Methods for purifying nucleic acids

Organic compounds -- part of the class 532-570 series – Organic compounds – Carbohydrates or derivatives

Reexamination Certificate

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C435S091100

Reexamination Certificate

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07807822

ABSTRACT:
Methods are provided for producing highly purified compositions of nucleic acids by using a highly streamlined and readily automated process. The methods use static mixers for lysing cells and precipitating debris, followed by centrifugation and ion exchange chromatography. The process may include a purification step using tangential flow ultrafiltration. A scaleable process for producing pharmaceutical grade plasmid DNA, useful for gene therapy, is provided.

REFERENCES:
patent: 3928642 (1975-12-01), Hubert et al.
patent: 4374063 (1983-02-01), Consolazio et al.
patent: 4450103 (1984-05-01), Konrad et al.
patent: 4462940 (1984-07-01), Hanisch et al.
patent: 4621061 (1986-11-01), Puhler et al.
patent: 4623723 (1986-11-01), Keller et al.
patent: 4780210 (1988-10-01), Hsia
patent: 4830969 (1989-05-01), Holmes
patent: 4900677 (1990-02-01), Hewitt
patent: 4985552 (1991-01-01), Fedeli
patent: 5008189 (1991-04-01), Oroskar et al.
patent: 5034314 (1991-07-01), Geiger et al.
patent: 5057426 (1991-10-01), Henco
patent: 5096818 (1992-03-01), DeBonville
patent: 5208160 (1993-05-01), Kikyotani et al.
patent: 5256294 (1993-10-01), Van Reis
patent: 5300433 (1994-04-01), Hrinda et al.
patent: 5561064 (1996-10-01), Marquet et al.
patent: 5707812 (1998-01-01), Horn et al.
patent: 5792651 (1998-08-01), Colpan et al.
patent: 5837529 (1998-11-01), Wan et al.
patent: 5981735 (1999-11-01), Thatcher et al.
patent: 5990301 (1999-11-01), Colpan et al.
patent: 6197553 (2001-03-01), Lee et al.
patent: 6214586 (2001-04-01), McNeilly
patent: 6297371 (2001-10-01), Colpan et al.
patent: 6503738 (2003-01-01), Thatcher et al.
patent: 6750333 (2004-06-01), Kuhne
patent: 2001/0034435 (2001-10-01), Nochumson
patent: 199721661 (1997-10-01), None
patent: 0 240 191 (1987-10-01), None
patent: 0 376 080 (1990-07-01), None
patent: 0 431 905 (1991-06-01), None
patent: 431905 (1991-06-01), None
patent: 0923592 (1998-02-01), None
patent: 0 814 156 (2003-03-01), None
patent: WO 87/07645 (1987-12-01), None
patent: WO 89/01035 (1989-02-01), None
patent: 517515 (1992-12-01), None
patent: WO 96/02658 (1996-02-01), None
patent: WO 96/21729 (1996-07-01), None
patent: WO 97/23601 (1997-07-01), None
patent: WO 98/01540 (1998-01-01), None
patent: WO 98/11208 (1998-03-01), None
patent: WO 98/30685 (1998-07-01), None
patent: WO 99/63076 (1999-12-01), None
Maniatis, T. Molecular Cloning. Cold Spring Harbor Laboratory. pp. 86-91, Jan. 1982.
Hubble et al. Alginate ultrafiltration membranes. Biotechnology Lett. vol. 7(4):273-276, Apr. 1985.
Rehnbothkar et al. Large scale preparation of bacteriophage lambda by tangential flow ultrafiltration for isolation of lambda DNA. Anal. Biochem. vol. 176:373-374, Jan. 1982.
Song et al. Theory of concentration polarization in crossflow filtration. J. Chem Faraday Trans. vol. 91(19):3389-3398, Oct. 1995.
Theodossiou et al., “The processing of a plasmid-based gene fromE. Coli.Primary recovery by filtration”,Bioprocess Engineering, 16:173-183 (1997).
Marquet et al., “Characterization of Plasmid DNA Vectors for Use in Human Gene Therapy, Part 1”,BioPharm, 42-50 (1997).
Papamichael et al., “Aqueous Phase Extraction of Proteins: Automated Processing and Recycling of Process Chemicals”,J. Chem. Tech. Biotechnol54:47-55 (1992).
Veide et al., “Continuous extraction of β-D-galactosidase fromEscherichia coliin an aqueous two-phase system: effects of biomass concentration on partitioning and mass transfer”,Enzyme Microb. Technol., 6:325-330 (1984).
Chandra, et al, “Large-scale purification of plasmid DNA by fast protein liquid chromatography using a hi-load Q sepharose column,”Analytical Biochemistry203:169-172 (1992).
Coppella, et al, “Isolation of high-molecular-weight nucleic acids for copy number analysis using high-performance liquid chromatography,”J. Chromatography402:189-199 (1987).
Davis, et al., “Short Technical Reports. Comparison of plasmid DNA preparation methods for direct gene transfer and genetic immunization,”BioTechniques21:92-99 (Jul. 1996).
Göbel, et al., “Quantitative electroelution of oligonucleotides and large DNA fragments from gels and purification by electrodialysis,”J. Biochemical and Biophysical Methods14:245-260 (1987).
Graf, et al., “Performance of a tubular microporous membrane filter used for in stu sampling of mammalian cell culture medium,”Biotechnology Techniques5(3):1-186 (1991).
Hom, et al, “Cancer gene therapy using plasmid DNA: Purification of DNA for human clinical trials,”Human Gene Therapy6:565-573 (May 1995).
Hou, et al., “Endotoxin removal by anion-exchange polymeric matrix,”Biotechnology and Applied Biochemistry12:315-324 (1990).
Marashi, et al, “Use of ultrafiltration microconcentrators in the concentration and desalting of DNA,”Bio Techniques, 3(3):238-240 (May/Jun. 1985).
Michaels, et al, “Tangential flow filtration,”Separations Technollogy, Pharmaceutical and Biotechnology Applications, Interpharm Press, Inc., Buffalo Grove, IL, Ch. 3, 57-193 (1995).
Montbriand, et al, Improved method for the removal of endotoxin from DNA,J. Biotechnology44:43-46 (1996).
Prazeres, et al., “Large-scale production of pharmaceutical-grade plasmid DNA for gene therapy: Problems and bottlenecks,”Tibtech, 17:169-174 (Apr. 1999).
Nils Olav Solum, “The Coagulogen of limulus polyphemus hemocytes. A comparison of the clotted and non-clotted forms of the molecule,”Thrombosis Research2:55-70 (1973).
Talmadge, et al, “Efficient endotoxin removal with a new sanitizable affinity column: Affi-prep polymyxin,”J. Chromatography476:175-185 (1989).
John A. Thompson, A review of high-performance liquid chromatography in nucleic acids research. III. Isolation, purification, and analysis of supercoiled plasmid DNA,BioChromatography1(2):68-80 (1986).
Vanhaecke, et al., “Endotoxin removal by end-line filters,”J Clinical Microbiology, 27(12):2710-2712 (Dec. 1989).
Weiss, et al., “Clearance of endotoxin from solution by adsorptive filtration with sartobind™ membrane adsorbers,”Sartorius Corporation, Developing Methods#7, Endotoxin Removal, p. 1-7 (1995).
Company brochure—Filtron, Membrane Separation Products, pp. 1-17 (1995-1996).
XP-00216258 “Plasmid Midi and Maxi Preparations” Diagen: The Qiagenologist/Application Protocols: 3rd Ed. Nov. 1990 p. 13-14.
Fractogel EMD Process Media. Merck KGaA.
Data Sheet TMAE (M) Properties of the tentacle ion-exchange sorbents.
Guide to tentacle-biochromatography products f/ http:www.chromatography.co.uk/products/bio/summary.
Supplemental European Search Report dated Nov. 2, 2002 in relatedEP1999932304.1.
Birnboim et al.; “A Rapid Alkaline Extraction Procedure for Screening recombinant plasmid DNA; ” Nucleic Acids Research; 7 (6) (1979) 1513-1523.
Blatt, et al.; “Solute Polarization and Cake Formation in Membrane Ultrafiltration: Causes, Consequences, and Control Techniques;” Membrane Science and Technology . . . proceeding sof a symposium . . . Columbus, Ohio (1969) 47-97.
Carlson, et al.; “Mechanical Disruption of Escherichia coli for Plasmid Recovery;” Biotechnology and Bioengineering, vol. 48, pp. 303-315 (1995).
Durland, et al.; “Manufacturing and Quality Control of Plasmid-Based Gene Expression Systems;” Advanced Drug Delivery Reviews 30 (1998) 33-48.
Fernandez, et al.; “Cross Flow Filtration of RNA Extracts by Hollow Fiber Membrane;” Acta Biotechnol. 12 (1992); pp. 49-56.
Gabler; “Principles of Tangential Flow Filtration: Applications to Biological Processing;” Filtration in the Pharmaceutical Industry; ISBN 08247751981 pp. 453-489.
Gutman; “The Technology of Pressure-Driven Crossflow Processes;” Adam Hilger, (1987)48-49, 192; ISBN 0-85274-52-2.
Hancher, et al.; “Evaluation of Ultrafiltration Membranes with Biological Macromolecules;” Biotechnol. Bioeng. 1973, 15(4), 67

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