752
Views
14
CrossRef citations to date
0
Altmetric
Report

Comparability analysis of protein therapeutics by bottom-up LC-MS with stable isotope-tagged reference standards

Pages 387-395 | Received 07 May 2011, Accepted 30 Apr 2011, Published online: 01 Jul 2011

References

  • US Food and Drug Administration. Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 2005; wwwfdagov/RegulatoryInformation/Guidances/ucm128059 htm
  • Woodcock J, Griffin J, Behrman R, Cherney B, Crescenzi T, Fraser B, et al. The FDA's assessment of follow-on protein products: a historical perspective. Nat Rev Drug Discov 2007; 6:437 - 442
  • Liu H, Gaza-Bulseco G, Faldu D, Chumsae C, Sun J. Heterogeneity of monoclonal antibodies. J Pharm Sci 2008; 97:2426 - 2447
  • Jenkins N, Meleady P, Tyther R, Murphy L. Strategies for analysing and improving the expression and quality of recombinant proteins made in mammalian cells. Biotechnol Appl Biochem 2009; 53:73 - 83
  • Jenkins N, Murphy L, Tyther R. Post-translational modifications of recombinant proteins: significance for biopharmaceuticals. Mol Biotechnol 2008; 39:113 - 118
  • Li H, d'Anjou M. Pharmacological significance of glycosylation in therapeutic proteins. Curr Opin Biotechnol 2009; 20:678 - 684
  • Tuli L, Ressom HW. LC-MS Based Detection of Differential Protein Expression. J Proteomics Bioinform 2009; 2:416 - 438
  • Griffin NM, Yu J, Long F, Oh P, Shore S, Li Y, et al. Label-free, normalized quantification of complex mass spectrometry data for proteomic analysis. Nat Biotechnol 2009; 28:83 - 89
  • Ong SE, Foster LJ, Mann M. Mass spectrometric-based approaches in quantitative proteomics. Methods 2003; 29:124 - 130
  • Beynon RJ, Pratt JM. Metabolic labeling of proteins for proteomics. Mol Cell Proteomics 2005; 4:857 - 872
  • Treumann A, Thiede B. Isobaric protein and peptide quantification: perspectives and issues. Expert Rev Proteomics 2010; 7:647 - 653
  • Gygi SP, Rist B, Gerber SA, Turecek F, Gelb MH, Aebersold R. Quantitative analysis of complex protein mixtures using isotope-coded affinity tags. Nat Biotechnol 1999; 17:994 - 999
  • Pratt JM, Simpson DM, Doherty MK, Rivers J, Gaskell SJ, Beynon RJ. Multiplexed absolute quantification for proteomics using concatenated signature peptides encoded by QconCAT genes. Nat Protoc 2006; 1:1029 - 1043
  • Kirkpatrick DS, Gerber SA, Gygi SP. The absolute quantification strategy: a general procedure for the quantification of proteins and post-translational modifications. Methods 2005; 35:265 - 273
  • Miyagi M, Rao KC. Proteolytic 18O-labeling strategies for quantitative proteomics. Mass Spectrom Rev 2007; 26:121 - 136
  • Heudi O, Barteau S, Zimmer D, Schmidt J, Bill K, Lehmann N, 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 2008; 80:4200 - 4207
  • Izrael-Tomasevic A, Phu L, Phung QT, Lill JR, Arnott D. Targeting interferon alpha subtypes in serum: a comparison of analytical approaches to the detection and quantitation of proteins in complex biological matrices. J Proteome Res 2009; 8:3132 - 3140
  • Brun V, Dupuis A, Adrait A, Marcellin M, Thomas D, Court M, et al. Isotope-labeled protein standards: toward absolute quantitative proteomics. Mol Cell Proteomics 2007; 6:2139 - 2149
  • Amini A, Nilsson E. Quantitative analysis of polypeptide pharmaceuticals by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. J Pharm Biomed Anal 2008; 46:411 - 417
  • Ye H, Hill J, Kauffman J, Han X. Qualitative and quantitative comparison of brand name and generic protein pharmaceuticals using isotope tags for relative and absolute quantification and matrix-assisted laser desorption/ionization tandem time-of-flight mass spectrometry. Anal Biochem 2010; 400:46 - 55
  • Ye H, Hill J, Kauffman J, Han X, Gryniewicz C. Detection of protein modifications and counterfeit protein pharmaceuticals using isotope tags for relative and absolute quantification and matrix-assisted laser desorption/ionization tandem time-of-flight mass spectrometry: studies of insulins. Anal Biochem 2008; 400:46 - 55
  • Wen D, Vecchi MM, Gu S, Su L, Dolnikova J, Huang YM, et al. Discovery and investigation of misincorporation of serine at asparagine positions in recombinant proteins expressed in Chinese hamster ovary cells. J Biol Chem 2009; 284:32686 - 32694
  • Yu XC, Borisov OV, Alvarez M, Michels DA, Wang YJ, Ling V. Identification of codon-specific serine to asparagine mistranslation in recombinant monoclonal antibodies by high-resolution mass spectrometry. Anal Chem 2009; 81:9282 - 9290
  • Geiger T, Wisniewski JR, Cox J, Zanivan S, Kruger M, Ishihama Y, et al. Use of stable isotope labeling by amino acids in cell culture as a spike-in standard in quantitative proteomics. Nat Protoc 2011; 6:147 - 157