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Research Article

Application of High-Resolution MS in The Quantification of A Therapeutic Monoclonal Antibody in Human Plasma

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Pages 1767-1779 | Published online: 26 Aug 2014

References

  • Beck A , WurchT, BaileyC, CorvaiaN. Strategies and challenges for the next generation of therapeutic antibodies. Nat. Rev. Immunol. 10 (5), 345–352 (2010).
  • Nelson AL , DhimoleaE, ReichertJM. Development trends for human monoclonal antibody therapeutics. Nat. Rev. Drug Discov. 9 (10), 767–774 (2010).
  • DeSilva B , SmithW, WeinerR, KelleyMet al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20 (11), 1885–1900 (2003).
  • Damen CW , de GrootER, HeijMet al. Development and validation of an enzyme-linked immunosorbent assay for the quantification of trastuzumab in human serum and plasma. Anal. Biochem. 391, 114–120 (2009).
  • Hoofnagle AN , WenerMH. The fundamental flaws of immunoassays and potential solutions using tandem mass spectrometry. Immunol. Methods347 (1–2), 3–11 (2009).
  • Ezan E , BitschF. Critical comparison of MS and immunoassays for the bioanalysis of therapeutic antibodies. Bioanalysis1 (8), 1375–1388 (2009).
  • Li F , FastD, MichaelS. Absolute quantitation of protein therapeutics in biological matrices by enzymatic digestion and LC–MS. Bioanalysis3 (21), 2459–2480 (2011).
  • Mesmin C , FenailleF, EzanE, BecherF. MS-based approaches for studying the pharmacokinetics of protein drugs. Bioanalysis3 (5), 477–480 (2011).
  • Ezan E , DuboisM, BecherF. Bioanalysis of recombinant proteins and antibodies by mass spectrometry. Analyst134 (5), 825–834 (2009).
  • Ewles M , GoodwinL. Bioanalytical approaches to analyzing peptides and proteins by LC–MS/MS. Bioanalysis3 (12), 1379–1397 (2011).
  • van den Broek I , NiessenWMA, van DongenWD. Bioanalytical LC–MS/MS of protein-based biopharmaceuticals. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 15 (929), 161–179 (2013).
  • Furlong MT , OuyangZ, WuSet 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. Chrom. 26 (8), 1024–1032 (2012).
  • Furlong MT , ZhaoS, MylottW, JenkinsR, GaoMet al. Dual universal peptide approach to bioanalysis of human monoclonal antibody protein drug candidates in animal studies. Bioanalysis5 (11), 1363–1376 (2013).
  • Morin LP , MessJN, GarofoloF. Large-molecule quantification: sensitivity and selectivity head-to-head comparison of triple quadrupole with Q-TOF. Bioanalysis5 (10), 1181–1193 (2013).
  • Dillen Lieve , CoolsW, VereykenL, LorreyneWet al. Comparison of triple quadrupole and high-resolution TOF-MS for quantification of peptides. Bioanalysis4 (5), 565–579 (2012).
  • Huang MQ , LinZ, WengN. Applications of high-resolution MS in bioanalysis. Bioanalysis5 (10), 1269–1276 (2013).
  • Ramagiri S , GarofoloF. Large molecule bioanalysis using Q-TOF without predigestion and its data processing challenges. Bioanalysis4 (5), 529–540 (2012).
  • Liu H , ManuilovAV, ChumsaeC, BabineauML, TarcsaE. Quantitation of a recombinant monoclonal antibody in monkey serum by liquid chromatography-mass spectrometry. Anal. Biochem. 414, 147–153 (2011).
  • Reff ME , CarnerK, ChambersKS, ChinnPCet al. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody. Blood83, 2861–2868 (1994).
  • Du J , WangH, ZhongC, PengB, ZhangMet al. Crystal structure of chimeric antibody C2H7 Fab in complex with a CD20 peptide. Mol. Immunol. 45, 2861–2868 (2008).
  • Mok CC . Rituximab for the treatment of rheumatoid arthritis: an update. Drug Des. Devel. Ther. 8, 87–100 (2014).
  • Samonig M , HuberC, SchefflerK. LC/MS analysis of the monoclonal antibody Rituximab using Q Exactive benchtop Orbitrap mass spectrometer. Thermo Scientific, Application note 591 : www.planetorbitrap.com
  • Bronsema KJ , BischoffR, vande Merbel NC. Internal standards in the quantitative determination of protein biopharmaceuticals using liquid chromatography coupled to mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 15, 893–894 (2012).
  • Heudi O , BarteauS, ZimmerD, SchmidtJet 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).
  • Li H , OrtizR, TranL, HallM, SpahrC, WalkerKet 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, 1267–1273 (2012).
  • Ocaña MF , NeubertH. An immunoaffinity liquid chromatography-tandem mass spectrometry assay for the quantitation of matrix metalloproteinase 9 in mouse serum. Anal. Biochem. 399, 202–210 (2010).
  • Neubert H , MuirheadD, KabirM, GraceCet al. Sequential protein and peptide immunoaffinity capture for mass spectrometry-based quantification of total human β-nerve growth factor. Anal. Chem. 85 (3), 1719–1726 (2013).
  • Ouyang Z , FurlongMT, WuSet al. Pellet digestion: a simple and efficient sample preparation technique for LC–MS/MS quantification of large therapeutic proteins in plasma. Bioanalysis4 (1), 17–28 (2012).
  • Yuan L , ArnoldME, AubryA-F, JiQC. Simple and efficient digestion of a monoclonal antibody in serum using pellet digestion: comparison with traditional digestion methods in LC–MS/MS bioanalysis. Bioanalysis4 (24), 2887–2896 (2012).
  • Yu YQ , GilarM, LeePJ, BouvierES, GeblerJC. Enzyme-friendly, mass spectrometry-compatible surfactant for in-solution enzymatic digestion of proteins. Anal. Chem. 75, 6023–6028 (2003).
  • Chen EI , CociorvaD, NorrisJL, YatesJRIII.. Optimization of mass spectrometry compatible surfactants for shotgun proteomics. J. Proteome Res. 6 (7), 2529–2538 (2007).
  • Proc JL , KuzykMA, HardieDB, YangJet al. A qualitative study of the effects of chaotropic agents, surfactants, and solvents on the digestion efficiency of human plasma proteins by trypsin. J. Proteome Res. 9 (10), 5422–5437 (2010).
  • Mitulovic G , StinglC, SteinmacherI, HudeczOet al. Preventing carryover of peptides and proteins in nano LC–MS separations. Anal. Chem. 14, 5955–5960 (2009).
  • Chambers EE , LameME, BardsleyJ, HannamSet al. High sensitivity LC–MS/MS method for direct quantification of human parathyroid 1–34 (teriparatide) in human plasma. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 938, 96–104 (2013).

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