Literature Cited

  • 1
    Walsh G. Modern antibody based human therapeutics. Biopharmaceutical. 2004; 17: 1825.
  • 2
    van Dijk M,van de Winkel J. Human antibodies as next generation therapeutics. Curr Opin Chem Biol. 2001; 5: 368374.
  • 3
    Kelley B. Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnol Progr. 2007; 23: 9951008.
  • 4
    Pisano G. The Development Factory. Boston, MA: HBS Press, 1997.
  • 5
    Blank G. Monoclonal antibody purification. Presented at Recovery of Biological Products X, Cancun, Mexico, 2001.
  • 6
    Shukla A,Hubbard B,Tressel T,Guhan S,Low D. Downstream processing of monoclonal antibodies—development of platform approaches. J Chromatogr B. 2007; 848: 2839.
  • 7
    Gagnon P. Purification Tools for Monoclonal Antibodies. Tucson, AZ: Validated Biosystems, 1995.
  • 8
    Boschetti E,Jungbauer A. Separation of antibodies by liquid chromatography. In: AhujaS, editor. Handbook of Bioseparations. San Diego, CA: Academic Press, 2000: 535632.
  • 9
    Ghose S,McNerney T,Hubbard B. Protein A affinity chromatography for capture and purification of monoclonal antibodies and Fc fusion proteins: practical considerations for process development. In: ShuklaA,EtzelM,GadamS, editors. Process Scale Bioseparations for the Biopharmaceutical Industry. Boca Raton, FL: CRC Press, Taylor and Francis, 2007: 463489.
  • 10
    Ghose S,Allen M,Hubbard B,Brooks C,Cramer S. Antibody variable region interactions with Protein A: Implications for the development of generic purification processes. Biotechnol Bioeng. 2005; 92: 665673.
  • 11
    Fahrner R,Knudsen H,Basey C,Galan W,Feuerhelm D,Vanderlaan M,Blank G. Industrial purification of pharmaceutical antibodies: development, operation and validation of chromatography processes. Biotechnol Gen Engg Rev. 2001; 18: 301327.
  • 12
    Hoffman K. Strategies for host cell protein analysis. Biopharm. 2000; 13: 3845.
  • 13
    Wolter T,Richter A. Assays for controlling host-cell impurities in biopharmaceuticals. Bioprocess Int. 2005; 3: 4046.
  • 14
    Champion K,Madden H,Dougherty J,Shacter E. Defining your product profile and maintaining control over it, Part 2. Bioprocess Int. 2005; 3: 5257.
  • 15
    Krawitz DC,Forrest W,Moreno GT,Kittleson J,Champion K. Proteomic studies support the use of multi-product immunoassays to monitor host cell protein impurities. Proteomics. 2006; 6: 94110.
  • 16
    Shukla A,Peterson J,Sorge L,Lewis P,Thomas S,Waugh S. Preparative purification of a recombinant protein by hydrophobic interaction chromatography: Modulation of selectivity by the use of chaotropic additives. Biotechnol Prog. 2002; 18: 556564.
  • 17
    Follman D,Fahrner R. Factorial screening of antibody purification processes using three steps without Protein A. J Chromatogr A. 2004; 1024: 7985.
  • 18
    Phillips M,Cormier J,Ferrence J,Dowd C,Kiss R,Lutz H,Carter J. Performance of a membrane adsorber for trace impurity removal in biotechnology manufacturing. J Chromatogr A. 2005; 1078: 7482.
  • 19
    Yigzaw Y,Piper R,Tran M,Shukla A. Exploitation of the adsorptive properties of depth filters for host cell protein removal during monoclonal antibody purification. Biotechnol Prog. 2006; 22: 288296.
  • 20
    Venkiteshwaran A,Heider P,Matosevic S,Bogsnes A,Staby A,Sharfstein S,Belfort G. Optimized removal of soluble host cell proteins for the recovery of met-Human growth hormone inclusion bodies from E. coli lysate using cross-flow microfiltration. Biotechnol Prog. 2007; 23: 667672.
  • 21
    Stein A,Kiesewetter A. Cation-exchange chromatography in antibody purification: pH screening for optimized binding and HCP removal. J Chromatogr B. 2007; 848: 151158.
  • 22
    Hahn R,Schlegel R,Jungbauer A. Comparison of protein A affinity sorbents. J Chromatogr B. 2003; 790: 3551.
  • 23
    Chaddha KC,Sulkowski E. Chromatography of human leukocyte interferon on controlled pore glass. Prepar Biochem. 1981; 11: 467482.
  • 24
    Lazzareschi K,Peng D,Fahrner R,Lester P,Gorrell J,O'Leary R. An effective low cost wash buffer for the removal of host cell proteins from Protein A affinity resin. Paper presented at the American Chemical Society Meeting, Anaheim, CA, March 28–April 1, 2004.
  • 25
    Ghose S,McNerney T,Hubbard B. Preparative protein purification on underivatized silica. Biotechnol Bioeng. 2004; 87: 413423.
  • 26
    Bhuyan A. Protein stabilization by urea and guanidine hydrochloride. Biochemistry. 2002; 41: 1338613394.
  • 27
    Melander W,Horvath Cs. Salt effects on hydrophobic interactions in precipitation and chromatography of proteins: an interpretation of the lyotropic series. Arch Biochem Biophys. 1977; 183: 200215.