References and Notes

  • 1
    Wurm, F. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat. Biotechnol. 2004, 22, 16.
  • 2
    Kelley, B. Designing a 10 ton antibody process: Is conventional chromatography limiting? 232nd American Chemical Society National Meeting, Sept 10–14, 2006, San Francisco, CA; BIOT division, paper 133.
  • 3
    Gottschalk, U. Downstream processing of monoclonal antibodies: from high dilution to high purity. BioPharm. Int. 2005, 18, 4258.
  • 4
    Thommes, J.; Etzel, M. Alternatives to chromatographic separations. Biotechnol. Prog. 2007, 23, 4245.
  • 5
    BioPlan Associates and BioProcess Technology Consultants. Third Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production; BioPlan Associates: Rockville, MD, 2005.
  • 6
    BioPlan Associates and BioProcess Technology Consultants. Fourth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production; BioPlan Associates: Rockville, MD, 2006.
  • 7
    Langer, E.; Ranck, J. Capacity bottleneck squeezed by downstream processes. BioProcess Int. 2006, 19, 1418.
  • 8
    Shukla, A.; Hubbard, B.; Tressel, T.; Guhan, S.; Low, D. Downstream processing of monoclonal antibodies-application of platform approaches. J. Chromatogr. B 2007, 848, 2839.
  • 9
    Gottschalk, U. New and unknown challenges facing biomanufacturing. BioPharm. Int. 2005, 18, 2428.
  • 10
    Curling, J.; Gottschalk, U. Process chromatography: Five decades of innovation. BioPharm. Int. 2007, 20, 1019.
  • 11
    Desai, M. A.; Rayner, M.; Burns, M.; Bermingham, D. Application of chromatography in the downstream processing of biomolecules. In Downstream Processing of Proteins: Methods and Protocols; Desai, A. M., Ed.; Methods Biotechnol. 2000, 9, 7394.
  • 12
    Morrow K. J. Improvingprotein production processes. Genet. Eng. Biotechnol. News 2007, August, 4447.
  • 13
    Low, D.; O'Leary, R.; Pujar, N. S. Future of antibody purification. J. Chromatogr. B 2007, 848, 4863.
  • 14
    Kelley, B. Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnol. Prog. 2007, 23, 9951008.
  • 15
    Kamarck M. E. Buildingbiomanufacturing capacity-the chapter and verse. Nat. Biotechnol. 2006, 24, 503505.
  • 16
    Reichert, U.; Linden, T.; Belfort, G.; Kula, M.-R.; Thömmes, J. Visualising protein adsorption to ion-exchange membranes by confocal microscopy. J. Membr. Sci. 2002, 199, 161166.
  • 17
    Hubbuch, J.; Linden, T.; Knieps, E.; Thömmes, J.; Kula M.-R. Mechanismand kinetics of protein transport in chromatographic media studied by confocal laser scanning microscopy: Part II. Impact on chromatographic separations. J. Chromatogr. A 2003, 1021, 105115.
  • 18
    Przybycien, T. M.; Pujar, N. S.; Steele, L. M. Alternative bioseparation operations: life beyond packed-bed chromatography. Curr. Opin. Biotechnol. 2004, 15, 469478.
  • 19
    Ahamed, T.; Esteban, B. N. A.; Ottens, M.; van Dedem, G. W. K.; van der Wielen, L. A. M.; Bisschops, M. A. T.; Lee, A.; Pham, C.; Thömmes, J. Phase behavior of an intact monoclonal antibody. Biophys. J. 2007, 93, 610619.
  • 20
    Coffman, J.; Shpritzer, R.; Vicik, S. Flocculation of antibody-producing mammalian cells with precipitating solutions of soluble cations and anions. Recovery of Biological Products X II, April 2–7, 2006, Litchfield, AZ.
  • 21
    Shpritzer, R.; Vicik, S.; Orlando, S.; Acharya, H.; Coffman, J. Calcium phosphate flocculation of antibody-producing mammalian cells at pilot scale. 232nd American Chemical Society National Meeting, Sept 10–14, 2006, San Francisco, CA; BIOT division, paper 80.
  • 22
    Etzel, M. Bulk protein crystallization — Principles and methods. In: Shukla, A., Etzel, M., Gadam, S., Eds. Process Scale Bioseparations for the Biopharmaceutical Industry; Taylor & Francis: Boca Raton, FL, 2006.
  • 23
    Flores, H.; Lin, T.; Matthews, T.; Pai, R.; Shahrokh, Z. Apo-2 ligand/trail formulations. U.S. Patent Application 20060009387 A1, Jan 12, 2006.
  • 24
    Peters, J.; Minuth, T.; Schroder, W. Implementation of a crystallization step into the purification process of a recombinant protein. Protein Expression Purif. 2005, 39, 4353.
  • 25
    Gottschlich, N.; Kasche, V. Purification of monoclonal antibodies by simulated moving-bed chromatography. J. Chromatogr. A 1997, 765, 201206.
  • 26
    Nakao, S.; Osada, H.; Kurata, H.; Tsuru, T.; Kimura, S. Separation of proteins by charged ultrafiltration membranes. Desalination 1988, 70, 191205.
  • 27
    van Reis, R.; Gadam, S.; Frautschy, L.; Orlando, S.; Goodrich, E.; Saksena, S.; Kuriyel, R.; Simpson, C.; Pearl, S.; Zydney, A. High performance tangential flow filtration. Biotechnol. Bioeng. 1997, 56, 7182.
  • 28
    van Reis, R.; Brake, J.; Charkoudian, J.; Burns, D.; Zydney, A. High-performance tangential flow filtration using charged membranes. J. Membr. Sci. 1999, 159, 133142.
  • 29
    van Reis, R. Charged filtration membranes and uses thereof. U.S. Patent 7,001,552 B2, Feb 21, 2006.
  • 30
    Tennikova, T. B.; Reusch, J. Short monolith beads: history and introduction to the field. J. Chromatogr. A 2005, 1065, 1317.
  • 31
    Thömmes, J.; Kula M.-R. Membranechromatography. An integrative concept in the downstream processing of proteins. Biotechnol. Prog. 1995, 11, 357367.
  • 32
    Knudsen, H.; Fahrner, R.; Xu, Y.; Norling, L.; Blank, G. Membrane ion-exchange chromatography for process-scale antibody purification. J. Chromatogr. A 2001, 907, 145154.
  • 33
    Mora, J.; Sinclair, A.; Delmdahl, N.; Gottschalk, U. Disposable membrane chromatography. Performance analysis and economic cost model. Bioprocess Int. 2006, 4(Suppl 4), 3843.
  • 34
    Zhou, J.; Tressel, T. Basic concepts in Q membrane chromatography for large-scale antibody production. Biotechnol. Prog. 2006, 22, 341349.
  • 35
    Etzel, M.; Riordan, W. Membrane chromatography: Analysis of breakthrough curves and viral clearance. In Process Scale Bioseparations for the Biopharmaceutical Industry; Shukla, A., Etzel, M., Gadam, S., Eds.; Taylor & Francis: Boca Raton, FL, 2006.
  • 36
    Walter J. K. Strategiesand considerations for advanced economy in downstream processing of biopharmaceutical proteins. In Bioseparation and Bioprocessing. Processing, Quality and Characterization, Economics, Safety and Hygiene; Subramanian, G., Ed.; Wiley-VCH: Weinheim, 1998; pp 447460.
  • 37
    Curtis, S.; Lee, K.; Blank, G.; Brorson, K.; Xu, Y. Generic/matrix evaluation of SV40 clearance by anion exchange chromatography in flow-through mode. Biotechnol. Bioeng. 2003, 84, 179186.
  • 38
    Norling, L.; Lute, S.; Emery, R.; Khuu, W.; Voisard, M.; Xu, Y.; Chen, Q.; Blank, G.; Brorson, K. Impact of multiple reuse of anion exchange chromatography media on virus removal. J. Chromatogr. 2005, 1069, 7989.
  • 39
    Gottschalk, U.; Lamproye, A.; Zhou, J.; Sinclair, A.; Reif O.-W. Anintegrated platform for robust virus and contaminant removal in biomanufacturing. Recovery of Biological Products X II, Phoenix, Arizona, April 2–7, 2006.
  • 40
    Gosh, R. Protein separation using membrane chromatography: opportunities and challenges. J. Chromatogr. A 2002, 952, 1327.
  • 41
    Gebauer, K.; Thommes, J.; Kula, M. Plasma protein fractionation with advanced membrane adsorbents. Biotechnol. Bioeng. 1997, 54, 181189.
  • 42
    Zhang, R.; Bouamama, T.; Tabur, R.; Zapata, G. A. Q membrane chromatography application for human antibody purification process. BioProduction 2004.
  • 43
    Farb, D. Platform for generic validation of virus removal steps. Downstream Technology Forum, King of Prussia, Pennsylvania, September 28, 2006.
  • 44
    Zhou, J. Disposable anionic membrane chromatography. IBC Technology Transfer for Biopharmaceuticals, Carlsbad, CA, March, 2006.
  • 45
    Sinclair, A.; Monge, M. Quantitative economic evaluation of single use disposables in bioprocessing. Pharmaceut. Eng. 2002, 22, 2034.
  • 46
    Lim, J. A. C.; Sinclair, A.; Kim, D. S.; Gottschalk, U. Economic benefits of single-use membrane chromatography in polishing. A cost of goods model. BioProcess. Int. 2007, 5, 6064.
  • 47
    EMEA. Guideline on virus safety evaluation of biotechnological investigational medicinal products. EMEA/CHMP/BWP/398498/2005-corr. EMEA: London, 2006.
  • 48
    Gottschalk, U. The Renaissance of protein purification. Biopharm. Int. 2006, 19(suppl 2), 89.
  • 49
    Arunakumari, A. Downstream design considerations for efficient batch processing of high titer cell culture processes for the production of monoclonal antibodies. BioProcess International European Conference and Exhibition, Paris, France April 24–25, 2007.
  • 50
    Zhou, J.; Tressel, T.; Solamo, F.; Dermawan, S.; Hong, T.; Gottschalk, U.; Reif, O.; Pastor, A.; Mora, J.; Hutchison, F.; Murphy, M. A new Sartobind Q scale-down model for process-scale antibody purification. J. Chromatogr. A 2006, 1134, 6673.