ferreira GN, Cabral JM, Prazeres DM. Development of process flow sheets for the purification of supercoiled plasmids for gene therapy applications. Biotechnol Prog 1999; 15: 725-731.
69. Ciccolini LAS, Shamlou PA, Titchener-Hooker N. A mass balance study to assess the extent of contaminant removal achieved in the operations for the primary recovery of plasmid DNA freom Escherichia coli cells. Biotechnol Bioeng 2002; 77: 796-805.
70. Ciccolini LA, Shamlou PA, Titchener-Hooker NJ, Ward JM, Dunnill P. Time course of SDS-alkaline lysis of recombinant bacterial cells for plasmid release. Biotechol Bioeng 1998; 60: 768-770.
71. Thatcher, D.R., Hitchcock, A., Hanak, J.A.J., Varley, D.: US20036503738 (2003).
72. Nienow, A.W., Hitchock, A.G., Riley, G.L.: US20026395516 (2002).
73. Wan, N.C., McNeilly, D.S., Christopher, C.W.: US5837529 (1998).
74. Chevalier, M.: US20036664049 (2003).
75. Detraz, N.J.F., Rigaut, G.: WO06060282 (2006).
76. Brooks, R.C.: US20046699706 (2004).
77. Blanche, F., Couder, M., Maestrali, N., Gaillac, D., Guillemin, T.: WO05026331 (2005).
78. Horn NA, Meek JA, Budahazi G, Marquet M. Cancer gene therapy using plasmid DNA: purification of DNA for human clinical trials. Hum Gene Ther 1995; 6: 565-573
79. Chamsart S, Patel H, Hanak JAJ, Hitchcock AG, Nienow AW. The impact of fluid-dynamic-generated stresses on chDNA and pDNA stability during alkaline cell lysis for gene therapy products. Biotechnol Bioeng 2001; 75:387-92.
80. Lengsfeld CS, Anchordoquy TJ. Shear-induced degradation of plasmid DNA. J Pharm Sci 2002; 91:1581-1589.
81. Hebel, H., Ramakrishnan, S., Gonzalez, H., Darnell, J.: WO04108260 (2004).
82. Urthaler, J., Necina, R., Ascher, C., Woehrer, H.: WO04085643 (2004).
83. Urthaler J, Ascher C, Wöhrer H, Necina R. Automated alkaline lysis for industrial scale cGMP production of pharmaceutical grade plasmid-DNA. J Biotechnol 2007; 128:132-149.
84. Holmes DS, Quigley M. A rapid boiling method for the preparation of bacterial plasmids. Anal Biochem 1981; 114:193-7.
85. Lee, A.L., Sagar, S.: US20016197553 (2001).
86. Jem, K.J.: US20026455287 (2002).
87. Willson, R.C., Murphy, J.C.: US2002197637 (2002).
88. Murphy JC, Cano T, Fox GE, Willson RC. Compaction agent protection of nucleic acids during mechanical lysis. Biotechnol Prog 2006; 22:519-22.
89. Boyd, D.B., Kristopeit, A.J., Lander, R.J., Murphy, J.C., Winters, M.A.: WO06083721 (2006).
90. Leung, W.S., Swartz, J.R.: US20016258560 (2001).
91. Jia, X., Kostal, J., Claypool, J.A.: US2006040393 (2006).
92. Cooke GD, Cranenburgh RM, Hanak JAJ, Ward JM. A modified Escherichia coli protein production strain expressing staphylococcal nuclease, capable of auto-hydrolysing host nucleic acid. J Biotechnology 2003; 101: 229-239.
93. Huisman, G.W., Luo, L.Z., Peoples, O.P.: US2004014197 (2004)
94. Boynton ZL, Koon JJ, Brennan EM, Clouart JD, Horowitx DM, Gerngross TU, Huisman GW. Reduction of cell lysate viscosity during processing of Poly (3-hydroxyalkanoates) by chromosomal integration of the Staphy-lococcal nuclease gene in Pseudomonas putida. Appl Environ Micro 1999; 65: 1524-1529.
95. Hodgson, C.P., Williams, J.A.: WO06026125 (2006).
96. Sayers JR, Eckstein F. Properties of overexpressed phage T5 D15 exonuclease. J Biol Chem 1990; 265: 18311-18317.
97. Sayers JR, Evans D, Thomson JB. Identification and eradication of a denatured DNA isolated during alkaline lysis-based plasmid purification procedures. Anal Biochem 1996; 241: 186-189.
98. Watson MP, Winters MA, Sagar SL, Konz JO. Sterilizing filtration of plasmid DNA: Effects of plasmid concentration, molecular weight, and conformation. Biotechnol Prog 2006; 22: 465-470.
99. Hyman, E.D.: WO05113808 (2005).
100. CBER draft guidance, Guidance for FDA Review Staff and Sponsors Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
101. Wolter T, Richter A. Assays for controlling host-cell impurities in biopharmaceuticals. Bioprocess International 2005; 2: 2-6.
102. Blanche, F., Couder, M., Maestrali, N., Guillemin, T., Gaillac, D.: WO05100542 (2005).
103. Wils, P., Ollivier, M.: US20046730781 (2004).
104. Nochumson, S., Durland, R., Yu-Speight, A., Welp, J., Wu, K., Hayes, R.: US2006106208 (2006).
105. Diogo MM, Querioz JA, Monteiro GA, Martins SAM, Ferreira GNM, Prazeres DMF. Purification of a cystic fibrosis plasmid vector for gene therapy using hydrophobic interaction chromatography. Biotechnol. Bioeng. 2000; 68: 576-583.
106. McNeilly, D.S.: US62001214586 (2001).
107. Lemmens, R., Olsson, U., Nyhammar, T., and Stadler, J. Supercoiled plasmid DNA: selective purification by thiophilic/aromatic adsorption. J. Chromatography B 2003; 784: 291-300.
108. Bussey, LB., Adamson, R., Atchley, A.: US20006011148 (2000).
109. Marquet, M., Horn., N., Meek, J., Budahzi, G.: US5561064 (1996).
110. Lander, RJ., Winters, M., Meacle, F.: WO0146215 (2001).
111. Crouzet, J., Scherman, D., Wils, P.: US20016287762 (2001).
112. Hanak, J.A.J., Williams, S.G.: US20046780632 (2004).
113. Cooke GD, Cranenburgh RM, Hanak JAJ, Dunnill P, Thatcher DR, Ward JM. Purification of essentially RNA free plasmid DNA using a modified Escherichia coli host strain expressing ribonuclease A. J. Biotechnology 2001; 85: 297-304.
114. Wahle, S., Schorr, J., Weber, M.: US20016242220 (2001).
115. Sancar A, Hack AM, Rupp WD. Simple method for identification of plasmid-encoded proteins. J Bacteriol 1979; 137: 692-693.
116. MacPhee, D.G., Radford, A.J., Reanney, D.C.: US4755464 (1988).
117. Hanak, J., Alexis, J., Ward, JM.: 2001.: WO0129209 (2001)
118. Willson III, R.C., Murphy, J.: US20036617108 (2003).
119. Murphy JC, Wibbenmeyer JA, Fox GE, Willson RC. Purification of plasmid DNA using selective precipitation by compaction agents. Nat Biotechnol 1999; 17: 822-23.
120. Mourich DV, Munks MW, Murphy JC, Willson RC, Hill AB. Spermine compaction is an efficient and economical method of producing vaccination-grade DNA. J Immunol Methods 2003; 274:257-64.
121. DeWalt BW, Murphy JC, Fox GE, Willson RC. Compaction agent clarification of microbial lysates. Protein Expr Purif 2003; 28:220-23.
122. Lander, R.J.; Winters, M.A.; Meacle, F.J.: US20046797476 (2004).
123. Lander RJ, Winters MA, Meacle FJ, Buckland BC, Lee AL. Fractional precipitation of plasmid DNA from lysate by CTAB. Biotechnol Bioeng 2002; 79:776-84.
124. Budahazi, G., Goff, B.: WO04060277 (2004).
125. Kostal J, Mulchandani A, Chen W. Affinity purification of plasmid DNA by temperature-triggered precipitation. Biotechnol Bioeng 2004; 85: 293-297.
126. Zhang JP, Wang Q, Smith TR, Hurst WE, Sulpizio T. Endotoxin removal using a synthetic adsorbent of crystalline calcium silicate hydrate. Biotechnol Prog 2005; 21:1220-25.
127. Wang Q, Zhang JP, Smith TR, Hurst WE, Sulpizio T. An electrokinetic study on a synthetic adsorbent of crystalline calcium silicate hydrate and its mechanism of endotoxin removal. Colloids Surf B Biointerfaces 2005; 44:110-16.
128. Winters MA, Richter JD, Sagar SL, Lee AL, Lander RJ. Plasmid DNA purification by selective calcium silicate adsorption of closely related impurities. Biotechnol Prog 2003; 19: 440-47.
129. Ghose S, Forde GM, Slater NKH. Affinity absorption of plasmid DNA. Biotechnol Prog 2004; 20: 841-850.
130. Hine, AV., Darby, RAJ.: WO06003355 (2006).
131. Kendall D, Lye GJ, Levy MS. Purification of plasmid DNA by an integrated operation comprising tangential flow filtration and nitrocellulose adsorption. Biotechnol Bioeng 2002; 79:816-22.
132. Eon-Duval A, MacDuff RH, Fisher CA, Harris MJ, Brook C. Removal of RNA impurities by tangential flow filtration in an RNase-free plasmid DNA purification process. Anal Biochem 2003; 316: 66-73.
133. Kahn DW, Butler MD, Cohen DL, Gordon M, Kahn JW, Winkler ME. Purification of plasmid DNA by tangential flow filtration. Biotechnol Bioeng 2000; 69:101-106.
134. Butler, M.D., Cohen, D.L., Kahn, D., Winkler, M.E.: WO0107599 (2001).
135. Varley DL, Hitchcock AG, Weiss AM, Horler WA, Cowell R, Peddie L, Sharpe GS, Thatcher DR, Hanak JA. Production of plasmid DNA for human gene therapy using modified alkaline cell lysis and expanded bed anion exchange chromatography. Bioseparation 1999; 8:209-17.
136. Ferreira GN, Cabral JM, Prazeres DM. Purification of supercoiled plasmid DNA using chromatographic processes. J Mol Recognit 1998; 11: 250-1.
137. Prazeres DM, Schluep T, Cooney C. Preparative purification of supercoiled plasmid DNA using anion-exchange chromatography. J Chromatogr A 1998; 806: 31-45.
138. Ferreira GN, Cabral JM, Prazeres DM. Anion exchange purification of plasmid DNA using expanded bed adsorption. Bioseparation 2000; 9:1-6.
139. Ferreira GN, Cabral JM, Prazeres DM. Studies on the batch adsorption of plasmid DNA onto anion-exchange chromatographic supports. Biotechnol Prog 2000; 16:416-24.
140. Eon-Duval A, Burke G. Purification of pharmaceutical-grade plasmid DNA by anion-exchange chromatography in an RNase-free process. J Chromatogr B Analyt Technol Biomed Life Sci 2004; 804:327-35.
141. Diogo MM, Queiroz JA, Prazeres DM. Chromatography of plasmid DNA. J Chromatogr A 2005; 1069:3-22.
142. Nochumson, S., Durland, R., Yu-Speight, A., Welp, J., Wu, K., Hayes, R.: US20067026468 (2006).
143. Horn, N., Budahazi, G., Marquet, M.: US5707812 (1998).
144. Murphy JC, Fox GE, Willson RC. Enhancement of anion-exchange chromatography of DNA using compaction agents. J Chromatogr A 2003; 984: 215-21.
145. Urthaler J, Schlegl R, Podgornik A, Strancar A, Jungbauer A, Necina R. Application of monoliths for plasmid DNA purification development and transfer to production. J Chromatogr A 2005; 1065:93-106.
146. Hanora A, Savina I, Plieva FM, Izumrudov VA, Mattiasson B, Galaev IY. Direct capture of plasmid DNA from non-clarified bacterial lysate using polycation-grafted monoliths. J Biotechnol 2006; 123:343-55.
147. Jungbauer A, Hahn R. Monoliths for fast bioseparation and bioconversion and their applications in biotechnology. J Sep Sci 2004; 27:767-78.
148. Bencina M, Podgornik A, Strancar A. Characterization of methacrylate monoliths for purification of DNA molecules. J Sep Sci 2004; 27:801-10.
149. Branovic K, Forcic D, Ivancic J, Strancar A, Barut M, Kosutic Gulija, T, Zgorelec R, Mazuran R. Application of short monolithic columns for fast purification of plasmid DNA. J Chromatogr B Analyt Technol Biomed Life Sci 2004; 801:331-7.
150. Strancar A, Podgornik A, Barut M, Necina R. Short monolithic columns as stationary phases for biochromatography. Adv Biochem Eng Biotechnol 2002; 76:49-85.
151. Necina, R., Urthaler, J., Strancar, A., Jancar, J., Merhar, M., Barut, M., Podgornik, A.: WO03051483 (2003).
152. Endres HN, Johnson JA, Ross CA, Welp JK, Etzel MR. Evaluation of an ion-exchange membrane for the purification of plasmid DNA. Biotechnol Appl Biochem 2003; 37:259-66.
153. Teeters MA, Root TW, Lightfoot EN. Adsorption and desorption behavior of plasmid DNA on ion-exchange membranes. Effect of salt valence and compaction agents. J Chromatogr A 2004;1036:73-8.
154. Teeters MA, Conrardy SE, Thomas BL, Root TW, Lightfoot EN. Adsorptive membrane chromatography for purification of plasmid DNA. J Chromatogr A 2003; 989: 165-73.
155. Teeters MA, Root TW, Lightfoot EN. Performance and scale-up of adsorptive membrane chromatography. J Chromatogr A 2002;944:129-39.
156. Haber C, Skupsky J, Lee A, Lander R. Membrane chromatography of DNA: conformation-induced capacity and selectivity. Biotechnol Bioeng 2004; 88:26-34.
157. Zhang S, Krivosheyeva A, Nochumson S. Large-scale capture and partial purification of plasmid DNA using anion-exchange membrane capsules. Biotechnol Appl Biochem 2003; 37:245-249.
158. Nochumson, S., Yang, Y., Kinsey, J.L.: WO0194573 (2001).
159. Trindade IP, Diogo MM, Prazeres DM, Marcos JC. Purification of plasmid DNA vectors by aqueous two-phase extraction and hydrophobic interaction chromatography. J Chromatogr A 2005; 1082:176-84.
160. Diogo, MM, Queiroz JA, Prazeres DM. Studies on the retention of plasmid DNA and Escherichia coli nucleic acids by hydrophobic interaction chromatography. Bioseparation 2001; 10:211-20.
161. Diogo MM, Ribeiro SC, Queiroz JA, Monteiro GA, Tordo N, Perrin P, Prazeres DM. Production, purification and analysis of an experimental DNA vaccine against rabies. J Gene Med 2001; 3:577-84.
162. Ramasubramanyan, N.: US20056953686 (2005).
163. Ramasubramanyan, N.: WO0073318 (2000).
164. de Franca Teixeira dos Prazeres, D.F., Fonseca Rodrigues Diogo, M.M., de Sampail Rodrigues Queiroz, J.: US20077169917 (2007).
165. de Franca Teixeira dos Prazeres, D.F., Fonseca Rodrigues Diogo, M.M., de Sampail Rodrigues Queiroz, J.: WO0204027 (2002).
166. Murphy JC, Jewell DL, White KI, Fox GE, Willson RC. Nucleic acid separations utilizing immobilized metal affinity chromatography. Biotechnol Prog 2003; 19: 982-986.
167. Willson, R.C., Murphy, J.C.: WO0246398 (2002).
168. Cano, T, Murphy JC, Fox GE, Willson RC. Separation of genomic DNA from plasmid DNA by selective renaturation with immobilized metal affinity capture. Biotech Prog 2005; 21: 1472-1477.
169. Albertsson, PA. Partition of double-stranded and single-stranded deoxyribonucleic acid. Arch Biochem Biophys Supplement 1962; 1:264-270.
170. Ribeiro SC, Monteiro GA, Cabral JMS, Prazeres DMF. Isolation of plasmid DNA from cell lysates by aqueous two-phase systems. Biotechnol Bioeng 2002; 78:376-84.
171. Ribeiro SC, Monteiro GA, Martinho G, Cabral JMS, Prazeres DMF. Quantitation of plasmid DNA in aqueous two-phase systems by fluourescence analysis. Biotechnol Lett 2000; 22:1101-1104.
172. Frerix A, Müller M, Kula MR, Hubbuch J. Scalable recovery of plasmid DNA based on aqueous two-phase separation. Biotechnol Appl Biochem 2005; 42:57-66.
173. Frerix A, Geilenkirchen P, Müller M, Kula MR, Hubbuch J. Separation of genomic DNA, RNA and open circular plasmid DNA from supercoiled plasmid DNA by combining denaturation, selective renaturation and aqueous two-phase extraction. Biotechnol Bioeng 2007; 96:57-66.
174. Frerix A, Schönewald M, Geilenkirchen P, Müller M, Kula MR, Hubbuch J. Exploitation of the coil-globule plasmid DNA transition induced by small changes in temperature, pH salt, and poly(ethylene glycol) compositions for directed partitioning in aqueous two-phase systems. Langmuir 2006; 22:4282-4290.
175. Kepka C, Rhodin J, Lemmens R, Tjerneld F, Gustavsson PE. Extraction of plasmid DNA from Escherichia coli cell lysate in a thermoseparating aqueous two-phase system. J Chromatogr A 2004; 1024:95-104.
176. Kepka C., Lemmens R, Vasi J, Nyhammar T, Gustavsson PE. Integrated process for purification of plasmid DNA using aqueous two-phase systems combined with membrane filtration and lid bead chromatography. J Chromatogr A 2004; 1057:115-24.
177. Kepka, C., Rhodin, J., Tjerneld, F.: WO04020629 (2000).
178. Müller, M., Hubbuch, J., Frerix, A., Kula, M.: US2006286080 (2006).
179. Lemmens, R., Nyhammar, T., Berglof, J., Stadler, J.: US20056916919 (2005).
180. PlasmidSelect Xtra for downstream processing of supercoiled plasmid DNA, Application Note 28: 4094-85. GE Healthcare.