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Research Article

A Workflow for Absolute Quantitation of Large Therapeutic Proteins in Biological Samples at Intact Level Using LC-HRMS

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Pages 1679-1691 | Received 14 Apr 2016, Accepted 13 Jun 2016, Published online: 20 Jul 2016

References

  • Van Den Broek I , NiessenWM, Van DongenWD. Bioanalytical LC–MS/MS of protein-based biopharmaceuticals. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 929, 161–179 (2013).
  • Zhang YJ , OlahTV, ZengJ. The integration of ligand binding and LC–MS-based assays into bioanalytical strategies for protein analysis. Bioanalysis6 (13), 1827–1841 (2014).
  • Jenkins R , DugganJX, AubryAFet al. Recommendations for validation of LC–MS/MS bioanalytical methods for protein biotherapeutics. AAPS J. 17 (1), 1–16 (2015).
  • Ciccimaro E , BlairIA. Stable-isotope dilution LC–MS for quantitative biomarker analysis. Bioanalysis2 (2), 311–341 (2010).
  • Li F , FastD, MichaelS. Absolute quantitation of protein therapeutics in biological matrices by enzymatic digestion and LC–MS. Bioanalysis3 (21), 2459–2480 (2011).
  • Liu G , JiQC, DodgeRet al. Liquid chromatography coupled with tandem mass spectrometry for the bioanalysis of proteins in drug development: practical considerations in assay development and validation. J. Chromatogr. A1284, 155–162 (2013).
  • An B , ZhangM, QuJ. Toward sensitive and accurate analysis of antibody biotherapeutics by liquid chromatography coupled with mass spectrometry. Drug Metab. Dispos. 42 (11), 1858–1866 (2014).
  • Cao J , Gonzalez-CovarrubiasV, StraubingerRMet al. A rapid, reproducible, on-the-fly orthogonal array optimization method for targeted protein quantification by LC/MS and its application for accurate and sensitive quantification of carbonyl reductases in human liver. Anal. Chem. 82 (7), 2680–2689 (2010).
  • Shuford CM , SederoffRR, ChiangVL, MuddimanDC. Peptide production and decay rates affect the quantitative accuracy of protein cleavage isotope dilution mass spectrometry (PC-IDMS). Mol. Cell. Proteomics11 (9), 814–823 (2012).
  • Van Den Broek I , RomijnFP, SmitNPet al. Quantifying protein measurands by peptide measurements: where do errors arise? J. Proteome Res . 14 (2), 928–942 (2015).
  • Ruan Q , JiQC, ArnoldME, HumphreysWG, ZhuM. Strategy and its implications of protein bioanalysis utilizing high-resolution mass spectrometric detection of intact protein. Anal. Chem. 83 (23), 8937–8944 (2011).
  • Zhang S , JianW. Recent advances in absolute quantification of peptides and proteins using LC–MS. Rev. Anal. Chem. 33 (1), 31–47 (2014).
  • Van Den Broek I , Van DongenWD. LC–MS-based quantification of intact proteins: perspective for clinical and bioanalytical applications. Bioanalysis7 (15), 1943–1958 (2015).
  • Jian W , EdomRW, WangD, WengN, ZhangSW. Relative quantitation of glycoisoforms of intact apolipoprotein C3 in human plasma by liquid chromatography-high-resolution mass spectrometry. Anal. Chem. 85 (5), 2867–2874 (2013).
  • Ji QC , RodilaR, GageEM, El-ShourbagyTA. A strategy of plasma protein quantitation by selective reaction monitoring of an intact protein. Anal. Chem. 75 (24), 7008–7014 (2003).
  • Bredehoft M , SchanzerW, ThevisM. Quantification of human insulin-like growth factor-1 and qualitative detection of its analogues in plasma using liquid chromatography/electrospray ionisation tandem mass spectrometry. Rapid Commun. Mass Spectrom. 22 (4), 477–485 (2008).
  • Ciccimaro E , RanasingheA, D’arienzoCet al. Strategy to improve the quantitative LC–MS analysis of molecular ions resistant to gas-phase collision induced dissociation: application to disulfide-rich cyclic peptides. Anal. Chem. 86 (23), 11523–11527 (2014).
  • 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).
  • Gucinski AC , BoyneMT, 2nd. Evaluation of intact mass spectrometry for the quantitative analysis of protein therapeutics. Anal. Chem. 84 (18), 8045–8051 (2012).
  • Zhang Z , PanH, ChenX. Mass spectrometry for structural characterization of therapeutic antibodies. Mass Spectrom. Rev. 28 (1), 147–176 (2009).
  • Xu K , LiuL, DereRet al. Characterization of the drug-to-antibody ratio distribution for antibody–drug conjugates in plasma/serum. Bioanalysis5 (9), 1057–1071 (2013).
  • Xu K , LiuL, SaadOMet al. Characterization of intact antibody–drug conjugates from plasma/serum in vivo by affinity capture capillary liquid chromatography-mass spectrometry. Anal. Biochem. 412 (1), 56–66 (2011).
  • Liu H , ManuilovAV, ChumsaeC, BabineauML, TarcsaE. Quantitation of a recombinant monoclonal antibody in monkey serum by liquid chromatography-mass spectrometry. Anal. Biochem. 414 (1), 147–153 (2011).
  • Ferrige AG , SeddonMJ, JarvisS, SkillingJ, AplinRA. Maximum entropy deconvolution in electrospray mass spectrometry. Rapid Commun. Mass Spectrom. 8, 374–377 (1991).
  • Ferrige AG , SeddonMJ, GreenBN, JarvisSA, SkillingJ, StauntonJ. Disentangling electrospray spectra with maximum entropy. Rapid Commun. Mass Spectrom. 6, 707–711 (1992).
  • Wu X , DenoyerL, TangN, SamantM, WaddellK. Enhanced and automated analysis for intact protein data by peak modeling charge deconvolution method for mass spectrometry. Presented at : The 60th ASMS Conference on Mass Spectrometry. Vancouver, Canada, 20–24 May 2012.
  • Sigma-Aldrich . Product information: SILu™Lite SigmaMAb universal antibody standard human. www.sigmaaldrich.com/catalog/product/sigma/msqc4.
  • Beck A , Sanglier-CianferaniS, Van DorsselaerA. Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry. Anal. Chem. 84 (11), 4637–4646 (2012).
  • 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. Chromatogr. 26 (8), 1024–1032 (2012).
  • Lee JW . Generic method approaches for monoclonal antibody therapeutics analysis using both ligand binding and LC–MS/MS techniques. Bioanalysis8 (1), 19–27 (2016).
  • Bronsema KJ , BischoffR, Van De MerbelNC. Internal standards in the quantitative determination of protein biopharmaceuticals using liquid chromatography coupled to mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 893-894, 1–14 (2012).
  • Wang Q , ZhangS, GuoLet al. Serum apolipoprotein A-1 quantification by LC–MS with a SILAC internal standard reveals reduced levels in smokers. Bioanalysis7 (22), 2895–2911 (2015).
  • Knutsson M , SchmidtR, TimmermanP. LC–MS/MS of large molecules in a regulated bioanalytical environment – which acceptance criteria to apply?Bioanalysis5 (18), 2211–2214 (2013).
  • Duggan JX , VazvaeiF, JenkinsR. Bioanalytical method validation considerations for LC–MS/MS assays of therapeutic proteins. Bioanalysis7 (11), 1389–1395 (2015).

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