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Volumn 30, Issue 1-3, 1998, Pages 33-48

Manufacturing and quality control of plasmid-based gene expression systems

Author keywords

DNA; DNA purification; Fermentation; Gene expression; Gene therapy; Manufacturing; Nucleic acid vaccines; Plasmid; Quality control

Indexed keywords

DISEASES; DNA; DRUG THERAPY; FERMENTATION; GENES; GENETIC ENGINEERING; MANUFACTURE; PATIENT TREATMENT; PROTEINS; PURIFICATION; QUALITY CONTROL;

EID: 0032473583     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0169-409X(97)00105-1     Document Type: Review
Times cited : (57)

References (61)
  • 1
    • 0030581323 scopus 로고    scopus 로고
    • Induction and characterization of humoral and cellular immune responses elicited via gene gun-mediated nucleic acid immunization
    • Haynes J.R., Fuller D.H., McCabe D., Swain W.F., Widers G. Induction and characterization of humoral and cellular immune responses elicited via gene gun-mediated nucleic acid immunization. Adv. Drug Del. Rev. 21:1996;3-18.
    • (1996) Adv. Drug Del. Rev. , vol.21 , pp. 3-18
    • Haynes, J.R.1    Fuller, D.H.2    McCabe, D.3    Swain, W.F.4    Widers, G.5
  • 2
    • 0030581320 scopus 로고    scopus 로고
    • Humoral and cellular immunities elicited by nucleic acid vaccines: Application to the human immunodeficiency virus and influenza
    • Shiver J.W., Ulmer J.B., Donnelly J.J., Liu M.A. Humoral and cellular immunities elicited by nucleic acid vaccines: application to the human immunodeficiency virus and influenza. Adv. Drug Del. Rev. 21:1996;19-31.
    • (1996) Adv. Drug Del. Rev. , vol.21 , pp. 19-31
    • Shiver, J.W.1    Ulmer, J.B.2    Donnelly, J.J.3    Liu, M.A.4
  • 3
    • 0030581324 scopus 로고    scopus 로고
    • DNA-based vaccination against Hepatitis B virus
    • Davis H.L. DNA-based vaccination against Hepatitis B virus. Adv. Drug Del. Rev. 21:1996;33-47.
    • (1996) Adv. Drug Del. Rev. , vol.21 , pp. 33-47
    • Davis, H.L.1
  • 6
    • 0029376858 scopus 로고
    • Gene therapy
    • Anderson W.F. Gene therapy. Sci. Am. 273:1995;124-128.
    • (1995) Sci. Am. , vol.273 , pp. 124-128
    • Anderson, W.F.1
  • 7
    • 0029147628 scopus 로고
    • Nonviral gene therapy: The promise of genes as pharmaceutical products
    • Ledley F.D. Nonviral gene therapy: the promise of genes as pharmaceutical products. Hum. Gene Ther. 6:1995;1129-1144.
    • (1995) Hum. Gene Ther. , vol.6 , pp. 1129-1144
    • Ledley, F.D.1
  • 10
    • 0029944718 scopus 로고    scopus 로고
    • Gene delivery systems for use in gene therapy: An overview of quality assurance and safety issues
    • Smith K.T., Shepard A.J., Boyd J.E., Lees G.M. Gene delivery systems for use in gene therapy: an overview of quality assurance and safety issues. Gene Ther. 3:1996;190-200.
    • (1996) Gene Ther. , vol.3 , pp. 190-200
    • Smith, K.T.1    Shepard, A.J.2    Boyd, J.E.3    Lees, G.M.4
  • 11
    • 0003194270 scopus 로고    scopus 로고
    • Controllable gene therapy using nonviral systems
    • P.L. Felgner, M.J. Heller, P. Lehn, J.P. Behr, F.C. Szoka, Jr. (Eds.) American Chemical Society, Washington D.C.
    • A. Rolland, E. Tomlinson, Controllable gene therapy using nonviral systems, in: P.L. Felgner, M.J. Heller, P. Lehn, J.P. Behr, F.C. Szoka, Jr. (Eds.), Artificial Self-Assembling Systems for Gene Delivery, American Chemical Society, Washington D.C., 1996, pp. 86-100.
    • (1996) Artificial Self-Assembling Systems for Gene Delivery , pp. 86-100
    • Rolland, A.1    Tomlinson, E.2
  • 12
    • 0001875768 scopus 로고
    • Process development for the manufacture of plasmid DNA vectors for use in gene therapy
    • Marquet M., Horn N.A., Meek J.A. Process development for the manufacture of plasmid DNA vectors for use in gene therapy. Biopharm. 8:1995;26-37.
    • (1995) Biopharm. , vol.8 , pp. 26-37
    • Marquet, M.1    Horn, N.A.2    Meek, J.A.3
  • 13
    • 0010623442 scopus 로고
    • Interim definition and elimination of lot-by-lot release for well-characterized therapeutic recombinant DNA-derived and monoclonal antibody biotechnology products
    • DoHHS, Interim definition and elimination of lot-by-lot release for well-characterized therapeutic recombinant DNA-derived and monoclonal antibody biotechnology products. Notice Fed. Reg. 60, 1995, 63048-63059.
    • (1995) Notice Fed. Reg. , vol.60 , pp. 63048-63059
  • 14
    • 0001184813 scopus 로고    scopus 로고
    • Elimination of establishment license application for specified biotechnology and specified synthetic biological products
    • DoHHS, Elimination of establishment license application for specified biotechnology and specified synthetic biological products. Notice Fed. Reg. 61, 1996, 24227-24233.
    • (1996) Notice Fed. Reg. , vol.61 , pp. 24227-24233
  • 15
    • 0029898210 scopus 로고    scopus 로고
    • Doing more with less at FDA
    • Wechsler J. Doing more with less at FDA. Biopharm. 9(10):1996;18-22.
    • (1996) Biopharm. , vol.9 , Issue.10 , pp. 18-22
    • Wechsler, J.1
  • 16
    • 0029988980 scopus 로고    scopus 로고
    • Keeping on track: Current quality control trends
    • Little L.E. Keeping on track: current quality control trends. Biopharm. 9(5):1996;72-77.
    • (1996) Biopharm. , vol.9 , Issue.5 , pp. 72-77
    • Little, L.E.1
  • 18
    • 0020442864 scopus 로고
    • The pUC plasmids, an M13mp7-derived system for insertion mutagenesis and sequencing with synthetic universal primers
    • Vieira J., Messing J. The pUC plasmids, an M13mp7-derived system for insertion mutagenesis and sequencing with synthetic universal primers. Gene. 19:1982;259-268.
    • (1982) Gene , vol.19 , pp. 259-268
    • Vieira, J.1    Messing, J.2
  • 20
    • 0021243339 scopus 로고
    • Mechanism of control of DNA replication and incompatibility in ColE1-type plasmids - A review
    • Davison J. Mechanism of control of DNA replication and incompatibility in ColE1-type plasmids - a review. Gene. 28:1984;1-15.
    • (1984) Gene , vol.28 , pp. 1-15
    • Davison, J.1
  • 21
    • 0019393944 scopus 로고
    • A perspective on the application of genetic engineering: Stability of recombinant plasmid
    • Imanaka T., Aiba S. A perspective on the application of genetic engineering: stability of recombinant plasmid. Ann. N.Y. Acad. Sci. 369:1981;1-14.
    • (1981) Ann. N.Y. Acad. Sci. , vol.369 , pp. 1-14
    • Imanaka, T.1    Aiba, S.2
  • 22
    • 0022407889 scopus 로고
    • Effects of recombinant plasmid content on growth properties and cloned gene product formation in Escherichia coli
    • Seo J.-H., Bailey J.E. Effects of recombinant plasmid content on growth properties and cloned gene product formation in Escherichia coli. Biotech. Bioeng. 27:1985;1668-1674.
    • (1985) Biotech. Bioeng. , vol.27 , pp. 1668-1674
    • Seo, J.-H.1    Bailey, J.E.2
  • 24
    • 0021679310 scopus 로고
    • Temperature-dependent retention of a tryptophan-operon-bearing plasmid in Escherichia coli
    • Skogman S.G., Nilsson J. Temperature-dependent retention of a tryptophan-operon-bearing plasmid in Escherichia coli. Gene. 31:1984;117-122.
    • (1984) Gene , vol.31 , pp. 117-122
    • Skogman, S.G.1    Nilsson, J.2
  • 25
    • 0025055526 scopus 로고
    • Use of the Escherichia coli ssb gene to prevent bioreactor takeover by plasmidless cells
    • Porter R.D., Black S., Pannuri S., Carlson A. Use of the Escherichia coli ssb gene to prevent bioreactor takeover by plasmidless cells. Bio/Technol. 8:1990;47-51.
    • (1990) Bio/Technol. , vol.8 , pp. 47-51
    • Porter, R.D.1    Black, S.2    Pannuri, S.3    Carlson, A.4
  • 27
    • 0024024835 scopus 로고
    • DNA supercoiling and the anaerobic and growth phase regulation of tonB gene expression
    • Dorman C.J., Barr G.C., Bhriain N.N., Higgins C.F. DNA supercoiling and the anaerobic and growth phase regulation of tonB gene expression. J. Bacteriol. 170:1988;2816-2826.
    • (1988) J. Bacteriol. , vol.170 , pp. 2816-2826
    • Dorman, C.J.1    Barr, G.C.2    Bhriain, N.N.3    Higgins, C.F.4
  • 28
    • 0004738888 scopus 로고
    • Regulation of bacterial DNA supercoiling: Plasmid linking numbers vary with growth temperature
    • Goldstein E., Drlica K. Regulation of bacterial DNA supercoiling: plasmid linking numbers vary with growth temperature. Proc. Natl. Acad. Sci. USA. 81:1984;4046-4050.
    • (1984) Proc. Natl. Acad. Sci. USA , vol.81 , pp. 4046-4050
    • Goldstein, E.1    Drlica, K.2
  • 29
    • 0028978028 scopus 로고
    • Cancer gene therapy using plasmid DNA: Purification of DNA for human clinical trials
    • Horn N.A., Meek J.A., Budahazi G., Marquet M. Cancer gene therapy using plasmid DNA: purification of DNA for human clinical trials. Hum. Gene Ther. 6:1995;565-573.
    • (1995) Hum. Gene Ther. , vol.6 , pp. 565-573
    • Horn, N.A.1    Meek, J.A.2    Budahazi, G.3    Marquet, M.4
  • 31
    • 0029796205 scopus 로고    scopus 로고
    • High-yield production of pBR322-derived plasmids intended for human gene therapy by employing a temperature-controllable point mutation
    • Lahijani R., Hulley G., Soriano G., Horn N.A., Marquet M. High-yield production of pBR322-derived plasmids intended for human gene therapy by employing a temperature-controllable point mutation. Hum. Gene Ther. 7:1996;1971-1980.
    • (1996) Hum. Gene Ther. , vol.7 , pp. 1971-1980
    • Lahijani, R.1    Hulley, G.2    Soriano, G.3    Horn, N.A.4    Marquet, M.5
  • 32
    • 0018800089 scopus 로고
    • A rapid alkaline extraction procedure for screening recombinant plasmid DNA
    • Birnboim H.C., Doly J. A rapid alkaline extraction procedure for screening recombinant plasmid DNA. Nucleic Acids Res. 7:1979;1513-1523.
    • (1979) Nucleic Acids Res. , vol.7 , pp. 1513-1523
    • Birnboim, H.C.1    Doly, J.2
  • 33
    • 0028991824 scopus 로고
    • Bacterial lipopolysaccharide copurifies with plasmid DNA: Implications for animal models and human gene therapy
    • Wicks I.P., Howell M.L., Hancock T., Kohsaka H., Olee T., Carson D.A. Bacterial lipopolysaccharide copurifies with plasmid DNA: implications for animal models and human gene therapy. Hum. Gene Ther. 6:1995;317-323.
    • (1995) Hum. Gene Ther. , vol.6 , pp. 317-323
    • Wicks, I.P.1    Howell, M.L.2    Hancock, T.3    Kohsaka, H.4    Olee, T.5    Carson, D.A.6
  • 34
    • 8944250223 scopus 로고    scopus 로고
    • Comparison of plasmid DNA preparation methods for direct gene transfer and genetic immunization
    • Davis H.L., Schleef M., Moritz P., Mancini M., Schorr J., Whalen R.G. Comparison of plasmid DNA preparation methods for direct gene transfer and genetic immunization. Biotechniques. 21:1996;92-99.
    • (1996) Biotechniques , vol.21 , pp. 92-99
    • Davis, H.L.1    Schleef, M.2    Moritz, P.3    Mancini, M.4    Schorr, J.5    Whalen, R.G.6
  • 35
    • 0002396941 scopus 로고
    • A review of high-performance liquid chromatography in nucleic acids research. III. Isolation, purification, and analysis of supercoiled plasmid DNA
    • Thompson J.A. A review of high-performance liquid chromatography in nucleic acids research. III. Isolation, purification, and analysis of supercoiled plasmid DNA. Biochrom. 1:1986;68-80.
    • (1986) Biochrom. , vol.1 , pp. 68-80
    • Thompson, J.A.1
  • 36
    • 0026666888 scopus 로고
    • Large-scale purification of plasmid DNA by fast protein liquid chromatography using a Hi-Load Q Sepharose column
    • Chandra G., Patel P., Kost T.A., Gray J.G. Large-scale purification of plasmid DNA by fast protein liquid chromatography using a Hi-Load Q Sepharose column. Anal. Biochem. 203:1992;169-172.
    • (1992) Anal. Biochem. , vol.203 , pp. 169-172
    • Chandra, G.1    Patel, P.2    Kost, T.A.3    Gray, J.G.4
  • 37
    • 0026598470 scopus 로고
    • Large- scale purification of plasmid DNA by anion-exchange high-performance liquid chromatography
    • Hines R.H., O'Connor K.C., Vella G., Warren W. Large- scale purification of plasmid DNA by anion-exchange high-performance liquid chromatography. Biotechniques. 12:1992;430-434.
    • (1992) Biotechniques , vol.12 , pp. 430-434
    • Hines, R.H.1    O'Connor, K.C.2    Vella, G.3    Warren, W.4
  • 38
    • 0027292525 scopus 로고
    • Size-dependent chromatographic separation of nucleic acids
    • Kasai K. Size-dependent chromatographic separation of nucleic acids. J. Chrom. 618:1993;203-221.
    • (1993) J. Chrom. , vol.618 , pp. 203-221
    • Kasai, K.1
  • 39
    • 0022016460 scopus 로고
    • Rapid large-scale purification of plasmid DNA by medium or low pressure gel filtration. Application: Construction of thermoamplifiable expression vectors
    • Vo-Quang T., Malpiece Y., Buffard D., Kaminski P.A., Vidal D., Strosberg A.D. Rapid large-scale purification of plasmid DNA by medium or low pressure gel filtration. Application: construction of thermoamplifiable expression vectors. Biosci. Rep. 5:1985;101-111.
    • (1985) Biosci. Rep. , vol.5 , pp. 101-111
    • Vo-Quang, T.1    Malpiece, Y.2    Buffard, D.3    Kaminski, P.A.4    Vidal, D.5    Strosberg, A.D.6
  • 40
    • 0019780417 scopus 로고
    • Purification of supercoiled DNA of plasmid Col E1 by RPC-5 chromatography
    • Best A.N., Allison D.P., Novelli G.D. Purification of supercoiled DNA of plasmid Col E1 by RPC-5 chromatography. Anal. Biochem. 114:1981;235-243.
    • (1981) Anal. Biochem. , vol.114 , pp. 235-243
    • Best, A.N.1    Allison, D.P.2    Novelli, G.D.3
  • 42
    • 0026479071 scopus 로고
    • Preparation of DNA topoisomers by RP-18 high-performance liquid chromatography
    • Kapp U., Langowski J. Preparation of DNA topoisomers by RP-18 high-performance liquid chromatography. Anal. Biochem. 206:1992;293-299.
    • (1992) Anal. Biochem. , vol.206 , pp. 293-299
    • Kapp, U.1    Langowski, J.2
  • 43
    • 0018259328 scopus 로고
    • Rapid purification of plasmid DNAs by hydroxyapatite chromatography
    • Colman A., Byers M.J., Primrose S.B., Lyons A. Rapid purification of plasmid DNAs by hydroxyapatite chromatography. Eur. J. Biochem. 91:1978;303-310.
    • (1978) Eur. J. Biochem. , vol.91 , pp. 303-310
    • Colman, A.1    Byers, M.J.2    Primrose, S.B.3    Lyons, A.4
  • 44
    • 0017878971 scopus 로고
    • A rapid method for the isolation of circular DNA using an aqueous two-phase partition system
    • Ohlsson R., Hentschel C.C., Williams J.G. A rapid method for the isolation of circular DNA using an aqueous two-phase partition system. Nucleic Acids Res. 5:1978;583-590.
    • (1978) Nucleic Acids Res. , vol.5 , pp. 583-590
    • Ohlsson, R.1    Hentschel, C.C.2    Williams, J.G.3
  • 45
    • 0027535053 scopus 로고
    • Plasmid rescue from transgenic mouse DNA using LacI repressor protein conjugated to magnetic beads
    • Gossen J.A., de Leeuw W.J.F., Molijn A.C., Vijg J. Plasmid rescue from transgenic mouse DNA using LacI repressor protein conjugated to magnetic beads. Biotechniques. 14:1993;624-629.
    • (1993) Biotechniques , vol.14 , pp. 624-629
    • Gossen, J.A.1    De Leeuw, W.J.F.2    Molijn, A.C.3    Vijg, J.4
  • 46
    • 0026543372 scopus 로고
    • Sequence-specific DNA purification by triplex affinity capture
    • Ito T., Smith C.L., Cantor C.R. Sequence-specific DNA purification by triplex affinity capture. Proc. Natl. Acad. Sci. USA. 89:1992;495-498.
    • (1992) Proc. Natl. Acad. Sci. USA , vol.89 , pp. 495-498
    • Ito, T.1    Smith, C.L.2    Cantor, C.R.3
  • 47
    • 0027917443 scopus 로고
    • Rapid purification of double-stranded DNA by triple-helix-mediated affinity capture
    • Ji H., Smith L.M. Rapid purification of double-stranded DNA by triple-helix-mediated affinity capture. Anal. Chem. 65:1993;1323-1328.
    • (1993) Anal. Chem. , vol.65 , pp. 1323-1328
    • Ji, H.1    Smith, L.M.2
  • 52
    • 0029939446 scopus 로고    scopus 로고
    • Establishing cell banks under current good manufacturing practices
    • Steuer A., Ostrove J.M. Establishing cell banks under current good manufacturing practices. Biopharm. 9(6):1996;40-44.
    • (1996) Biopharm. , vol.9 , Issue.6 , pp. 40-44
    • Steuer, A.1    Ostrove, J.M.2
  • 54
    • 0027973765 scopus 로고
    • Regulatory considerations for nucleic acid vaccines
    • Smith H.A. Regulatory considerations for nucleic acid vaccines. Vaccine. 12:1994;1515-1519.
    • (1994) Vaccine , vol.12 , pp. 1515-1519
    • Smith, H.A.1
  • 56
    • 0029729895 scopus 로고    scopus 로고
    • Qualification of raw materials for clinical biopharmaceutical manufacturing
    • Del Tito B.J. Jr., Trembley M.A., Shadle P.J. Qualification of raw materials for clinical biopharmaceutical manufacturing. Biopharm. 9(10):1996;45-49.
    • (1996) Biopharm. , vol.9 , Issue.10 , pp. 45-49
    • Del Tito B.J., Jr.1    Trembley, M.A.2    Shadle, P.J.3
  • 58
    • 0023041422 scopus 로고
    • Expression of transfected DNA depends on DNA topology
    • Weintraub H., Cheng P.F., Conrad K. Expression of transfected DNA depends on DNA topology. Cell. 46:1986;115-122.
    • (1986) Cell , vol.46 , pp. 115-122
    • Weintraub, H.1    Cheng, P.F.2    Conrad, K.3
  • 60
    • 0027223719 scopus 로고
    • Activity of a microinjected inducible murine hsp68 gene promoter depends on plasmid configuration and the presence of heat shock elements in mouse dictyate oocytes but not in two-cell embryos
    • Bevilacqua A., Mangia F. Activity of a microinjected inducible murine hsp68 gene promoter depends on plasmid configuration and the presence of heat shock elements in mouse dictyate oocytes but not in two-cell embryos. Devel. Genet. 14:1993;92-102.
    • (1993) Devel. Genet. , vol.14 , pp. 92-102
    • Bevilacqua, A.1    Mangia, F.2


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