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References and Notes

  • 1
    ICH Q6B. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products; International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Geneva, 1999.
  • 2
    Kelner, D. N.; Bhalgat, M. Analytical strategy for biopharmaceutical development. In Process Scale Bioseparations for the Biopharmaceutical Industry; Shukla, A., Gadam, S., Etzel, M., Eds.; CRC Press Taylor and Francis: Boca Raton, FL, 2007; pp 395418.
  • 3
    Champion, K.; Madden, H.; Dougherty, J.; Shacter, E. Define your product profile and maintaining control over it, part 2: Challenges of monitoring host cell protein impurities. BioProcess Int. 2005, 3, 5257.
  • 4
    Eaton, L. Host cell contaminant protein assay development for recombinant biopharmaceuticals. J. Chromatogr. 1995, 705, 105114.
  • 5
    Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use; Food and Drug Administration: Rockville, MD, 1997.
  • 6
    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.
  • 7
    Gagnon, P. Polishing methods for monoclonal IgG purification. In Process Scale Bioseparations for the Biopharmaceutical Industry; Shukla, A., Gadam, S., Etzel, M., Eds.; CRC Press Taylor and Francis: Boca Raton, FL, 2007; pp 491505.
  • 8
    Follman, D.; Fahrner, R. L. Factorial screening of antibody purification processes using three chromatography steps without Protein A. J. Chromatogr. A 2004, 1024, 7985.
  • 9
    Shukla, A.; Hubbard, B.; Tressel, T.; Guham, S.; Low, D. Downstream processing of monoclonal antibodies-application of platform approaches. J. Chromatogr. B 2007, 848, 2839.
  • 10
    Kelley, B. Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnol. Prog. 2007, 23, 9951008.
  • 11
    Knudsen, H. L.; Fahrner, R. L.; Xu, Y.; Norling, L. A.; Blank, G. S. Membrane ion-exchange chromatography for process-scale antibody purification. J. Chromatogr. A 2001, 907, 145154.
  • 12
    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.
  • 13
    Riske, F.; Smith, M.; Menon, M.; Goetschalk, S.; Goidsenhoven, I. V.; Krul, A.; Pimpaneau, V.; Renaers, I.; Tichelt, N. V.; Houdt, K. V.; Hayes, M.; Lawrence, C.; Bigelow, R.; Schroeder, J. A potential generic downstream process using Cibacron Blue resin at very high loading capacity produces a highly purified monoclonal antibody preparation from cell culture harvest. J. Chromatogr. B 2007, 848, 108115.
  • 14
    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.
  • 15
    Stein, A.; Kiesewetter, A. Cation-exchange chromatography in antibody purification: pH screening for optimized binding and HCP removal. J. Chromatogr. B 2007, 848, 151158.
  • 16
    Briggs, J.; Panfili, P. R. Quantitation of DNA and protein impurities in biopharmaceuticals. Anal. Chem. 1991, 63, 850859.
  • 17
    Krawitz, D. C.; Forrest, W.; Moreno, G. T.; Kittleson, J.; Champion, K. Proteomic studies support the use of multi-product immunoassays to monitor host cell protein impurities. Proteomics 2006, 6, 94110.
  • 18
    Rathore, A. S.; Sobacke, S. E.; Kocot, T. J.; Morgan, D. R.; Dufield, R. L.; Mozier, N. M. Analysis for residual host cell proteins and DNA in process streams of a recombinant protein product expressed in E. Coli. J. Pharm. Biomed. Anal. 2003, 32, 11991211.
  • 19
    Zhu, D.; Saul, A. J.; Miles, A. P. A quantitative slot-blot assay for host cell protein impurities in recombinant proteins expressed in E. Coli. J. Immunol. Methods 2005, 306, 4050.
  • 20
    Ahrer, K.; Jungbauer, A. Chromatographic and electrophoretic characterization of protein variants. J. Chromatogr. B 2006, 841, 110122.
  • 21
    Wolter, T.; Richter, A. Assays for controlling host-cell impurities in biopharmaceuticals. BioProcess Int. 2005, 3 ( 2), 4046.
  • 22
    Smith, T. M.; Wilson, E.; Scott, R. G.; Miscak, J. W.; Bodek, J. M.; Zabriskie, D. W. Establishment of operating ranges in a purification process for a monoclonal antibody. In Validation of Biopharmaceutical Manufacturing Processes; Kelley, B. D., Ramelmeier, R. A., Eds.; ACS Symposium Series; American Chemical Society: Washington, DC, 1998; Vol. 698, pp 8092.
  • 23
    CPMP Position Statement on DNA and HCPs, Routine Testing vs. Validation Studies; EMEA: London, 1997.
  • 24
    Fahrner, R. L.; Knudsen, H. L.; Basey, C. D.; Galan, W.; Feuerhelm, D.; Vanderlaan, M.; Blank, G. S. Industrial purification of pharmaceutical antibodies: development, operation and validation of chromatography processes. Biotechnol. Genet. Eng. Rev. 2001, 18, 301327.
  • 25
    Conley, L.; McPherson, J.; Thommes J. Validation of the Zevalin purification process-a case study. In Process Validation in Manufacturing of Biopharmaceuticals; Rathore, A., Sofer, G., Eds.; CRC Press Taylor and Francis: Boca Raton, FL, 2005; pp 469521.
  • 26
    Rubino, M.; Bailey, M.; Baker, J. C.; Boose, J. A.; Metzka, L.; Moore, V.; Quertinmont, M.; Wiler, W. Viral clearance validation: a case study. In Process Validation in Manufacturing of Biopharmaceuticals; Rathore, A., Sofer, G., Eds.; CRC Press Taylor and Francis: Boca Raton, FL, 2005; pp 545563.
  • 27
    Kelley, B. Establishing Process Robustness Using Designed Experiments. In Biopharmaceutical Process Validation; Sofer, G., Zabriskie, D., Eds.; Marcel Dekker: New York, 2000; pP 29.
  • 28
    Gardner, A. R.; Smith, T. M.; Gerber, R. G.; Zabriskie, D. W. Worst-case approach to validation of operating ranges. In Validation of Biopharmaceutical Manufacturing Processes; Kelley, B. D., Ramelmeier, R. A., Eds.; ACS Symposium Series 698; American Chemical Society: Washington, DC, 1998; pp 6979.
  • 29
    Seeley, J. Process Characterization. In Process Validation in Manufacturing of Biopharmaceuticals; Rathore, A., Sofer, G., Eds.; CRC Press Taylor and Francis: Boca Raton, FL, 2005; pp 3167.
  • 30
    ICH Q7. Guideline on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients; International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Geneva, 2000.