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Volumn 6, Issue 23, 2014, Pages 3225-3235

Use of generic LC-MS/MS assays to characterize atypical PK profile of a biotherapeutic monoclonal antibody

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY MAB123; UNCLASSIFIED DRUG; LIGAND; MICROSPHERE;

EID: 84919807836     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.167     Document Type: Article
Times cited : (22)

References (40)
  • 1
    • 27144449009 scopus 로고    scopus 로고
    • Monoclonal antibody therapy of cancer
    • Adams GP, Weiner LM. Monoclonal antibody therapy of cancer. Nat. Biotech. 23(9), 1147-1157 (2005
    • (2005) Nat. Biotech , vol.23 , Issue.9 , pp. 1147-1157
    • Adams, G.P.1    Weiner, L.M.2
  • 3
    • 33644819090 scopus 로고    scopus 로고
    • Fully human therapeutic monoclonal antibodies
    • Weiner LM. Fully human therapeutic monoclonal antibodies. J. Immunother 29(1), 1-9 (2006
    • (2006) J. Immunother , vol.29 , Issue.1 , pp. 1-9
    • Weiner, L.M.1
  • 4
    • 0028220325 scopus 로고
    • Pharmacokinetics and tissue distribution of recombinant human transforming growth-factor beta(1) after topical and intravenous administration in male-rats
    • Zioncheck TF, Chen SA, Richardson L, et al. Pharmacokinetics and tissue distribution of recombinant human transforming growth-factor beta(1) after topical and intravenous administration in male-rats. Pharm. Res 11(2), 213-220 (1994
    • (1994) Pharm. Res , vol.11 , Issue.2 , pp. 213-220
    • Zioncheck, T.F.1    Chen, S.A.2    Richardson, L.3
  • 5
    • 10744230729 scopus 로고    scopus 로고
    • Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
    • Desilva B, Smith W, Weiner R, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20(11), 1885-1900 (2003
    • (2003) Pharm. Res , vol.20 , Issue.11 , pp. 1885-1900
    • Desilva, B.1    Smith Weiner W, R.2
  • 6
    • 79951980085 scopus 로고    scopus 로고
    • Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: Technical challenges and pk/pd applications over the course of drug development
    • Lee JW, Kelley M, King LE, et al. Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: Technical challenges and PK/PD applications over the course of drug development. AAPS J. 13(1), 99-110 (2011
    • (2011) AAPS J , vol.13 , Issue.1 , pp. 99-110
    • Lee, J.W.1    Kelley, M.2    King, L.E.3
  • 7
    • 84863012569 scopus 로고    scopus 로고
    • General lc-ms/ms method approach to quantify therapeutic monoclonal antibodies using a common whole antibody internal standard with application to preclinical studies
    • Li Hy, Ortiz R, Tran L, et al. General LC-MS/MS method approach to quantify therapeutic monoclonal antibodies using a common whole antibody internal standard with application to preclinical studies. Anal. Chem. 84(3), 1267-1273 (2012
    • (2012) Anal. Chem , vol.84 , Issue.3 , pp. 1267-1273
    • Li, H.Y.1    Ortiz, R.2    Tran, L.3
  • 8
    • 33645813378 scopus 로고    scopus 로고
    • Review - mass spectrometry and protein analysis
    • Domon B, Aebersold R. Review - mass spectrometry and protein analysis. Science 312(5771), 212-217 (2006
    • (2006) Science , vol.312 , Issue.5771 , pp. 212-217
    • Domon, B.1    Aebersold, R.2
  • 9
    • 84864010690 scopus 로고    scopus 로고
    • A universal surrogate peptide to enable lc-ms/ms bioanalysis of a diversity of human monoclonal antibody and human fc-fusion protein Drug candidates in pre-clinical animal studies
    • Furlong MT, Ouyang Z, Wu S, et al. A universal surrogate peptide to enable LC-MS/MS bioanalysis of a diversity of human monoclonal antibody and human Fc-fusion protein Drug candidates in pre-clinical animal studies. Biomed. Chromatogr. 26(8), 1024-1032
    • Biomed. Chromatogr , vol.26 , Issue.8 , pp. 1024-1032
    • Furlong, M.T.1    Ouyang, Z.2    Wu, S.3
  • 10
    • 44949213072 scopus 로고    scopus 로고
    • Towards absolute quantification of therapeutic monoclonal antibody in serum by lc-ms/ms using isotope-labeled antibody standard and protein cleavage isotope dilution mass spectrometry
    • Heudi O, Barteau S, Zimmer D, et al. Towards absolute quantification of therapeutic monoclonal antibody in serum by LC-MS/MS using isotope-labeled antibody standard and protein cleavage isotope dilution mass spectrometry. Anal. Chem. 80(11), 4200-4207 (2008
    • (2008) Anal. Chem , vol.80 , Issue.11 , pp. 4200-4207
    • Heudi, O.1    Barteau, S.2    Zimmer, D.3
  • 11
    • 39449087854 scopus 로고    scopus 로고
    • Absolute quantification of monoclonal antibodies in biofluids by liquid chromatographytandem mass spectrometry
    • Hagman C, Ricke D, Ewert S, et al. Absolute quantification of monoclonal antibodies in biofluids by liquid chromatographytandem mass spectrometry. Anal. Chem. 80(4), 1290-1296 (2008
    • (2008) Anal. Chem , vol.80 , Issue.4 , pp. 1290-1296
    • Hagman, C.1    Ricke, D.2    Ewert, S.3
  • 12
    • 70649105587 scopus 로고    scopus 로고
    • A universal strategy for development of a method for absolute quantification of therapeutic monoclonal antibodies in biological matrices using differential dimethyl labeling coupled with ultra-performance liquid chromatography-Tandem mass spectrometry
    • Ji CJ, Sadagopan N, Zhang YZ, Lepsy C. A universal strategy for development of a method for absolute quantification of therapeutic monoclonal antibodies in biological matrices using differential dimethyl labeling coupled with ultra-performance liquid chromatography-Tandem mass spectrometry. Anal. Chem. 81(22), 9321-9328 (2009
    • (2009) Anal. Chem , vol.81 , Issue.22 , pp. 9321-9328
    • Ji, C.J.1    Sadagopan, N.2    Zhang, Y.Z.3    Lepsy, C.4
  • 13
    • 37249028629 scopus 로고    scopus 로고
    • Lc-ms/ms approach therapeutic proteins for quantification of in plasma using a protein internal standard and 2d-solid-phase extraction cleanup
    • Yang ZP, Hayes M, Fang XP, et al. LC-MS/MS approach therapeutic proteins for quantification of in plasma using a protein internal standard and 2D-solid-phase extraction cleanup. Anal. Chem. 79(24), 9294-9301 (2007
    • (2007) Anal. Chem , vol.79 , Issue.24 , pp. 9294-9301
    • Yang, Z.P.1    Hayes, M.2    Fang, X.P.3
  • 14
    • 3142534409 scopus 로고    scopus 로고
    • Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
    • Mire-Sluis AR, Barrett Yc, devanarayan v, et al. recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289(1-2), 1-16 (2004
    • (2004) J. Immunol. Methods , vol.289 , Issue.1-2 , pp. 1-16
    • Mire-Sluis, A.R.1    Barrett, Y.C.2    Devanarayan, V.3
  • 15
    • 41349116947 scopus 로고    scopus 로고
    • Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products
    • Koren E, Smith HW, Shores E, et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J. Immunol. Methods 333(1-2), 1-9 (2008
    • (2008) J. Immunol. Methods , vol.333 , Issue.1-2 , pp. 1-9
    • Koren, E.1    Smith, H.W.2    Shores, E.3
  • 16
    • 58249116651 scopus 로고    scopus 로고
    • Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
    • Shankar G, Devanarayan V, Amaravadi L, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal. 48(5), 1267-1281 (2008
    • (2008) J. Pharm. Biomed. Anal , vol.48 , Issue.5 , pp. 1267-1281
    • Shankar, G.1    Devanarayan, V.2    Amaravadi, L.3
  • 17
    • 84856232988 scopus 로고    scopus 로고
    • Attribution of the discrepancy between elisa and lc-ms/ms assay results of a pegylated scaffold protein in post-dose monkey plasma samples due to the presence of anti-drug antibodies
    • Wang SJ, Wu ST, Gokemeijer J, et al. Attribution of the discrepancy between ELISA and LC-MS/MS assay results of a PEGylated scaffold protein in post-dose monkey plasma samples due to the presence of anti-drug antibodies. Anal. Biol. Chem. 402(3), 1229-1239 (2012
    • (2012) Anal. Biol. Chem , vol.402 , Issue.3 , pp. 1229-1239
    • Wang, S.J.1    Wu, S.T.2    Gokemeijer, J.3
  • 18
    • 84900333804 scopus 로고    scopus 로고
    • A white paper-consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements
    • Sailstad JM, Amaravadi L, Clements-Egan A, et al. A white paper-consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements. AAPS J. 1-11 (2014
    • (2014) AAPS J , pp. 1-11
    • Sailstad, J.M.1    Amaravadi, L.2    Clements-Egan, A.3
  • 19
    • 24644480554 scopus 로고    scopus 로고
    • Investigation of the immunogenicity of a protein Drug using equilibrium dialysis and liquid chromatography tandem mass spectrometry detection
    • Ji QC, Rodila R, Morgan SJ, et al. Investigation of the immunogenicity of a protein Drug using equilibrium dialysis and liquid chromatography tandem mass spectrometry detection. Anal. Chem. 77(17), 5529-5533 (2005
    • (2005) Anal. Chem , vol.77 , Issue.17 , pp. 5529-5533
    • Ji, Q.C.1    Rodila, R.2    Morgan, S.J.3
  • 20
    • 84879793348 scopus 로고    scopus 로고
    • Theoretical considerations and practical approaches to address the effect of anti-drug antibody ada on quantification of biotherapeutics in circulation
    • Kelley M, Ahene AB, Gorovits B, et al. Theoretical considerations and practical approaches to address the effect of anti-drug antibody (ADA) on quantification of biotherapeutics in circulation. AAPS J. 15(3), 646-658 (2013
    • (2013) AAPS J , vol.15 , Issue.3 , pp. 646-658
    • Kelley, M.1    Ahene, A.B.2    Gorovits, B.3
  • 21
    • 77953672945 scopus 로고    scopus 로고
    • Preparation of a highly specific polyclonal antibody against fluvastatin and its use in Development of elisa for determination of fluvastatin in plasma
    • Darwish IA, Al-Obaid ARM, Al-Malaq HAM. Preparation of a highly specific polyclonal antibody against fluvastatin and its use in Development of ELISA for determination of fluvastatin in plasma. Anal. Met. 1(3), 220-224 (2009
    • (2009) Anal. Met , vol.1 , Issue.3 , pp. 220-224
    • Darwish, I.A.1    Al-Obaid, A.R.M.2    Al-Malaq, H.A.M.3
  • 22
    • 77349117260 scopus 로고    scopus 로고
    • Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies
    • Stubenrauch K, Wessels U, Essig U, et al. Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies. J. Pharm. Biomed. Anal. 52(2), 249-254 (2010
    • (2010) J. Pharm. Biomed. Anal , vol.52 , Issue.2 , pp. 249-254
    • Stubenrauch, K.1    Wessels, U.2    Essig, U.3
  • 23
    • 84884353423 scopus 로고    scopus 로고
    • Comparison of bioanalytical methods for the quantitation of pegylated human insulin
    • De Dios K, Manibusan A, Marsden R, et al. Comparison of bioanalytical methods for the quantitation of PEGylated human insulin. J. Immunol. Methods 396(1-2), 1-7 (2013
    • (2013) J. Immunol. Methods , vol.396 , Issue.1-2 , pp. 1-7
    • De Dios, K.1    Manibusan, A.2    Marsden, R.3
  • 24
    • 14744268457 scopus 로고    scopus 로고
    • In vivo deamidation characterization of monoclonal antibody by lc/ms/ms
    • Huang LH, Li JR, Wroblewski VJ, et al. In vivo deamidation characterization of monoclonal antibody by LC/MS/MS. Anal. Chem. 77(5), 1432-1439 (2005
    • (2005) Anal. Chem , vol.77 , Issue.5 , pp. 1432-1439
    • Huang, L.H.1    Li, J.R.2    Wroblewski, V.J.3
  • 25
    • 20944441421 scopus 로고    scopus 로고
    • Characterization of a novel modification to monoclonal antibodies: Thioether cross-link of heavy and light chains
    • Tous GI, Wei ZP, Feng JH, et al. Characterization of a novel modification to monoclonal antibodies: Thioether cross-link of heavy and light chains. Anal. Chem. 77(9), 2675-2682 (2005
    • (2005) Anal. Chem , vol.77 , Issue.9 , pp. 2675-2682
    • Tous, G.I.1    Wei, Z.P.2    Feng, J.H.3
  • 26
    • 0033621537 scopus 로고    scopus 로고
    • Mass spectrometry - from genomics to proteomics
    • Yates JR. Mass spectrometry - from genomics to proteomics. Trends Genet. 16(1), 5-8 (2000
    • (2000) Trends Genet , vol.16 , Issue.1 , pp. 5-8
    • Yates, J.R.1
  • 27
    • 54049090766 scopus 로고    scopus 로고
    • Selected reaction monitoring for quantitative proteomics: A tutorial
    • Lange V, Picotti P, Domon B, Aebersold R. Selected reaction monitoring for quantitative proteomics: A tutorial. Mol. Syst. Biol. 4, 222 (2008
    • (2008) Mol. Syst. Biol , vol.4 , pp. 222
    • Lange, V.1    Picotti, P.2    Domon, B.3    Aebersold, R.4
  • 28
    • 77954464041 scopus 로고    scopus 로고
    • Proteomics: A pragmatic perspective
    • Mallick P, Kuster B. Proteomics: A pragmatic perspective. Nat. Biotech. 28(7), 695-709 (2010
    • (2010) Nat. Biotech , vol.28 , Issue.7 , pp. 695-709
    • Mallick, P.1    Kuster, B.2
  • 29
    • 77954523086 scopus 로고    scopus 로고
    • Options and considerations when selecting a quantitative proteomics strategy
    • Domon B, Aebersold R. Options and considerations when selecting a quantitative proteomics strategy. Nat. Biotech. 28(7), 710-721 (2010
    • (2010) Nat. Biotech , vol.28 , Issue.7 , pp. 710-721
    • Domon, B.1    Aebersold, R.2
  • 30
    • 79953227740 scopus 로고    scopus 로고
    • Increased selectivity, analytical precision, and throughput in targeted proteomics
    • Kiyonami R, Schoen A, Prakash A, et al. Increased selectivity, analytical precision, and throughput in targeted proteomics. Mol. Cell. Proteomics 10(2), M110002931 (2011
    • (2011) Mol. Cell. Proteomics , vol.10 , Issue.2 , pp. M110002931
    • Kiyonami, R.1    Schoen, A.2    Prakash, A.3
  • 31
    • 0036767470 scopus 로고    scopus 로고
    • Targeted proteomics of low-level proteins in human plasma by lc/msn: Using human growth hormone as a model system
    • Wu SL, Amato H, Biringer R, et al. Targeted proteomics of low-level proteins in human plasma by LC/MSn: Using human growth hormone as a model system. J. Proteome Res. 1(5), 459-465 (2002
    • (2002) J. Proteome Res , vol.1 , Issue.5 , pp. 459-465
    • Wu, S.L.1    Amato, H.2    Biringer, R.3
  • 32
    • 17244383269 scopus 로고    scopus 로고
    • 2d-lc/ms techniques for the identification of proteins in highly complex mixtures
    • Nagele E, Vollmer M, Horth P, et al. 2D-LC/MS techniques for the identification of proteins in highly complex mixtures. Expert Rev. Proteomics 1(1), 37-46 (2004
    • (2004) Expert Rev. Proteomics , vol.1 , Issue.1 , pp. 37-46
    • Nagele, E.1    Vollmer, M.2    Horth, P.3
  • 33
    • 13844271208 scopus 로고    scopus 로고
    • Protein identification using 2d-lc-ms/ms
    • Delahunty C, Yates JR. Protein Identification Using 2D-LC-MS/MS. Methods 35(3), 248-255 (2005
    • (2005) Methods , vol.35 , Issue.3 , pp. 248-255
    • Delahunty, C.1    Yates, J.R.2
  • 34
    • 14844313671 scopus 로고    scopus 로고
    • Matrix effects: The achilles heel of quantitative high-performance liquid chromatography-electrospraytandem mass spectrometry
    • Taylor PJ. Matrix effects: The Achilles heel of quantitative high-performance liquid chromatography-electrospraytandem mass spectrometry. Clin. Biochem. 38(4), 328-334 (2005
    • (2005) Clin. Biochem , vol.38 , Issue.4 , pp. 328-334
    • Taylor, P.J.1
  • 35
    • 33645721632 scopus 로고    scopus 로고
    • Quantitative mass spectrometric multiple reaction monitoring assays for major plasma proteins
    • Anderson L, Hunter CL. Quantitative mass spectrometric multiple reaction monitoring assays for major plasma proteins. Mol. Cell. Proteomics 5(4), 573-588 (2006
    • (2006) Mol. Cell. Proteomics , vol.5 , Issue.4 , pp. 573-588
    • Anderson, L.1    Hunter, C.L.2
  • 36
    • 77955608229 scopus 로고    scopus 로고
    • Immunoaffinity purification using anti-peg antibody followed by two-dimensional liquid chromatography/tandem mass spectrometry for the quantification of a pegylated therapeutic peptide in human plasma
    • Xu Y, Mehl JT, Bakhtiar R, et al. Immunoaffinity purification using anti-PEG antibody followed by two-dimensional liquid chromatography/tandem mass spectrometry for the quantification of a PEGylated therapeutic peptide in human plasma. Anal. Chem. 82(16), 6877-6886 (2010
    • (2010) Anal. Chem , vol.82 , Issue.16 , pp. 6877-6886
    • Xu, Y.1    Mehl, J.T.2    Bakhtiar, R.3
  • 37
    • 34247116419 scopus 로고    scopus 로고
    • Coupling immunoaffinity techniques with ms for quantitative analysis of lowabundance protein biomarkers
    • Ackermann BL, Berna MJ. Coupling immunoaffinity techniques with MS for quantitative analysis of lowabundance protein biomarkers. Expert Rev. Proteomics 4(2), 175-186 (2007
    • (2007) Expert Rev. Proteomics , vol.4 , Issue.2 , pp. 175-186
    • Ackermann, B.L.1    Berna, M.J.2
  • 38
    • 84885004683 scopus 로고    scopus 로고
    • LC-MS/MS of large molecules in a regulated bioanalytical environment - Which acceptance criteria to apply?
    • Knutsson M, Schmidt R, Timmerman P. LC-MS/MS of large molecules in a regulated bioanalytical environment - which acceptance criteria to apply? Bioanalysis 5(18), 2211-2214 (2013
    • (2013) Bioanalysis , vol.5 , Issue.18 , pp. 2211-2214
    • Knutsson, M.1    Schmidt, R.2    Timmerman, P.3
  • 39
    • 84869840045 scopus 로고    scopus 로고
    • A strategy for risk mitigation of antibodies with fast clearance
    • Hotzel I, Theil FP, Bernstein LJ, et al. A strategy for risk mitigation of antibodies with fast clearance. MAbs 4(6), 753-760 (2012
    • (2012) MAbs , vol.4 , Issue.6 , pp. 753-760
    • Hotzel, I.1    Theil, F.P.2    Bernstein, L.J.3
  • 40
    • 78651400009 scopus 로고    scopus 로고
    • Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data
    • Deng R, Iyer S, Theil FP, et al. Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data. What have we learned? MAbs 3(1), 61-66 (2011
    • (2011) What Have We Learned? MAbs , vol.3 , Issue.1 , pp. 61-66
    • Deng, R.1    Iyer, S.2    Theil, F.P.3


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