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BioanalysisVol. 3, No. 5 EditorialMS-based approaches for studying the pharmacokinetics of protein drugsCédric Mesmin, François Fenaille, Eric Ezan & François BecherCédric MesminCEA, iBiTec-S, Service de Pharmacologie et d'Immunoanalyse, 91191 Gif-sur-Yvette, France. , François FenailleCEA, iBiTec-S, Service de Pharmacologie et d'Immunoanalyse, 91191 Gif-sur-Yvette, France. , Eric EzanCEA, Ibeb, Biochemistry and Nuclear Toxicology Research Unit, Marcoule, France. & François Becher† Author for correspondenceCEA, iBiTec-S, Service de Pharmacologie et d'Immunoanalyse, 91191 Gif-sur-Yvette, France. Published Online:9 Mar 2011https://doi.org/10.4155/bio.11.21AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: biologicsbiotherapeuticsMSpharmacokineticsproteinBibliography1 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. Today16(1–2),58–64 (2010).Crossref, Medline, CAS, Google Scholar2 Ezan E, Dubois M, Becher F. Bioanalysis of recombinant proteins and antibodies by mass spectrometry. Analyst134(5),825–834 (2009).Crossref, Medline, CAS, Google Scholar3 Hoofnagle AN, Wener MH. The fundamental flaws of immunoassays and potential solutions using tandem mass spectrometry. J. Immunol. Methods347(1–2),3–11 (2009).Crossref, Medline, CAS, Google Scholar4 Vlieghe P, Lisowski V, Martinez J, Khrestchatisky M. Synthetic therapeutic peptides: science and market. Drug Discov. Today15(1–2),40–56 (2010).Crossref, Medline, CAS, Google Scholar5 van den Broek I, Sparidans RW,Schellens JH, Beijnen JH. Quantitative bioanalysis of peptides by liquid chromatography coupled to (tandem) mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.872(1–2),1–22 (2008).Crossref, Medline, CAS, Google Scholar6 Mesmin C, Dubois M, Becher F, Fenaille F, Ezan E. Liquid chromatography–tandem mass spectrometry assay for the absolute quantification of the expected circulating apelin peptides in human plasma. Rapid Commun. Mass Spectrom.24(19),2875–2884 (2010).Crossref, Medline, CAS, Google Scholar7 Murphy RE, Kinhikar AG, Shields MJ et al. Combined use of immunoassay and two-dimensional liquid chromatography–mass spectrometry for the detection and identification of metabolites from biotherapeutic pharmacokinetic samples. J. Pharm. Biomed. Anal.53(3),221–227 (2010).Crossref, Medline, CAS, Google Scholar8 Damen CW, Rosing H, Schellens JH, Beijnen JH. Quantitative aspects of the analysis of the monoclonal antibody trastuzumab using high-performance liquid chromatography coupled with electrospray mass spectrometry. J. Pharm. Biomed. Anal.46(3),449–455 (2008).Crossref, Medline, CAS, Google Scholar9 Campbell JL, Le Blanc JC. Targeted ion parking for the quantitation of biotherapeutic proteins: concepts and preliminary data. J. Am. Soc. Mass Spectrom.21(12),2011–2022 (2010).Crossref, Medline, CAS, Google Scholar10 Dupuis A, Hennekinne JA, Garin J, Brun V. Protein standard absolute quantification (PSAQ) for improved investigation of staphylococcal food poisoning outbreaks. Proteomics8(22),4633–4636 (2008).Crossref, Medline, CAS, Google Scholar11 Huang CJ, Lowe AJ, Batt CA. Recombinant immunotherapeutics: current state and perspectives regarding the feasibility and market. Appl. Microbiol. Biotechnol.87(2),401–410 (2010).Crossref, Medline, CAS, Google Scholar12 Yang Z, Ke J, Hayes M, Bryant M, Tse FL. A sensitive and high-throughput LC–MS/MS method for the quantification of PEGylated-interferon-α2a in human serum using monolithic C18 solid phase extraction for enrichment. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.877(18–19),1737–1742 (2009).Crossref, Medline, CAS, Google Scholar13 Chirino AJ, Ary ML, Marshall SA. Minimizing the immunogenicity of protein therapeutics. Drug Discov. Today9(2),82–90 (2004).Crossref, Medline, CAS, Google Scholar14 Ezan E, Bitsch F. Critical comparison of MS and immunoassays for the bioanalysis of therapeutic antibodies. Bioanalysis1(8),1375–1388 (2009).Link, CAS, Google Scholar15 Heinig K , Wirz T. Determination of taspoglutide in human and animal plasma using liquid chromatography–tandem mass spectrometry with orthogonal column-switching. Anal. Chem.81(10),3705–3713 (2009).Crossref, Medline, CAS, Google Scholar16 Ji QC, Rodila R, El-Shourbagy TA. A sample preparation process for LC–MS/MS analysis of total protein drug concentrations in monkey plasma samples with antibody. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.847(2),133–141 (2007).Crossref, Medline, CAS, Google Scholar17 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).Crossref, Medline, CAS, Google Scholar18 Neubert H, Grace C, Rumpel K, James I. Assessing immunogenicity in the presence of excess protein therapeutic using immunoprecipitation and quantitative mass spectrometry. Anal. Chem.80(18),6907–6914 (2008).Crossref, Medline, CAS, Google Scholar19 Prechel MM, Orawski AT, Maggiora LL, Simmons WH. Effect of a new aminopeptidase P inhibitor, apstatin, on bradykinin degradation in the rat lung. J. Pharmacol. Exp. Ther.275(3),1136–1142 (1995).Medline, CAS, Google Scholar20 Palazzuoli A, Antonelli G, Quatrini I, Nuti R. Natriuretic peptides in heart failure: where we are, where we are going. Intern. Emerg. Med.6(1),63–68 (2010).Crossref, Medline, Google Scholar21 Huang L, Lu J, Wroblewski VJ, Beals JM, Riggin RM. In vivo deamidation characterization of monoclonal antibody by LC–MS/MS. Anal. Chem.77(5),1432–1439 (2005).Crossref, Medline, CAS, Google Scholar22 van den Brock I, Sparidans RW, Huitema AD, Schellens JH, Beijnen JH. Development and validation of a quantitative assay for the measurement of two HIV-fusion inhibitors, enfuvirtide and tifuvirtide, and one metabolite of enfuvirtide (M-20) in human plasma by liquid chromatography–tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.837(1–2),49–58 (2006).Crossref, Medline, Google ScholarFiguresReferencesRelatedDetailsCited ByEnrichment of protein therapeutics and biomarkers for LC–MS quantificationJie Pu, Bo An, Faye Vazvaei & Jun Qu4 July 2018 | Bioanalysis, Vol. 10, No. 13LC–MS/MS strategies for therapeutic antibodies and investigation into the quantitative impact of antidrug-antibodiesMatthew Ewles, Ranbir Mannu, Chris Fox, Johannes Stanta, Graeme Evans, Lee Goodwin, James Duffy, Len Bell, Sian Estdale & David Firth25 November 2016 | Bioanalysis, Vol. 8, No. 24Quantitative MS analysis of therapeutic mAbs and their glycosylation for pharmacokinetics study10 December 2015 | PROTEOMICS - Clinical Applications, Vol. 10, No. 4Quantitation of a PEGylated protein in monkey serum by UHPLC-HRMS using a surrogate disulfide-containing peptide: A new approach to bioanalysis and in vivo stability evaluation of disulfide-rich protein therapeuticsAnalytica Chimica Acta, Vol. 916LC–MS/MS multiplexed assay for the 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Metrics Downloaded 975 times History Published online 9 March 2011 Published in print March 2011 Information© Future Science LtdKeywordsbiologicsbiotherapeuticsMSpharmacokineticsproteinFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.PDF download