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Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online two-dimensional liquid chromatography/mass spectrometry

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Pages 24-44 | Received 15 Sep 2011, Accepted 11 Nov 2011, Published online: 01 Jan 2012

References

  • ICH Harmonised Tripartite Guideline. Specifications: Test procedures and acceptance criteria for biotechnological/biological products Q6B 1999;
  • European Medicines Agency. Omnitrope: Scientific Discussion 2006 http://www.emea.europa.eu/humandocs/PDFs/EPAR/Omnitrope/060706en6.pdf
  • European Medicines Agency. Alpheon: Scientific Discussion 2006 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/000585/WC500017451.pdf
  • Schellekens H. Biosimilar therapeutics—what do we need to consider?. NDT Plus 2009; 2:27 - 36; http://dx.doi.org/10.1093/ndtplus/sfn177
  • Hoffman K. Strategies for host cell protein analysis. Biopharm 2000; 13:38 - 45
  • Champion K, Madden H, Dougherty J, Shacter E. Defining your product profile and maintaining control over it, Part 2: Challenges of monitoring host cell protein impurities. BioProcess Intl 2005; 3:52 - 57
  • Wang X, Hunter AK, Mozier NM. Host cell proteins in biologics development: identification, quantitation and risk assessment. Biotechnol Bioeng 2009; 103:446 - 458; PMID: 19388135; http://dx.doi.org/10.1002/bit.22304
  • Rathore AS, Sobacke SE, Kocot TJ, Morgan DR, Dufield RL, Mozier NM. 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 2003; 32:1199 - 1211; PMID: 12907264; http://dx.doi.org/10.1016/S0731-7085(03)00157-2
  • Wang X, Schomogy T, Wells K, Mozier NM. Improved HCP quantitation by minimizing antibody cross-reactivity to target proteins. BioProcess Intl 2010; 8:18 - 23
  • Savino E, Hu B, Sellers J, Sobjak A, Majewski N, Fenton S, et al. Development of an in-house, process-specific ELISA for detecting HCP in a therapeutic antibody, Part 1. BioProcess Intl 2011; 9:38 - 47
  • Savino E, Hu B, Sellers J, Sobjak A, Majewski N, Fenton S, et al. Development of an in-house, process-specific ELISA for detecting HCP in a therapeutic antibody, Part 2. BioProcess Intl 2011; 9:68 - 77
  • Hayduk EJ, Choe LH, Lee KH. A two-dimensional electrophoresis map of Chinese hamster ovary cell proteins based on fluorescence staining. Electrophoresis 2004; 25:2545 - 2556; PMID: 15300775; http://dx.doi.org/10.1002/elps.200406010
  • Jin M, Szapiel N, Zhang J, Hickey J, Ghose S. Profiling of host cell proteins by two-dimensional difference gel electrophoresis (2D-DIGE): Implications for downstream process development. Biotechnol Bioeng 2010; 105:306 - 316; PMID: 19739084; http://dx.doi.org/10.1002/bit.22532
  • Srebalus Barnes CA, Lim A. Applications of mass spectrometry for the structural characterization of recombinant protein pharmaceuticals. Mass Spectrom Rev 2007; 26:370 - 388; PMID: 17410555; http://dx.doi.org/10.1002/mas.20129
  • Chen G, Pramanik BH. LC-MS for protein characterization: Current capabilities and future trends. Expert Rev Proteomics 2008; 5:435 - 444; PMID: 18532911; http://dx.doi.org/10.1586/14789450.5.3.435
  • Chen G, Warrack BM, Goodenough AK, Wei H, Wang-Iverson DB, Tymiak AA. Characterization of protein therapeutics by mass spectrometry: Recent developments and future directions. Drug Discov Today 2011; 16:58 - 64; PMID: 21093608; http://dx.doi.org/10.1016/j.drudis.2010.11.003
  • Gross ML, Chen G, Pramanik BN. Protein and peptide mass spectrometry in drug discovery 2011; Hoboken, NJ USA John Wiley and Sons, Inc
  • Dowling P, Meleady P, Henry M, Clynes P. Recent advances in clinical proteomics using mass spectrometry. Bioanalysis 2010; 2:1609 - 1615; PMID: 21083289; http://dx.doi.org/10.4155/bio.10.69
  • Chen G, Pramanik BN. Application of LC/MS to proteomics studies: Current status and future prospects. Drug Discov Today 2009; 14:465 - 471; PMID: 19429505; http://dx.doi.org/10.1016/j.drudis.2009.02.007
  • Antonioli P, Fortis F, Guerrier L, Rinalducci S, Zolla L, Righetti PG, et al. Capturing and amplifying impurities from purified recombinant monoclonal antibodies via peptide library beads: A proteomic study. Proteomics 2007; 7:1624 - 1633; PMID: 17436265; http://dx.doi.org/10.1002/pmic.200600778
  • Hunter AK, Wang X, Suda EJ, Herber JT, Shell RE, Thomas KE, et al. Separation of product associating E. coli host cell proteins OppA and DppA from recombinant apolipoprotein A-I in an industrial HIC unit operation. Biotechnol Prog 2009; 25:446 - 453; PMID: 19291803; http://dx.doi.org/10.1002/btpr.106
  • Wierling PS, Bogumil R, Grunhagen EK, Hubbuck J. High-throughput screening of packed-bed chromatography coupled with SELDI-TOF MS analysis: monoclonal antibodies versus host cell protein. Biotechnol Bioeng 2007; 98:440 - 450; PMID: 17335062; http://dx.doi.org/10.1002/bit.21399
  • Fortis F, Guerrier L, Areces LB, Antonioli P, Hayes T, Carrick K, et al. A new approach for the detection and identification of protein impurities using combinatorial solid phase ligand libraries. J Proteome Res 2006; 5:2577 - 2585; PMID: 17022629; http://dx.doi.org/10.1021/pr060090s
  • Snyder L, Kirkland J, Dolan J. Basic concepts and the control of separation in: Introduction to modern liquid chromatography 2010; 3:Hoboken, NJ USA John Wiley & Sons 73
  • Washburn MP, Wolters DA, Yates JR III. Large-scale analysis of the yeast proteome by multidimensional protein identification technology. Nat Biotechnol 2001; 19:242 - 247; PMID: 11231557; http://dx.doi.org/10.1038/85686
  • Gilar M, Olivova P, Daly AE, Gebler JC. Orthogonality in separation in two-dimensional liquid chromatography. Anal Chem 2005; 77:6426 - 6434; PMID: 16194109; http://dx.doi.org/10.1021/ac050923i
  • Gilar M, Olivova P, Daly AE, Gebler JC. Two-dimensional separation of peptides using a RP-RP-HPLC system with different pH in the first and second separation dimensions. J Sep Sci 2005; 28:1694 - 1703; PMID: 16224963; http://dx.doi.org/10.1002/jssc.200500116
  • Toll H, Oberacher H, Swart R, Huber C. Separation, detection and identification of peptides by ion-pair reversed-phase high-performance liquid chromatography-electrospray ionization mass spectrometry at high and low pH. J Chromatogr A 2005; 1079:274 - 286; PMID: 16038314; http://dx.doi.org/10.1016/j.chroma.2005.03.121
  • Dowell JA, Frost DC, Zhang J, Li L. Comparison of two-dimensional fractionation techniques for shutgon proteomics. Anal Chem 2008; 80:6715 - 6723; PMID: 18680313; http://dx.doi.org/10.1021/ac8007994
  • Delmotte N, Lasaosa M, Tholey A, Heinzle E, Huber CG. Two-dimensional reversed-phase x ion-pair reversed-phase HPLC: An alternative approach to high-resolution peptide separation for shotgun proteome analysis. J Proteome Res 2007; 6:4363 - 4373; PMID: 17924683; http://dx.doi.org/10.1021/pr070424t
  • Nakamura T, Kuromitsu J, Oda Y. Evaluation of comprehensive multidimensional separations using reversed-phase, reversed-phase liquid chromatography/mass spectrometry for shotgun proteomics. J Proteome Res 2008; 7:1007 - 1011; PMID: 18247544; http://dx.doi.org/10.1021/pr7005878
  • Gilar M, Olivova P, Chakrabory A, Jaworski A, Geromanos S, Gebler JC. Comparison of 1-D and 2-D LC MS/MS methods for proteomic analysis of human serum. Electrophoresis 2009; 30:1157 - 1167; PMID: 19283699; http://dx.doi.org/10.1002/elps.200800630
  • Song C, Ye M, Han G, Jiang X, Wang F, Yu Z, et al. Reversed-phase-reversed-phase liquid chromatography approach with high orthogonality for multidimensional separation of phosphopeptides. Anal Chem 2010; 82:53 - 56; PMID: 19950968; http://dx.doi.org/10.1021/ac9023044
  • Calipo L, Capriotti SL, Cavaliere C, Gubbioti R, Samperi R, Lagana A. Evaluation of different two-dimensional chromatographic techniques for proteomic analysis of mouse cardiac tissue. Biomed Chrom 2010; 5:594 - 599
  • Zhou F, Cardozza JD, Ficarro SB, Adelmant G, Lazaro JB, Marto J. Online nanoflow RP-RP-MS reveals dynamics of multicomponent Ku complex in response to DNA damage. J Proteome Res 2010; 9:6242 - 6255; PMID: 20873769; http://dx.doi.org/10.1021/pr1004696
  • Wang Y, Yang F, Gritsenko M, Wang Y, Clauss T, Liu T, et al. Reversed-phase chromatography with multiple fraction concatenation strategy for proteome profiling of human MCF10A cells. Proteomics 2011; 11:2019 - 2026; PMID: 21500348; http://dx.doi.org/10.1002/pmic.201000722
  • Stapels M, Fadgen K. A reproducible online 2D reversed phase-reversed phase high-low pH method for qualitative and quantitative proteomics. Curr Trends Mass Spectrom 2009; 14 - 15
  • Donato P, Cacciola F, Sommella E, Fanali C, Dugo L, Dacha M, et al. Online comprehensive RPLC × RPLC with mass spectrometry detection for the analysis of proteomce samples. Anal Chem 2011; 83:2485 - 2491; PMID: 21384902; http://dx.doi.org/10.1021/ac102656b
  • François I, Cabooter D, Sandra K, Lynen F, Desmet G, Sandra P. Tryptic digest analysis by comprehensive reversed phase x two reversed phase chromatography (RP-LC × 2RP-LC) at different pHs. J Sep Sci 2009; 32:1137 - 1144; PMID: 19360782; http://dx.doi.org/10.1002/jssc.200800578
  • Griffiths SW, Cooney C. Development of a peptide mapping procedure to identify and quantify methionine oxidation in recombinant human alpha1-antitrypsin. J Chromatogr A 2002; 942:133 - 143; PMID: 11822379; http://dx.doi.org/10.1016/S0021-9673(01)01350-4
  • Xie H, Gilar M. Improving LC peak shape of proline-rich peptides within an antibody peptide map. Waters Application 720003063en 2009;
  • Silva J, Gorenstein M, Li GJ, Vissers P, Geromanos S. Absolute quantification of proteins by LCMSE: A virtue of parallel MS acquisition. Mol Cell Proteomics 2006; 1:144 - 156
  • Silva JC, Denny R, Dorschel C, Gorenstein M, Li G, Richardson K, et al. Simultaneous qualitative and quantitative analysis of the Escherichia coli proteome: a sweet tale. Mol Cell Proteomics 2006; 5:589 - 607; PMID: 16399765; http://dx.doi.org/10.1074/mcp.M500321-MCP200
  • Bateman RH, Carruthers R, Hoyes J, Jones C, Langridge J, Millar A, et al. A novel precursor ion discovery method on a hybrid quadrupole orthogonal acceleration time-of-flight (Q-TOF) mass spectrometer for studying protein phosphorylation. J Am Soc Mass Spectrom 2002; 13:792 - 803; PMID: 12148804; http://dx.doi.org/10.1016/S1044-0305(02)00420-8
  • Purvine S, Eppel J, Yi E, Goodlett D. Shotgun collision-induced dissociation of peptides using a time of flight mass analyzer. Proteomics 2003; 3:847 - 850; PMID: 12833507; http://dx.doi.org/10.1002/pmic.200300362
  • Silva JC, Denny R, Dorschel A, Gorenstein M, Kass I, Li GJ. Quantitative proteomic analysis by accurate mass retention time pairs. Anal Chem 2005; 77:2187 - 2200; PMID: 15801753; http://dx.doi.org/10.1021/ac048455k
  • Xu X, Nagarajan H, Lewis NE, Pan S, Cai Z, Liu X, et al. The genomic sequence of the chinese hamster ovary (CHO)-K1 cell line. Nat Biotechnol 2011; 29:735 - 741; PMID: 21804562; http://dx.doi.org/10.1038/nbt.1932
  • Carlage T, Hincapie M, Zang L, Lyubarskaya E, Madden H, Mhatre R, et al. Proteomic profiling of a high-producing chinese hamster ovary cell line. Anal Chem 2009; 81:7357 - 7362; PMID: 19663468; http://dx.doi.org/10.1021/ac900792z
  • Kuystermans D, Dunn M, Al-Rubeai M. A proteomic study of cMyc improvement of CHO culture. BMC Biotechnol 2010; 10:1 - 13; PMID: 20074328; http://dx.doi.org/10.1186/1472-6750-10-25
  • Maclean B, Tomazela D, Abbatiello S, Zhang S, Whiteaker J, Paulovich M, et al. Effect of collision energy optimization on the measurements of peptides by selected reaction monitoring (SRM) mass spectrometry. Anal Chem 2010; 82:10116 - 10124; PMID: 21090646; http://dx.doi.org/10.1021/ac102179j
  • Geromanos SJ, Vissers J, Silva J, Dorschel C, Li GZ, Gorenstein M, et al. The detection, correlation and comparison of peptide precursors and product ions from data independent LC-MS with data dependent LC-MS/MS. Proteomics 2009; 9:1683 - 1695; PMID: 19294628; http://dx.doi.org/10.1002/pmic.200800562
  • Li GZ, Vissers J, Silva J, Golick D, Gorenstein M, Geromanos SJ. Database searching and accounting of multiplexed precursor and product ion spectra from the data independent analysis of simple and complex peptide mictures. Proteomics 2009; 9:1696 - 1719; PMID: 19294629; http://dx.doi.org/10.1002/pmic.200800564