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References

  • Anderson NL, Anderson NG. 2002. The human plasma proteome: History, character, and diagnostic prospects. Mol Cell Proteomics 1: 845867.
  • Anicetti VR, Fehskens EF, Reed BR, Chen AB, Moore P, Geier MD, Jones AJS. 1986. Immunoassay for the detection of E. coli proteins in recombinant DNA derived human growth hormone. J Immunol Methods 91: 213224.
  • Belov ME, Anderson GA, Angell NH, Shen Y, Tolic N, Udseth HR, Smith RD. 2001. Dynamic range expansion applied to mass spectrometry based on data-dependent selective ion ejection in capillary liquid chromatography fourier transform ion cyclotron resonance for enhanced proteome characterization. Anal Chem 73: 50525060.
  • Blattner FR, Plunkett G III, Bloch CA, Perna NT, Burland V, Riley M, Collado-Vides J, Glasner JD, Rode CK, Mayhew GF, et al. 1997. The complete genome sequence of Escherichia coli K-12. Science 277(5331): 14531474.
  • Briggs J, Panfili PR. 1991. Quantitation of DNA and protein impurities in biopharmaceuticals. Anal Chem 63: 850859.
  • Champion K, Nishihara JC, Joly JC, Arnott D. 2001. Similarity of the Escherichia coli proteome upon completion of different biopharmaceutical fermentation process. Proteomics 1: 11331148.
  • Champion K, Madden H, Dougherty J, Shacter E. 2005. Defining your product profile and maintaining control over it, part 2. BioProcess Int 3(8): 5257.
  • Crowther JR. 2001. The ELISA guidebook. Totowa, NJ: Humana Press.
  • Dagouassat N, Haeuw J-F, Robillard V, Damien F, Libon C, Corvaia N, Lawny F, Nguyen TN, Bonnefoy J-Y, Beck A. 2001. Development of a quantitative assay for residual host cell proteins in a recombinant subunit vaccine against human respiratory syncytial virus. J Immunol Methods 251: 151159.
  • Dyk DDV, Misztal DR, Wiljkins MR, Mackintosh JA, Poljak A, Varnai JC, Teber E, Walsh BJ, Gray PP. 2003. Identification of cellular changes associated with increased production of human growth hormone in a recombinant Chinese hamster overy cell line. Proteomics 3: 147156.
  • Eaton LC. 1995. Host cell contaminant protein assay development for recombinant biopharmaceuticols. J Chromatogr A 705: 105114.
  • EMEA. 1997. CPMP position statement on DNA and Host Cell Proteins (HCP) impurities, routine testing versus validation studies. London: European Medicines Agency.
  • FDA. 1997. Points to consider in the manufacture and testing of monoclonal antibody products for human use. www.fda.gov/CBER/gdlns/ptc_mab.pdf.
  • Follman DK, Fahrner RL. 2004. Factorial screening of antibody purification processes using three chromatography steps without protein A. J Chromatogr A 1024: 7985.
  • Gibbs RA, Weinstock GM, Metzker ML, et al. 2004. Genome sequence of the Brown Norway rat yields insights into mammalian evolution. Nature 428: 493521.
  • Godovac-Zimmermann J, Brown LR. 2001. Perspectives for mass spectrometry and functional proteomics. Mass Spectrom Rev 20: 157.
  • Goffeau A. 1997. The yeast genome directory. Nature 387: 5.
  • Groote DD, Zangerle PF, Gevaert Y, Fassotte MF, Bequin Y, Noizat-Pirenne F, Pirenne J, Gathy R, Lopez M, Dehart I, et al. 1992. Direct stimulation of cytokines (IL-1β, TNF-α, IL-6, IL-2, IFN-γ, and GM-CSF) in whole blood I. Comparison with isolated PBMC stimulation. Cytokine 4(3): 239248.
  • Hart RA, Rinas U, Bailey JE. 1990. Protein composition of vitreoscilla hemoglobin inclusion bodies produced in Escherichia coli. J Biol Chem 265(21): 1272812733.
  • Hayduk EJ, Choe LH, Lee KH. 2004. A two-dimensional electrophoresis map of Chinese hamster ovary cell proteins based on fluorescence staining. Electrophoresis 25: 25452556.
  • Hoffman K. 2000. Strategies for host cell protein analysis. BioPharm 13(6): 3845.
  • House RV. 2001. Cytokine measurement techniques for assessing hypersensitivity. Toxicology 158: 5158.
  • Hunter AK, Hoeltzli SD, Johnson GV, Gustafson ME, Ho SV. 2008. Use of cyclohexanedimethanol as a nonflammable organic solvent for industrial scale reversed phase chromatography. J Chromatogr A 1202: 107110.
  • Hunter AK, Wang X, Suda EJ, Herberg JT, Shell RE, Thomas KE, Gustafson ME, Mozier NM, Ho SV. 2009. Separation of product associating E. coli host cell proteins OppA and DppA from recombinant apolipoprotein A-IMilano in an industrial HIC unit operation. Biotechnol Prog. DOI: 10.1002/btpr.106.
  • ICH. 1999. Guidance for Industry Q6B Specifications: Test procedures and acceptance criteria for biotechnological/biological products.
  • Janeway CAJ, Travers P, Walport M, Shlomchik MJ. 2005. Immunobiology. New York and London: Garland Science.
  • Kelley BD, Switzer M, Bastek P, Kramarczyk JF, Molnar K, Yu T, Coffman J. 2008. High-throughput screening of chromatographic separations: IV. Ion-exchange. Biotechnol Bioeng 100(5): 950963.
  • Krawitz DC, Forrest W, Moreno GT, Kittleson J, Champion KM. 2006. Proteomic studies support the use of multi-product immunoassays to monitor host cell protein impurities. Proteomics 6: 94110.
  • Lander ES, Linton LM, Birren B, et al. 2001. Initial sequencing and analysis of the human genome. Nature 409: 860921.
  • Lebreton B, Brown A, Reis RV. 2008. Application of High-performance tangential flow filtration (HPTFF) to the purification of a human pharmaceutical antibody fragment expressed in escherichia coli. Biotechnol Bioeng 100: 964974.
  • McKusick VA, Ruddle FH. 1987. A new discipline, a new name, a new journal. Genomics 1: 12.
  • Meager A. 2006. Measurement of cytokine by bioassays: Theory and applications. Methods 38: 237252.
  • Nick C. 2006. LascombeD, StonierPD, editors. Confronting the challenges in developing a biosimilar medicinal product, Haslemere, UK: Euromed Communications.
  • Ohmura T, Ohmizu A, Sumi A, Ohtani W, Uemura Y, Arimura H, Nishida M, Kohama Y, Okabe N, Mimura T, et al. 1987. Properties of recombinant Hepatitis B vaccine. Biochem Biophys Res Commun 149(3): 11721178.
  • Phillips M, Cormier J, Ferrence J, Dowd C, Kiss R, Lutz H, Carter J. 2005. Performance of a membrane adsorber for trace impurity removal in biotechnology manusfacturing. J Chromatogr A 1078: 7482.
  • Rammensee H-G, Bachmann J, Emmerich NPN, Bachor OA, Stevannvic S. 1999. SYFPEITHI: Database for MHC ligands and peptide motifs. Immunogenetics 50: 213219.
  • Rathore AS, Sobacke SE, Kocot TJ, Morgan DR, Dufield RL, Mozier NM. 2003. Analysis for residual host cell proteins and DNA in process streams of a recombinant protein product expressed in Escherichia coli cells. J Pharm Biomed Anal 32: 11991211.
  • Rinas U, Bailey JE. 1992. Protein compositional analysis of inclusion bodies produced in recombinant Escherichia coli. Appl Microbiol Biotechnol 37: 609614.
  • Rinas U, Boone TC, Bailey JE. 1993. Characterization of inclusion bodies in recombinant Escherichia coli producing high levels of porcine somatotropin. J Biotechnol 28: 313320.
  • Shukla AA, Hinckley P. 2008. Host cell protein clearance during protein a chromatography: Development of an improved column wash step. Biotechnol Prog 24: 11151121.
  • Shukla AA, Hubbard B, Tressel T, Guhan S, Low D. 2007. Downstream processing of monoclonal antibodies-Application of platform approaches. J Chromatogr B 848: 2839.
  • Shukla AA, Jiang C, Ma J, Rubacha M, Flansburg L, Lee SS. 2008. Demonstration of Robust host cell protein clearance in biopharmaceutical downstream processes. Biotechnol Prog 24: 615622.
  • Smales CM, Dinnis DM, Stansfield SH, Alete D, Sage EA, Birch JR, Racher AJ, Marshall CT, James DC. 2004. Comparative proteomic analysis of GS-NS0 murine myeloma cell line with varying recombinant monoclonal antibody production rate. Biotechnol Bioeng 88(4): 474488.
  • SpeicherDW, editor. 2008. Current protocols in protein science, Chapter 10, Section II. Electrophoretic separation of proteins. Hoboken, NJ: John Wiley and Sons. p. 10.2.110.5.1.
  • Thalhamer J, Freund J. 1984. Cascade immunization: A method of obtaining polyspecific antisera against crude fractions of antigens. J Immunol Methods 66: 245251.
  • Tobler SA, Noyes A, Rajewski JW, Shpritzer R, Piacenza W, Tannatt M, Coffman J, Vunnum S, Kelly B. 2006. Analysis of mAb protein A chromatograpgy peak precipitates and approaches to reduce peak turbidity. San Francisco, CA: American Chemical Society. p. 151.
  • Ullenhag G, Bird C, Ragnhammar P, Frodin JE, Strigard K, Osterborg A, Thorpe R, Mellstedt H, Wadhwa M. 2001. Incidence of GM-CSF antibodies in cancer patients receiving GM-CSF for immunostimulation. Clin Immunol 99(1): 6574.
  • Veeraragavan K. 1989. Studies on two major contaminating proteins of the cytoplasmic inclusion bodies in Escherichia coli. FEMS Microbiol Lett 61: 149152.
  • Venkiteshwaran A, Heider P, Matoservic S, Bogsnes A, Staby A, Sharfstein S, Belfort G. 2007. Optimized removal of soluble host cell proteins for the recovery of met-Human growth hormone inclusion bodies from Escherichia coli cell lysate using crossflow microfiltration. Biotechnol Prog 23: 667672.
  • Venter JC, Adams MD, et al. 2001. The sequence of the human genome. Science 291: 13041351.
  • Waterston RH, Lindblad-Toh K, Birney E, Rogers J, et al. 2002. Initial sequencing and comparative analysis of the mouse genome. Nature 420: 520562.
  • Weston AD, Hood L. 2004. System biology, proteomics, and the future of health care: Toward predictive, preventive, and personalized medicine. J Proteome Res 3(2): 179196.
  • Wilkins MR, Pasquali C, Appel RD, Ou K, Golaz O, Sanchez J-C, Yan JX, Gooley AA, Hughes G. 1996. From proteins to proteomes: Large scale protein identification by two-dimensional electrophoresis and amino acid analysis. Bio/Technology 14(1): 6165.
  • Zhu D, Saul AJ, Miles AP. 2005. A quantitative slot blot assay for host cell protein impurities in recombinant proteins expressed in E. coli. J Immunol Methods 306: 4050.