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Volumn 87, Issue 4, 2012, Pages 481-497

Downstream of downstream processing: Development of recycling strategies for biopharmaceutical processes

Author keywords

Biotechnology; Downstream; Membrane technology; Modelling; Recycling; Sustainability

Indexed keywords

AUXILIARY MATERIALS; BIO-PRODUCTION; BIOPHARMACEUTICAL PRODUCTS; BIOPROCESSES; BIOTECHNOLOGICAL PRODUCTION; DESIGN AND OPTIMIZATION; DOWNSTREAM; DOWNSTREAM-PROCESSING; EXPERIMENTAL MODELS; FULL INTEGRATION; INTEGRATED PROCESS; MODELLING; MULTI-STEP; PROCESS DEVELOPMENT; PROCESS ENVIRONMENT; PRODUCT CONCENTRATION; RECYCLING STRATEGY; SINGLE-STEP; SMALL SCALE; STEPWISE APPROACH;

EID: 84858289785     PISSN: 02682575     EISSN: 10974660     Source Type: Journal    
DOI: 10.1002/jctb.2727     Document Type: Article
Times cited : (13)

References (78)
  • 1
    • 56249135611 scopus 로고    scopus 로고
    • Where is biopharmaceutical manufacturing heading?
    • October
    • Jagschies G, Where is biopharmaceutical manufacturing heading? BioPharm Int October: 72-82 (2008).
    • (2008) BioPharm Int , pp. 72-82
    • Jagschies, G.1
  • 2
    • 25644438314 scopus 로고    scopus 로고
    • Challenges in production of therapeutical biologicals
    • Sommerfeld S and Strube J, Challenges in production of therapeutical biologicals. Chem Eng Process 44: 1123-1137 (2005).
    • (2005) Chem Eng Process , vol.44 , pp. 1123-1137
    • Sommerfeld, S.1    Strube, J.2
  • 3
    • 84858292943 scopus 로고    scopus 로고
    • Engpass downstream processing, transkript Nr. 10, 13. Jahrgang
    • Hubbuch J, Karau A and Kaiser K, Engpass downstream processing, transkript Nr. 10, 13. Jahrgang (2007).
    • (2007)
    • Hubbuch, J.1    Karau, A.2    Kaiser, K.3
  • 4
    • 77957130117 scopus 로고    scopus 로고
    • Levelling downstream process bottlenecks
    • DePalma A, Levelling downstream process bottlenecks. Genetic Eng Biotechnol News 30: 9 (2010).
    • (2010) Genetic Eng Biotechnol News , vol.30 , pp. 9
    • DePalma, A.1
  • 5
    • 76749120397 scopus 로고    scopus 로고
    • Purification fingerprints for experimentally based systematic downstream process development
    • Winkelnkemper T and Schembecker G, Purification fingerprints for experimentally based systematic downstream process development. Sep Purif Technol 71: 356-366 (2010).
    • (2010) Sep Purif Technol , vol.71 , pp. 356-366
    • Winkelnkemper, T.1    Schembecker, G.2
  • 8
    • 84858296663 scopus 로고    scopus 로고
    • Executives at nearly 450 global drug manufacturers weigh in on what's troubling them now, and what challenges face them ahead.
    • Langer E, Executives at nearly 450 global drug manufacturers weigh in on what's troubling them now, and what challenges face them ahead (2009)..
    • (2009)
    • Langer, E.1
  • 9
    • 84858293113 scopus 로고    scopus 로고
    • Wege durch die Bottlenecks der Biotech Produktion
    • Reutner U, Wege durch die Bottlenecks der Biotech Produktion. P&A 7: 16 (2007).
    • (2007) P&A , vol.7 , pp. 16
    • Reutner, U.1
  • 10
    • 28144437795 scopus 로고    scopus 로고
    • Protein engineering strategies for selective protein purification
    • Hedhammar M, Graslund T and Hober S, Protein engineering strategies for selective protein purification. Chem Eng Technol 28: 1315-1325 (2005).
    • (2005) Chem Eng Technol , vol.28 , pp. 1315-1325
    • Hedhammar, M.1    Graslund, T.2    Hober, S.3
  • 11
    • 84860399486 scopus 로고    scopus 로고
    • Processes development and optimization for biotechnology production-monoclonal antibodies
    • ed by Subramanian G. Wiley-VCH, 2. Auflage
    • Strube J, Sommerfeld S and Lohrmann M, Processes development and optimization for biotechnology production-monoclonal antibodies, in Bioseparation and Bioprocessing. A Handbook, ed by Subramanian G. Wiley-VCH, 2. Auflage (2007).
    • (2007) Bioseparation and Bioprocessing. A Handbook
    • Strube, J.1    Sommerfeld, S.2    Lohrmann, M.3
  • 12
    • 84858296664 scopus 로고    scopus 로고
    • New trends in pharmaceutical manufacturing waste treatment
    • Ghorpade A, New trends in pharmaceutical manufacturing waste treatment. Swiss Pharma, 11a: 31-35 (2003).
    • (2003) Swiss Pharma , vol.11 , pp. 31-35
    • Ghorpade, A.1
  • 14
    • 84858296661 scopus 로고    scopus 로고
    • Integrierte Bioprozessentwicklung-downstream of downstream processing
    • Grote F, Ditz R and Strube J, Integrierte Bioprozessentwicklung-downstream of downstream processing, Chemie Ingenieur Technik 80: 1312-1313 (2008).
    • (2008) Chemie Ingenieur Technik , vol.80 , pp. 1312-1313
    • Grote, F.1    Ditz, R.2    Strube, J.3
  • 15
    • 84858281060 scopus 로고    scopus 로고
    • Downstream of downstream processing-integrated bioprocess development from upstream to downstream
    • Grote F, Ditz R and Strube J, Downstream of downstream processing-integrated bioprocess development from upstream to downstream. Chemie Ingenieur Technik 81: 1276-1277 (2009).
    • (2009) Chemie Ingenieur Technik , vol.81 , pp. 1276-1277
    • Grote, F.1    Ditz, R.2    Strube, J.3
  • 16
    • 84858296665 scopus 로고
    • Antibody Purification, International Patent Classification 6: B01D 15/08 International Publication Number: WO95/22389, Applicant: Smithkline Beecham Corporation
    • Shadle P, Erickson J, Scott R and Smith T, Antibody Purification, International Patent Classification 6: B01D 15/08 International Publication Number: WO95/22389, Applicant: Smithkline Beecham Corporation (1985).
    • (1985)
    • Shadle, P.1    Erickson, J.2    Scott, R.3    Smith, T.4
  • 17
    • 0036244058 scopus 로고    scopus 로고
    • The role of process simulation in pharmaceutical process development and product commercialization
    • Petrides D, Koulouris A and Lagonikos P, The role of process simulation in pharmaceutical process development and product commercialization. Pharmaceut Eng 22: 1-8 (2002).
    • (2002) Pharmaceut Eng , vol.22 , pp. 1-8
    • Petrides, D.1    Koulouris, A.2    Lagonikos, P.3
  • 18
    • 0346895524 scopus 로고    scopus 로고
    • Bioprocess design and economics
    • ed by Harrison RG. Oxford University Press, New York
    • Petrides D, Bioprocess design and economics, in Bioseparations Science and Engineering, ed by Harrison RG. Oxford University Press, New York (2003).
    • (2003) Bioseparations Science and Engineering
    • Petrides, D.1
  • 19
    • 0034690093 scopus 로고    scopus 로고
    • Synthesis of bioprocesses using physical properties data
    • Steffens M, Fraga E and Bogle I, Synthesis of bioprocesses using physical properties data. Biotechnol Bioeng 68: 218-230 (2000).
    • (2000) Biotechnol Bioeng , vol.68 , pp. 218-230
    • Steffens, M.1    Fraga, E.2    Bogle, I.3
  • 20
    • 84858292957 scopus 로고    scopus 로고
    • Pharma-Wasser-Ein kritischer Rohstoff in der pharmazeutischen Verwendung
    • Kudernatsch H, Pharma-Wasser-Ein kritischer Rohstoff in der pharmazeutischen Verwendung. Pharmind: Special Issue 8a:(2002).
    • (2002) Pharmind: Special Issue , vol.8
    • Kudernatsch, H.1
  • 21
    • 84858292954 scopus 로고    scopus 로고
    • EMA, Note for Guidance on Quality of Water for Pharmaceutical Use. 1. Juni.
    • EMA, Note for Guidance on Quality of Water for Pharmaceutical Use. 1. Juni (2002)..
    • (2002)
  • 24
    • 0037257747 scopus 로고    scopus 로고
    • Regelwerke zur Herstellung von Pharmawasser und Behördeninspektionen von Wassersystemen
    • Feuerhelm K, Regelwerke zur Herstellung von Pharmawasser und Behördeninspektionen von Wassersystemen. Pharm Ind 65: 276-328 (2003).
    • (2003) Pharm Ind , vol.65 , pp. 276-328
    • Feuerhelm, K.1
  • 25
    • 84858296660 scopus 로고    scopus 로고
    • Verordnung zur Novellierung der Trinkwasserverordnung vom 21. MaiDVGW
    • Verordnung zur Novellierung der Trinkwasserverordnung vom 21. Mai (2001). DVGW,.
    • (2001)
  • 26
    • 84858292950 scopus 로고    scopus 로고
    • ISPE, Good Practice Guide, Commissioning and qualification of pharmaceutical water steam systems. International Society for Pharmaceutical Engineering
    • ISPE, Good Practice Guide, Commissioning and qualification of pharmaceutical water steam systems. International Society for Pharmaceutical Engineering (2007).
    • (2007)
  • 27
    • 84858292948 scopus 로고    scopus 로고
    • FDA, Guide to Inspections of High Purity Water Systems
    • FDA, Guide to Inspections of High Purity Water Systems, (2004).
    • (2004)
  • 28
    • 84858292955 scopus 로고    scopus 로고
    • European Pharmacopoeia 6.0
    • European Pharmacopoeia 6.0 (2008).
    • (2008)
  • 29
    • 84858294565 scopus 로고    scopus 로고
    • US Pharmacopoeia 33 NF 28.
    • US Pharmacopoeia 33 NF 28.
  • 30
    • 84858292949 scopus 로고    scopus 로고
    • Herstellung von Pharmawasser
    • T. Berger, Verlag, Editio Cantor; 1, Aufl.
    • Bendlin H, Herstellung von Pharmawasser, Good Engineering Practice, T. Berger, Verlag, Editio Cantor; 1, Aufl. (2006).
    • (2006) Good Engineering Practice
    • Bendlin, H.1
  • 31
    • 84858292952 scopus 로고    scopus 로고
    • Control of pharmaceuticals
    • Informa Healthcare, Marcel Dekker Inc., New York
    • Hall NA, Control of pharmaceuticals, in Encyclopedia of Pharmaceutical Technology, Vol. 4 Informa Healthcare, Marcel Dekker Inc., New York (2006).
    • (2006) Encyclopedia of Pharmaceutical Technology, , vol.4
    • Hall, N.A.1
  • 32
    • 84858294564 scopus 로고    scopus 로고
    • Japanese Pharmacopoeia, 14th edn..
    • Japanese Pharmacopoeia, 14th edn..
  • 33
    • 0028083504 scopus 로고
    • Purifying water for biotechnology: a case study
    • Cross J and Wood L, Purifying water for biotechnology: a case study. Process Biochem 29: 449-453 (1994).
    • (1994) Process Biochem , vol.29 , pp. 449-453
    • Cross, J.1    Wood, L.2
  • 34
    • 84858292951 scopus 로고    scopus 로고
    • International standards for pharmaceutical waters
    • May
    • Bevilacqua AC, International standards for pharmaceutical waters. Elga News May (2005).
    • (2005) Elga News
    • Bevilacqua, A.C.1
  • 35
    • 0442329223 scopus 로고    scopus 로고
    • Prozesssimulation zur frühen ökologischen Bewertung biotechnologischer Prozesse
    • Heinzle E and Biwer A, Prozesssimulation zur frühen ökologischen Bewertung biotechnologischer Prozesse. Chemie Ingenieur Technik 73: 1467-1472 (2001).
    • (2001) Chemie Ingenieur Technik , vol.73 , pp. 1467-1472
    • Heinzle, E.1    Biwer, A.2
  • 37
    • 2642573356 scopus 로고    scopus 로고
    • Simulation und ökologische Bewertung in der Entwicklung biotechnologischer Prozesse
    • Biwer A, Simulation und ökologische Bewertung in der Entwicklung biotechnologischer Prozesse. Modellbildung (2003).
    • (2003) Modellbildung
    • Biwer, A.1
  • 38
    • 33744966875 scopus 로고    scopus 로고
    • Technical and economical evaluation of downstream processing options for monoclonal antibody production. Supplement to Biopharm International June:10-19
    • Jagschies G, Grönberg A, Björkman T, Lacki K and Hohannson H, Technical and economical evaluation of downstream processing options for monoclonal antibody production. Supplement to Biopharm International June:10-19 (2006).
    • (2006)
    • Jagschies, G.1    Grönberg, A.2    Björkman, T.3    Lacki, K.4    Hohannson, H.5
  • 39
    • 35348866110 scopus 로고    scopus 로고
    • Very large scale monoclonal antibody purification: the case conventional unit operations
    • Kelley B, Very large scale monoclonal antibody purification: the case conventional unit operations. Biotechnol Prog 23: 995-1008 (2007).
    • (2007) Biotechnol Prog , vol.23 , pp. 995-1008
    • Kelley, B.1
  • 40
    • 59649094826 scopus 로고    scopus 로고
    • Life cost analysis for single-use systems
    • November
    • Barnoon BI and Bader B, Life cost analysis for single-use systems. Biopharm Int November (2008).
    • (2008) Biopharm Int
    • Barnoon, B.I.1    Bader, B.2
  • 42
    • 84858277595 scopus 로고    scopus 로고
    • st Century-A Risk-based Approach. Final Report.
    • st Century-A Risk-based Approach. Final Report (2004)..
    • (2004)
  • 43
    • 84858294563 scopus 로고    scopus 로고
    • Guidance for Industry, Quality Systems Approach to Pharmaceutical cGMP Regulations.
    • Guidance for Industry, Quality Systems Approach to Pharmaceutical cGMP Regulations (2006)..
    • (2006)
  • 45
    • 84858277594 scopus 로고    scopus 로고
    • FDA Guidance Concerning Demonstration on Comparability of Human Biological Products, including Therapeutic Biotechnology-derived Products.
    • FDA Guidance Concerning Demonstration on Comparability of Human Biological Products, including Therapeutic Biotechnology-derived Products (1996)..
    • (1996)
  • 46
    • 84858296656 scopus 로고    scopus 로고
    • Comparability of Biotechnological Products Subjects to Change in their Manufacturing Process, Q5E.
    • Comparability of Biotechnological Products Subjects to Change in their Manufacturing Process, Q5E (2005)..
    • (2005)
  • 47
    • 84858296655 scopus 로고    scopus 로고
    • Guidline on Similar Biological Medicine Products.
    • Guidline on Similar Biological Medicine Products (2005)..
    • (2005)
  • 48
    • 84858277596 scopus 로고    scopus 로고
    • Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substances: Quality Issues.
    • Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substances: Quality Issues (2006)..
    • (2006)
  • 49
    • 33847793307 scopus 로고    scopus 로고
    • Future of antibody purification
    • Low D, O'Leary R and Pujar N, Future of antibody purification. J Chromatogr B 848: 48-63 (2007).
    • (2007) J Chromatogr B , vol.848 , pp. 48-63
    • Low, D.1    O'Leary, R.2    Pujar, N.3
  • 50
    • 84858294560 scopus 로고    scopus 로고
    • Process Analytical Technologies Initiative.
    • Process Analytical Technologies Initiative (2008)..
    • (2008)
  • 51
    • 84858277593 scopus 로고    scopus 로고
    • Guidance for Industry PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.
    • Guidance for Industry PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (2004)..
    • (2004)
  • 54
    • 80051847678 scopus 로고    scopus 로고
    • Miniplant-technik
    • Wiley-VCH, Auflage 1. Auflage
    • Deibele L and Dohrn R, Miniplant-technik, in Prozessindustrie. Wiley-VCH, Auflage 1. Auflage (2006).
    • (2006) Prozessindustrie.
    • Deibele, L.1    Dohrn, R.2
  • 55
    • 79955043893 scopus 로고    scopus 로고
    • Integration of ultrafiltration unit operations in biotechnology process design
    • Grote F, Fröhlich H and Strube J, Integration of ultrafiltration unit operations in biotechnology process design. Chem Eng Technol 34: 673-687 (2011).
    • (2011) Chem Eng Technol , vol.34 , pp. 673-687
    • Grote, F.1    Fröhlich, H.2    Strube, J.3
  • 56
    • 0036706850 scopus 로고    scopus 로고
    • Modeling ultrafiltration of complex biological solutions
    • Darnon E, Belleville MP and Rios GM, Modeling ultrafiltration of complex biological solutions. AIChE J 48: 1727-1736 (2002).
    • (2002) AIChE J , vol.48 , pp. 1727-1736
    • Darnon, E.1    Belleville, M.P.2    Rios, G.M.3
  • 57
    • 0015523306 scopus 로고
    • Proteolytic degradation of IgD and its relation to molecular conformation
    • Griffiths RW and Gleich GJ, Proteolytic degradation of IgD and its relation to molecular conformation. J. Biol Chem 247: 4543-4548 (1972).
    • (1972) J. Biol Chem , vol.247 , pp. 4543-4548
    • Griffiths, R.W.1    Gleich, G.J.2
  • 58
    • 79955043893 scopus 로고    scopus 로고
    • Integration of reverse osmosis unit operations in biotechnology process design
    • submitted
    • Grote F, Fröhlich H and Strube J, Integration of reverse osmosis unit operations in biotechnology process design. Chem Eng Technol submitted (2011).
    • (2011) Chem Eng Technol
    • Grote, F.1    Fröhlich, H.2    Strube, J.3
  • 60
    • 33746789888 scopus 로고    scopus 로고
    • Reduction of random and systematic errors of test cell measurement
    • Jezowsla A, Schipolowski T and Wozny G, Reduction of random and systematic errors of test cell measurement. Desalination 200: 160-162 (2006).
    • (2006) Desalination , vol.200 , pp. 160-162
    • Jezowsla, A.1    Schipolowski, T.2    Wozny, G.3
  • 61
    • 84858294863 scopus 로고    scopus 로고
    • Untersuchung zum Einfluss von Membranmodifizierung auf das Fouling unter der Berücksichtigung des "critical flux"
    • Meier-Haack J, Untersuchung zum Einfluss von Membranmodifizierung auf das Fouling unter der Berücksichtigung des "critical flux". Newsletter SIMA-Tec 3: 1-5 (2007).
    • (2007) Newsletter SIMA-Tec , vol.3 , pp. 1-5
    • Meier-Haack, J.1
  • 62
    • 33144482755 scopus 로고    scopus 로고
    • Influence of simple pre-treatment methods on properties of membrane material
    • Jezowsla A, Schipolowski T and Wozny G, Influence of simple pre-treatment methods on properties of membrane material. Desalination 189: 43-52 (2006).
    • (2006) Desalination , vol.189 , pp. 43-52
    • Jezowsla, A.1    Schipolowski, T.2    Wozny, G.3
  • 63
    • 0037056606 scopus 로고    scopus 로고
    • Effect of temperature and membrane pre-treatment by pressure on the filtration properties of nanofiltration membranes
    • Mänttäri M, Pihlajamäki A, Kaipainen E and Nyström M, Effect of temperature and membrane pre-treatment by pressure on the filtration properties of nanofiltration membranes. Desalination 145: 81-86 (2002).
    • (2002) Desalination , vol.145 , pp. 81-86
    • Mänttäri, M.1    Pihlajamäki, A.2    Kaipainen, E.3    Nyström, M.4
  • 64
    • 0031127369 scopus 로고    scopus 로고
    • Evaluation of nanofiltration membranes for filtration of paper mill total effluent
    • Mänttäri M, Nuortila-Jokinen J and Nyström M, Evaluation of nanofiltration membranes for filtration of paper mill total effluent. Filtr Sep 34: 275-280 (1997).
    • (1997) Filtr Sep , vol.34 , pp. 275-280
    • Mänttäri, M.1    Nuortila-Jokinen, J.2    Nyström, M.3
  • 65
    • 0027904896 scopus 로고
    • Ultrafiltration of whey protein solutions in spacer-filled flat channels
    • Costa AR, Fane AG and Wiley DE, Ultrafiltration of whey protein solutions in spacer-filled flat channels. J Membr Sci 76: 245-254 (1993).
    • (1993) J Membr Sci , vol.76 , pp. 245-254
    • Costa, A.R.1    Fane, A.G.2    Wiley, D.E.3
  • 67
  • 68
    • 0023435260 scopus 로고
    • Insulin production technology
    • Barfoed H, Insulin production technology. Chem Eng Prog 83: 49-54 (1987).
    • (1987) Chem Eng Prog , vol.83 , pp. 49-54
    • Barfoed, H.1
  • 69
    • 84858290172 scopus 로고    scopus 로고
    • Feasibility of international technology transfer for the production of recombinant human insulin
    • Klyushnichenko V, Bruch R, Bulychev A, Ditsch A, Pernenkil L and Tao F, Feasibility of international technology transfer for the production of recombinant human insulin. Bioprocess Int 8: 48-59 (2004).
    • (2004) Bioprocess Int , vol.8 , pp. 48-59
    • Klyushnichenko, V.1    Bruch, R.2    Bulychev, A.3    Ditsch, A.4    Pernenkil, L.5    Tao, F.6
  • 70
    • 34547226055 scopus 로고    scopus 로고
    • Modeling and optimization of preparative reversed-phase liquid chromatography for insulin purification
    • Degermann M, Jakobsson N and Nilson B, Modeling and optimization of preparative reversed-phase liquid chromatography for insulin purification. J Chromatogr A 1162: 41-49 (2007).
    • (2007) J Chromatogr A , vol.1162 , pp. 41-49
    • Degermann, M.1    Jakobsson, N.2    Nilson, B.3
  • 71
    • 84858294379 scopus 로고    scopus 로고
    • Vom Rinder-, Schweine-, Pferde-Insulin zum Humaninsulin: Die biotechnische und gentechnische Insulin-Herstellung
    • Zündorf I and Dingermann T, Vom Rinder-, Schweine-, Pferde-Insulin zum Humaninsulin: Die biotechnische und gentechnische Insulin-Herstellung, Pharmazie in unserer zeit Nr. 1, 30:(2001).
    • (2001) Pharmazie in unserer zeit Nr. 1 , vol.30
    • Zündorf, I.1    Dingermann, T.2
  • 72
    • 0024494453 scopus 로고
    • Production scale purification of biosynthetic human insulin by reversed phase high performance liquid chromatography
    • Kroeff E, Owens R, Campbell E, Johnson R and Marks H, Production scale purification of biosynthetic human insulin by reversed phase high performance liquid chromatography. J Chromatogr 461: 45-61 (1984).
    • (1984) J Chromatogr , vol.461 , pp. 45-61
    • Kroeff, E.1    Owens, R.2    Campbell, E.3    Johnson, R.4    Marks, H.5
  • 74
    • 17644400255 scopus 로고    scopus 로고
    • Antibiotics
    • Cambridge University Press, Cambridge
    • Lowe D, Antibiotics, in Basic Biotechnology. Cambridge University Press, Cambridge, 349-375 (2001).
    • (2001) Basic Biotechnology , pp. 349-375
    • Lowe, D.1
  • 78
    • 0036196260 scopus 로고    scopus 로고
    • Simulated foam separation of butyl acetate from wastewater discharged by solvent extraction operation in penicillin production
    • Chang Z, Wie X and Chen J, Simulated foam separation of butyl acetate from wastewater discharged by solvent extraction operation in penicillin production. Sep Sci Technol 37: 981-991 (2002).
    • (2002) Sep Sci Technol , vol.37 , pp. 981-991
    • Chang, Z.1    Wie, X.2    Chen, J.3


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