메뉴 건너뛰기




Volumn , Issue , 2011, Pages 453-482

Validation of downstream processes

Author keywords

[No Author keywords available]

Indexed keywords


EID: 85064616991     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter
Times cited : (4)

References (66)
  • 1
    • 85064694444 scopus 로고
    • Ad Hoc Working Party on Biotechnology/Pharmacy, Commission of the European Communities, Biotech headings for Notice to Applicants, Part II
    • Ad Hoc Working Party on Biotechnology/Pharmacy, Commission of the European Communities, Biotech headings for Notice to Applicants, Part II, 1992
    • (1992)
  • 3
    • 85064653741 scopus 로고
    • Requirements and Validation of a Biotech Multipurpose Plant
    • Allgaier, H. (1994) Requirements and Validation of a Biotech Multipurpose Plant. Chimia 48, 464-466
    • (1994) Chimia , vol.48 , pp. 464-466
    • Allgaier, H.1
  • 4
    • 85064693021 scopus 로고    scopus 로고
    • Conversion of a Biotech Facility to "Multi-Use" Operation
    • (Barnacal, P.A., ed.), Sterling Publications Limited, London W2 1XR
    • Allgaier, H. (1996) Conversion of a Biotech Facility to "Multi-Use" Operation. In: Pharmaceutical Biotechnology Internationl (Barnacal, P.A., ed.), Sterling Publications Limited, London W2 1XR, pp 47-48
    • (1996) Pharmaceutical Biotechnology Internationl , pp. 47-48
    • Allgaier, H.1
  • 5
    • 85064606786 scopus 로고
    • Impurities, and Contaminants in Biological Drug Products, Philadelphia
    • American Society for Testing and Materials (ASTU) (1988) Draft Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products, Philadelphia
    • (1988) Draft Standard Guide for Determination of Purity
  • 9
    • 0027016748 scopus 로고
    • Experimental approaches to guarantee minimal risk of potential virus in purified monoclonal antibodies
    • Berthold, W., Walter, J. and Werz, W. (1992) Experimental approaches to guarantee minimal risk of potential virus in purified monoclonal antibodies, Cytotechnology 9, 189-201
    • (1992) Cytotechnology , vol.9 , pp. 189-201
    • Berthold, W.1    Walter, J.2    Werz, W.3
  • 10
    • 0029176708 scopus 로고
    • Optimization of Protein G Chromatography for Biopharmaceutical Monoclonal Antibodies
    • Bill, E., Lutz, U., Sparrmann, M., and Allgaier, H. (1995) Optimization of Protein G Chromatography for Biopharmaceutical Monoclonal Antibodies. Journal of Molecular Recognition 8, 90-94
    • (1995) Journal of Molecular Recognition , vol.8 , pp. 90-94
    • Bill, E.1    Lutz, U.2    Sparrmann, M.3    Allgaier, H.4
  • 11
    • 0021271484 scopus 로고
    • Tumorigenic activity of Polyoma virus and SV40 DNAs in newborn rodents
    • Bouchard, L., Geiinas, C., Asselin, C. and Bastin, M. (1984) Tumorigenic activity of Polyoma virus and SV40 DNAs in newborn rodents. Virology 135, 53-64
    • (1984) Virology , vol.135 , pp. 53-64
    • Bouchard, L.1    Geiinas, C.2    Asselin, C.3    Bastin, M.4
  • 12
    • 0002261647 scopus 로고
    • Purification of Monoclonal Antibodies for Human Clinical Use: Validation of DNA and Retroviral Clearance
    • SCI, Elsevier Applied Science, London-New York
    • Brady, D., Bonnerjea, J. and Hill, C.R. (1990) Purification of Monoclonal Antibodies for Human Clinical Use: Validation of DNA and Retroviral Clearance. In: Separations For Biotechnology 2, SCI, Elsevier Applied Science, London-New York
    • (1990) Separations For Biotechnology 2
    • Brady, D.1    Bonnerjea, J.2    Hill, C.R.3
  • 15
    • 85064683012 scopus 로고    scopus 로고
    • Committee for proprietary medicinal products (July 1987) Notes to applicants for marketing authorization on requirements for production and quality control of medicinal products derived by recombinant DNA technology
    • Committee for proprietary medicinal products (July 1987) Notes to applicants for marketing authorization on requirements for production and quality control of medicinal products derived by recombinant DNA technology
  • 16
    • 85064675870 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products Ad Hoc Working Party on Biotechnology/ Pharmacy (June 1987) Guidelines on the Production and quality control of monoclonal antibodies of murine origin intended for use in man
    • Committee for Proprietary Medicinal Products Ad Hoc Working Party on Biotechnology/ Pharmacy (June 1987) Guidelines on the Production and quality control of monoclonal antibodies of murine origin intended for use in man
  • 17
    • 85064704355 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products Ad Hoc Working Party on Biotechnology/ Pharmacy (July 1990) Guidelines on the production and quality control of human monoclonal antibodies
    • Committee for Proprietary Medicinal Products Ad Hoc Working Party on Biotechnology/ Pharmacy (July 1990) Guidelines on the production and quality control of human monoclonal antibodies
  • 18
    • 85064680390 scopus 로고
    • Council of Europe European Pharmacopeia
    • Council of Europe (1990) European Pharmacopeia
    • (1990)
  • 19
    • 85064669280 scopus 로고
    • Guidelines on General Principles of Process Validation
    • Division of Manufacturing and Product Quality, FDA (1987) Guidelines on General Principles of Process Validation
    • (1987)
  • 20
    • 85064636269 scopus 로고
    • Guidelines on Sterile Drug Product Produced by Aseptic Processing
    • Division of Manufacturing and Product Quality, FDA (1987) Guidelines on Sterile Drug Product Produced by Aseptic Processing
    • (1987)
  • 23
    • 85064710307 scopus 로고
    • Points to Consider in the Characterization of Cell Lines to Produce Biological Products
    • FDA, Center for Biologies Evaluation and Research, Bethesda, MD, USA (1987) Points to Consider in the Characterization of Cell Lines to Produce Biological Products
    • (1987)
  • 24
    • 85064631281 scopus 로고
    • Points to Consider in the Manufacture of Monoclonal Antibody Products for Human Use
    • FDA, Center for Biologies Evaluation and Research, Bethesda, MD, USA (1987) Points to Consider in the Manufacture of Monoclonal Antibody Products for Human Use
    • (1987)
  • 26
    • 85064703617 scopus 로고
    • Points to Consider in Human Somatic Cell Therapy and Gene Therapy
    • FDA, Center for Biologies Evaluation and Research, Bethesda, MD, USA (1991) Points to Consider in Human Somatic Cell Therapy and Gene Therapy
    • (1991)
  • 27
    • 85064673905 scopus 로고
    • Antiviral Drugs for Non-Life-Threatening Disease: Draft Points to Consider for Safety Evaluation Prior to Phase 1 Studies
    • FDA, Center for Drugs and Biologies, Bethesda, MD, USA (1985) Antiviral Drugs for Non-Life-Threatening Disease: Draft Points to Consider for Safety Evaluation Prior to Phase 1 Studies
    • (1985)
  • 28
    • 0003548166 scopus 로고
    • FDA, Office of Biologies Research and Review, Center for Drugs and Biologies, Bethesda, MD, USA (April 10 1985) Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology
    • FDA, Office of Biologies Research and Review, 8800 Rockville Rike, Bethesda MD, 20892 USA (1987) Points to consider in the characterization of cell lines used to produce Biologicals. FDA, Office of Biologies Research and Review, Center for Drugs and Biologies, Bethesda, MD, USA (April 10,1985) Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology
    • (1987) Points to consider in the characterization of cell lines used to produce Biologicals
  • 29
    • 85064707883 scopus 로고
    • Interferon Test Procedures: Points to Be Considered in the Production and Testing of Interferon Intended for Investigational Use in Humans
    • FDA, Office of Biologies, Bethesda, MD, USA (1983) Interferon Test Procedures: Points to Be Considered in the Production and Testing of Interferon Intended for Investigational Use in Humans
    • (1983)
  • 30
    • 0024270948 scopus 로고
    • The Role of Quality Control in Biotechnology: An Analytical Perspective
    • Garnick, R.L., Solli, N.J. and Papa, P.A. (1988) The Role of Quality Control in Biotechnology: An Analytical Perspective. Anal. Chem. 60, 2546-2557
    • (1988) Anal. Chem , vol.60 , pp. 2546-2557
    • Garnick, R.L.1    Solli, N.J.2    Papa, P.A.3
  • 31
    • 85064637894 scopus 로고
    • Manufacture and Testing of Biologies Produced by Recombinant DNA Technology
    • Health and Welfare Canada (1990) Drugs Directorate Guidelines, Manufacture and Testing of Biologies Produced by Recombinant DNA Technology
    • (1990) Drugs Directorate Guidelines
  • 32
    • 85064637894 scopus 로고
    • Utilization of Continuous Cell Lines in the Manufacture of Biologies
    • Health and Welfare Canada (1990) Drugs Directorate Guidelines, Utilization of Continuous Cell Lines in the Manufacture of Biologies
    • (1990) Drugs Directorate Guidelines
  • 34
    • 0024562175 scopus 로고
    • Investigations into the application of tri(n-butyl) phosphate/detergent mixtures to blood derivatives. Virus inactivation in plasma products
    • (Mortenthaler, J.-J., ed.), Karger, Basel
    • Horowitz, B. (1989) Investigations into the application of tri(n-butyl) phosphate/detergent mixtures to blood derivatives. Virus inactivation in plasma products. Curr. Stud. Hematol. Blood Transfus., No. 56 (Mortenthaler, J.-J., ed.), pp 83-96, Karger, Basel
    • (1989) Curr. Stud. Hematol. Blood Transfus., No. 56 , pp. 83-96
    • Horowitz, B.1
  • 35
    • 85064654987 scopus 로고
    • Workshop on Preclinical Safety Testing of Monoclonal, Antibodies, Bethesda, MD, USA
    • Kozak, R. (1992) Current FDA Requirements for Phase 1 Studies, Workshop on Preclinical Safety Testing of Monoclonal, Antibodies, Bethesda, MD, USA
    • (1992) Current FDA Requirements for Phase 1 Studies
    • Kozak, R.1
  • 37
    • 85027648924 scopus 로고
    • Validation of Downstream Processes
    • Quality Biotech, Glasgow
    • Lees, G. and Onions, D. (1990) Validation of Downstream Processes. Technical Bulletin 4, Quality Biotech, Glasgow
    • (1990) Technical Bulletin , vol.4
    • Lees, G.1    Onions, D.2
  • 38
    • 0009859175 scopus 로고
    • Detection of Viruses in Recombinant Cells by Electron Microscopy
    • (Spier, R.E., Griffiths, J.B. and MacDonald, C., eds.), Butterworth-Heinemann Ltd. Linacre House, Jordan Hill, Oxford 0X2 8DP
    • Liptrot, C. and Gull, K. (1991) Detection of Viruses in Recombinant Cells by Electron Microscopy. In: Animal Cell Technology: Developments, Processes and Products (Spier, R.E., Griffiths, J.B. and MacDonald, C., eds.), Butterworth-Heinemann Ltd. Linacre House, Jordan Hill, Oxford 0X2 8DP, pp 653-656
    • (1991) Animal Cell Technology: Developments, Processes and Products , pp. 653-656
    • Liptrot, C.1    Gull, K.2
  • 39
    • 0025302510 scopus 로고
    • Risk of Tumor Induction In Vivo by Residual Cellular DNA: Quantitative Considerations
    • Löwer, J. (1990) Risk of Tumor Induction In Vivo by Residual Cellular DNA: Quantitative Considerations. J. Med. Virol. 31, 50-53
    • (1990) J. Med. Virol , vol.31 , pp. 50-53
    • Löwer, J.1
  • 40
    • 0026289471 scopus 로고
    • Virological Aspects of the Quality Control of Biologicals: Quantitative Considerations
    • England, 1990. Develop, biol. Standard, S. Karger, Basel
    • Löwer, J. (1991) Virological Aspects of the Quality Control of Biologicals: Quantitative Considerations. In: Symposium on Virological Aspects of the Safety of Biological Products London, England, 1990. Develop, biol. Standard. 75, pp 221-226, S. Karger, Basel
    • (1991) Symposium on Virological Aspects of the Safety of Biological Products London , vol.75 , pp. 221-226
    • Löwer, J.1
  • 42
    • 85064656079 scopus 로고
    • Documents necessary for application for approval of drugs manufactured using cell culture technology
    • Ministry of Health and Welfare, Japan (1988) Documents necessary for application for approval of drugs manufactured using cell culture technology
    • (1988)
  • 43
    • 0021111063 scopus 로고
    • Characteristics of Immobilized Histamin for Pyrogen Adsorption
    • Minobe, S., Tadashi, S., Tetsuya, T. and Chibata, J. (1983) Characteristics of Immobilized Histamin for Pyrogen Adsorption. J. Chromatogr. 262, 193-198
    • (1983) J. Chromatogr , vol.262 , pp. 193-198
    • Minobe, S.1    Tadashi, S.2    Tetsuya, T.3    Chibata, J.4
  • 44
    • 85064644557 scopus 로고
    • "Threshold Total DNA Assay"
    • (May 7 1986) Guidelines for Research Involving Recombinant DNA Molecules. Department of Helth and Human Services
    • Molecular Devices Corporation, publication 0120-0501A (1988) "Threshold Total DNA Assay". National Institutes of Health (May 7, 1986) Guidelines for Research Involving Recombinant DNA Molecules. Department of Helth and Human Services
    • (1988) National Institutes of Health
  • 46
    • 79955629892 scopus 로고
    • Inactivation of Endotoxin by Polymyxin B
    • Parenteral Drug Association, Inc., Philadelphia
    • Novitsky, T.J. and Gould, M.J. (1985) Inactivation of Endotoxin by Polymyxin B. in: Technical Report No. 7, Parenteral Drug Association, Inc., Philadelphia
    • (1985) Technical Report No 7
    • Novitsky, T.J.1    Gould, M.J.2
  • 47
    • 85064639092 scopus 로고    scopus 로고
    • (June 26, 1986) 23301-23750, Coordinated Framework for Regulation of Biotechnology
    • Office of Science and Technology Policy, Federal Register, Vol. 51, No. 123 (June 26, 1986) 23301-23750, Coordinated Framework for Regulation of Biotechnology
    • , vol.51 , Issue.123
  • 48
    • 85064700551 scopus 로고    scopus 로고
    • (July 16, 1986) Recombinant DNA Safety Considerations
    • Organization for Economic Cooperation and Development (OECD) (July 16, 1986) Recombinant DNA Safety Considerations
  • 49
    • 85027631714 scopus 로고
    • Molecular Hybridization Techniques and Polymerase Chain Reaction (PCR) as Methods for Safety Assessment of Animal Cells used in Biopharmaceutical Production
    • (Spier, R. E., Griffiths, J. B. and MacDonald, C., eds.), Butterworth-Heinemann Ltd. Linacre House, Jordan Hill, Oxford OX2 8DP
    • Ostrove, J.M., Walsh, W., Vacante, D. and Patel, N. (1992) Molecular Hybridization Techniques and Polymerase Chain Reaction (PCR) as Methods for Safety Assessment of Animal Cells used in Biopharmaceutical Production. In: Animal Cell Technology: Developments, Processes and Products (Spier, R. E., Griffiths, J. B. and MacDonald, C., eds.), Butterworth-Heinemann Ltd. Linacre House, Jordan Hill, Oxford OX2 8DP, pp 689-695
    • (1992) Animal Cell Technology: Developments, Processes and Products , pp. 689-695
    • Ostrove, J.M.1    Walsh, W.2    Vacante, D.3    Patel, N.4
  • 50
    • 12644279851 scopus 로고
    • Parenteral Drug Association, Inc., Philadelphia (1985) Depyrogenation, Technical Report No. 7
    • (1985) Depyrogenation
  • 51
    • 0002668647 scopus 로고
    • Advances in Parenteral Sciences/2, Marcel Dekker, Inc., New York, Basel
    • Pearson III, F. C. (1985) Pyrogens. Advances in Parenteral Sciences/2, Marcel Dekker, Inc., New York, Basel
    • (1985) Pyrogens
    • Pearson, F.C.1
  • 52
    • 85027662509 scopus 로고
    • Pyrogens and Depyrogenation, Theory and Practice
    • (Olson, W.P. and Groves, M.J., eds.), Interpharm Press Inc., Prairie View
    • Pearson III, F. C. (1987) Pyrogens and Depyrogenation, Theory and Practice. In: Aseptic Pharmaceutical Manufacturing (Olson, W.P. and Groves, M.J., eds.), Interpharm Press Inc., Prairie View
    • (1987) Aseptic Pharmaceutical Manufacturing
    • Pearson, F.C.1
  • 53
    • 0024730245 scopus 로고
    • Quantification of Residual DNA in Biological Products
    • Per, S.R., Aversa, C.R. and Sito, A.F. (1989) Quantification of Residual DNA in Biological Products. Clinical Chemistry 35, 1859-1860
    • (1989) Clinical Chemistry , vol.35 , pp. 1859-1860
    • Per, S.R.1    Aversa, C.R.2    Sito, A.F.3
  • 54
    • 0020688781 scopus 로고
    • b-Propiolactone/Ultraviolett Irradiation: A Review of Its Effectiveness for Inactivation of Viruses in Blood Derivatives
    • Prince, A.M., Stephan, W. and Brotmann, B. (1993) b-Propiolactone/Ultraviolett Irradiation: A Review of Its Effectiveness for Inactivation of Viruses in Blood Derivatives. Rev. Infect. Dis. 5, 92-107
    • (1993) Rev. Infect. Dis , vol.5 , pp. 92-107
    • Prince, A.M.1    Stephan, W.2    Brotmann, B.3
  • 55
    • 0017375464 scopus 로고
    • Labeling deroxyribonucleic acid to high specific activity in vitro by nick translation with DNA-Polymerase I
    • Rigby, P.W.J., Dieckmann, M., Rhodes, C. and Berg, P. (1977) Labeling deroxyribonucleic acid to high specific activity in vitro by nick translation with DNA-Polymerase I. J. Mol. Biol. 113, 237-251
    • (1977) J. Mol. Biol , vol.113 , pp. 237-251
    • Rigby, P.W.J.1    Dieckmann, M.2    Rhodes, C.3    Berg, P.4
  • 57
    • 0025317843 scopus 로고
    • Ultrafiltration to Remove Endotoxins and other Cytokine-Inducing Materials from Tissue Culture Media and Parenteral Fluids
    • Schindler, R. and Dinarello, C.A. (1990) Ultrafiltration to Remove Endotoxins and other Cytokine-Inducing Materials from Tissue Culture Media and Parenteral Fluids. Bio Techniques 8, 408-413
    • (1990) Bio Techniques , vol.8 , pp. 408-413
    • Schindler, R.1    Dinarello, C.A.2
  • 58
    • 85027639133 scopus 로고
    • Quantitation of Residual DNA in Biological Products: New Regulatory Concerns and New Methodologies
    • (Spier, R.E., Griffiths, J.B., MacDonald, C., eds.), Butterworth-Heinemann Ltd. Linacre House, Jordan Hill, Oxford 0X2 8DP
    • Smith, K.T., Doherty, I., Thomas, J. A., Per, S.R. and Sito, A.F. (1991) Quantitation of Residual DNA in Biological Products: New Regulatory Concerns and New Methodologies. In: Animal Cell Technology: Developments, Processes and Products (Spier, R.E., Griffiths, J.B., MacDonald, C., eds.), Butterworth-Heinemann Ltd. Linacre House, Jordan Hill, Oxford 0X2 8DP, pp 696-698
    • (1991) Animal Cell Technology: Developments, Processes and Products , pp. 696-698
    • Smith, K.T.1    Doherty, I.2    Thomas, J.A.3    Per, S.R.4    Sito, A.F.5
  • 59
    • 85064670825 scopus 로고    scopus 로고
    • Washington, D.C. (April 1, 1991) Code of Federal Regulations 21 CFR 600-680
    • U.S. Government Printing Office, Washington, D.C. (April 1, 1991) Code of Federal Regulations 21 CFR 600-680
  • 60
    • 85064690641 scopus 로고    scopus 로고
    • U.S. Government Printing Office, Washington, D.C. (April 1991) Code of Federal Regulations 21 CFR 210-211
    • U.S. Government Printing Office, Washington, D.C. (April 1991) Code of Federal Regulations 21 CFR 210-211
  • 61
    • 85064642223 scopus 로고
    • U.S. Pharmacopeia XXII. Walter, J. and Werner, R. G. (1993) Regulatory Requirements and Economic Aspects in Downstream Processing of Biotechnically Engineered Proteins for Parenteral Application as Pharmaceuticals
    • (Kroner, K.H., Papamichael, N. and Schütte, A., eds.), Carl Hanser Verlag, München
    • United States Pharmacopeia Convention, Inc. (1990) U.S. Pharmacopeia XXII. Walter, J. and Werner, R. G. (1993) Regulatory Requirements and Economic Aspects in Downstream Processing of Biotechnically Engineered Proteins for Parenteral Application as Pharmaceuticals. In: Downstream Processing, Recovery and Purification of Proteins. A Handbook of Principles and Practice (Kroner, K.H., Papamichael, N. and Schütte, A., eds.), Carl Hanser Verlag, München
    • (1990) Downstream Processing, Recovery and Purification of Proteins. A Handbook of Principles and Practice
  • 62
    • 0013666283 scopus 로고
    • Virus Removal and Inactivation-Concept and Data for Process Validation of Downstream Processing
    • Walter, J., Werz, W. and Berthold, W. (1992) Virus Removal and Inactivation-Concept and Data for Process Validation of Downstream Processing, Biotech Forum Europe, 9,560-564
    • (1992) Biotech Forum Europe , vol.9 , pp. 560-564
    • Walter, J.1    Werz, W.2    Berthold, W.3
  • 63
    • 84955688267 scopus 로고
    • Virus Removal/Inactivation in Downstream Processing
    • (Spier, R.E., Griffiths, J.B. and MacDonald, C., eds.), Butterworth-Heinemann Ltd. Linacre House, Jordan Hill, Oxford OX2 8DP
    • Walter, J., Werz, W., McGoff, P., Werner, R.G., Berthold, W. (1991) Virus Removal/Inactivation in Downstream Processing. In: Animal Cell Technology: Developments, Processes and Products (Spier, R.E., Griffiths, J.B. and MacDonald, C., eds.), Butterworth-Heinemann Ltd. Linacre House, Jordan Hill, Oxford OX2 8DP, pp 624-634
    • (1991) Animal Cell Technology: Developments, Processes and Products , pp. 624-634
    • Walter, J.1    Werz, W.2    McGoff, P.3    Werner, R.G.4    Berthold, W.5
  • 64
    • 85040850949 scopus 로고
    • Acceptability of cell substrates for production of Biologicals
    • WHO Study Group (1987) Acceptability of cell substrates for production of Biologicals. Geneva: World Health Organization Technical Report Series 747, pp 1-29
    • (1987) Geneva: World Health Organization Technical Report Series , vol.747 , pp. 1-29


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.