Organic compounds -- part of the class 532-570 series – Organic compounds – Carbohydrates or derivatives
Reexamination Certificate
2007-01-30
2007-01-30
Ketter, James (Department: 1636)
Organic compounds -- part of the class 532-570 series
Organic compounds
Carbohydrates or derivatives
C210S635000
Reexamination Certificate
active
10332633
ABSTRACT:
The invention refers to a new process for the production of purification of high purity plasmid DNA. The process comprehends: a) the production of cells containing plasmid DNA, b) the disruption of the cells in order to obtain a lysate containing plasmid DNA, c) a concentration step by precipitation with isopropanol, d) a pre-purification and conditioning step by the addition of ammonium sulphate, e) a purification step using hydrophobic interaction chromatography, f) a final concentration and/or buffer exchange step. The process is scaleable, it does not use enzymes or mutagenic agents and it enables the preparation of plasmid DNA with pharmaceutical grade, which complies with the requirements of regulatory agencies. The invention belongs to the technical domain of Biochemical Engineering/Biotechnology.
REFERENCES:
patent: 5561064 (1996-10-01), Marquet et al.
patent: 5707812 (1998-01-01), Horn et al.
patent: 6503738 (2003-01-01), Thatcher et al.
patent: WO009851693 (1998-11-01), None
Diogo M M et al. “Purification of a cystic fibrosis plasmid vector for gene therapy using hydrophobic interaction chromatography.” Biotechnology and Bioengineering, vol. 68 No. 5, Jun. 5, 2000, pp. 576-583.
Diogo M M et al. “Separation and analysis of plasmid denatured forms using hydrophobic interation chromatography.” Analytical Biochemistry., vol. 275, No. 1, Nov. 1, 1999, pp. 122-124.
Birnboim et al., Nucleic Acids Research, vol. 7, No. 6, 1979;A Rapid Alkaline Extraction Procedure for Screening Recombinant Plasmid DNA1513-1523, © Information Retrieval Limited.
Ferreira et al., Centre for Biological and Chemical Engineering, Instituto Superior Tenico, Portugal;Monitoring of Process Streams in the Large-scale Production and Purification of Plasmid DNA for Gene Therapy Applications;© 1999 Pharm. Pharmacol. Commun., 5: 57-59.
Ferreira et al.; Centro de Engenhaira Biologica e Quimica, Instituto Superior Tecnico, Portugal;Development of Process Flow Sheets for the Purification of Supercoiled Plasmids for Gene Therapy Applications;Biotechnol. Prog. 1999, 15, 725-731.
Green et al.; BioPharm 1997;Preparative Purification of Supercoiled Plasmid DNA Therapeutic Applications;52-62.
Horn et al.; Mary Ann Liebert, Inc.;Cancer Gene Therapy Using Plasmid DNA: Purification of DNA for Human Clinical Trials;Human Gene Therapy 6:565-573 (May 1995).
Prazeres et al.; Elsevier Science B.V.;Preparative Purification of Supercoiled Plasmid DNA using Anion-exchange Chromatography;Journal of Chromatography A, 806, © 1998, 31-45.
Prazers et al.; TIBTECH Apr. 1999 (vol. 17);Large-scale Production of Pharmaceutical-grade Plasmid DNA for Gene Therapy: Problems and Bottlenecks;© 1888 Elsevier Science: 169-174.
Queiroz et al.; Elsevier Science B.V.;Hydrophobic Interaction Chromatography of Chromobacterium viscosum Lipase;Journal of Chromatography A, 707, © 1995, 137-142.
Queiroz et al.; Elsevier Science B.V.;Hydrophobic Interaction Chromatography of Chromobacterium viscosum Lipase on Polyethylene Glycol Immobilized on Sepharose;Journal of Chromatography A, 734, © 1996, 213-219.
Sambrook et al.; Laboratory Manual:Molecular Cloning;Cold Spring Harbor Laboratory Press; © 1989, front cover page, reverse front cover page, section:Extraction and Purification of Plasmid DNA:pp. 1.21-1.52; Reference pp. 1.105-1.110.
Schleef, Martin (reprint); Second, Completely Revised Edition © 1999;Biotechnology;vol. 5a: Recombinant Proteins, Monoclonal Antibodies and Therapeutic Genes; Wiley-VCH; front cover page, table of contents page; 20 Issues of Large-Scale Plasmid DNA Manufacturing; article front cover page, pp. 444-469.
Schluep et al.; Nucleic Acids Research;Purification of Plasmids by Triplex Affinity Interaction;© 1998 Oxford University Press; pp. 4524-4528.
Sundberg et al.; Journal of Chromatography, 90 (1974);Preparation of Adsorbents for Biospecific Affinity Chromatography;© Elsevier Scientific Publishing Company, pp. 87-98.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Mar. 1998;Guidance for Industry; Guidance for Human Somatic Cell Therapy and Gene Therapy; front cover page, table of contents pp. i and ii; pp. 1-27.
de Franca Teixeira dos Prazeres Duarte Miguel
De Sampaio Rodrigues Queiroz Joao Antonio
Fonseca Rodrigues Diogo Maria Margarida
Instituto Superior Tecnico
Ketter James
Merchant & Gould P.C.
Universidade da Beira Interior
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