354
Views
5
CrossRef citations to date
0
Altmetric
Research Article

LC–MS/MS Quantification of Next-Generation Biotherapeutics: A Case Study for an IgE Binding Nanobody in Cynomolgus Monkey Plasma

, , , , , , & show all
Pages 1201-1213 | Published online: 20 Jun 2014

References

  • Hamers-Casterman C , AtarhouchT, MuyldermansSet al. Naturally occurring antibodies devoid of light chains. Nature363 (6428), 446–448 (1993).
  • Van Bockstaele F , HolzJB, RevetsH. The development of nanobodies for therapeutic applications. Curr. Opin. Investig. Drugs10 (11), 1212–1224 (2009).
  • Lowe PJ , TannenbaumS, GautierA, JimenezP. Relationship between omalizumab pharmacokinetics, IgE pharmacodynamics and symptoms in patients with severe persistent allergic (IgE-mediated) asthma. Br. J. Clin. Pharmacol. 68 (1), 61–76 (2009).
  • Ezan E , BitschF. Critical comparison of MS and immunoassays for the bioanalysis of therapeutic antibodies. Bioanalysis1 (8), 1375–1388 (2009). 
  • Mesmin C , FenailleF, EzanE, BecherF. MS-based approaches for studying the pharmacokinetics of protein drugs. Bioanalysis3 (5), 477–480 (2011).
  • White JT , GolobM, SailstadJ. Understanding and mitigating impact of immunogenicity on pharmacokinetic assays. Bioanalysis3 (16), 1799–1803 (2011).
  • Fernandez Ocana M , JamesIT, KabirMet al. Clinical pharmacokinetic assessment of an anti-MAdCAM monoclonal antibody therapeutic by LC–MS/MS. Anal. Chem. 84 (14), 5959–5967 (2012). 
  • 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).
  • Pan S , AebersoldR, ChenRet al. Mass spectrometry based targeted protein quantification: methods and applications. J. Proteome Res. 8 (2), 787–797 (2009). 
  • Heudi O , BarteauS, ZimmerDet 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).
  • Fortin T , SalvadorA, CharrierJPet al. Multiple reaction monitoring cubed for protein quantification at the low nanogram/milliliter level in nondepleted human serum. Anal. Chem. 81 (22), 9343–9352 (2009).
  • Fortin T , SalvadorA, CharrierJPet al. Clinical quantitation of prostate-specific antigen biomarker in the low nanogram/milliliter range by conventional bore liquid chromatography-tandem mass spectrometry (multiple reaction monitoring) coupling and correlation with ELISA tests. Mol. Cell. Proteomics8 (5), 1006–1015 (2009).
  • Hagman C , RickeD, EwertS, BekS, FalchettoR, BitschF. Absolute quantification of monoclonal antibodies in biofluids by liquid chromatography-tandem mass spectrometry. Anal. Chem. 80 (4), 1290–1296 (2008).
  • Keshishian H , AddonaT, BurgessM, KuhnE, CarrSA. Quantitative, multiplexed assays for low abundance proteins in plasma by targeted mass spectrometry and stable isotope dilution. Mol. Cell. Proteomics6 (12), 2212–2229 (2007).
  • Li H , OrtizR, TranLet 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).
  • Lu Q , ZhengX, McintoshTet al. Development of different analysis platforms with LC–MS for pharmacokinetic studies of protein drugs. Anal. Chem. 81 (21), 8715–8723 (2009).
  • Neubert H , MuirheadD, KabirM, GraceC, CletonA, ArendsR. Sequential protein and peptide immunoaffinity capture for mass spectrometry-based quantification of total human beta-nerve growth factor. Anal. Chem. 85 (3), 1719–1726 (2013).
  • Razavi M , FrickLE, LamarrWAet al. High-throughput SISCAPA quantitation of peptides from human plasma digests by ultrafast, liquid chromatography-free mass spectrometry. J. Proteome Res. 11 (12), 5642–5649 (2012).
  • Yang Z , HayesM, FangX, DaleyMP, EttenbergS, TseFL. LC–MS/MS approach for quantification of therapeutic proteins in plasma using a protein internal standard and 2D-solid-phase extraction cleanup. Anal. Chem. 79 (24), 9294–9301 (2007).
  • European Medicine Agency. Guideline on Bioanalytical Method Validation. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf
  • 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). 
  • Anderson NL , AndersonNG. The human plasma proteome: history, character, and diagnostic prospects. Mol. Cell. Proteomics1 (11), 845–867 (2002).
  • Sandra K , MoshirM, D’hondtFet al. Highly efficient peptide separations in proteomics. Part 2: bi- and multidimensional liquid-based separation techniques. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 877 (11–12), 1019–1039 (2009). 

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.