Establishment of a highly precise multi-attribute method for the characterization and quality control of therapeutic monoclonal antibodies

References

• Kaplon H, Muralidharan M, Schneider Z, et al. Antibodies to watch in 2020. MAbs. 2020;12:1703531.
   PubMed Web of Science ®Google Scholar
• Sakanaka C. Antibody therapeutics: bench to bedside. Yakugaku Zasshi. 2017;137:817–822.
   PubMed Web of Science ®Google Scholar
• Grilo AL, Mantalaris A. The increasingly human and profitable monoclonal antibody market. Trends Biotechnol. 2019;37:9–16.
   PubMed Web of Science ®Google Scholar
• Brinkmann U, Kontermann RE. The making of bispecific antibodies. MAbs. 2017;9:182–212.
   PubMed Web of Science ®Google Scholar
• Xu X, Han M, Li T, et al. Effective treatment of severe COVID-19 patients with tocilizumab. Proc Natl Acad Sci U S A. 2020;117:10970–10975.
   PubMed Web of Science ®Google Scholar
• Xu Y, Wang D, Mason B, et al. Structure, heterogeneity and developability assessment of therapeutic antibodies. MAbs. 2019;11:239–264.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Guo J. Characterization and QC of biopharmaceuticals by MS-based ‘multi-attribute method’: advantages and challenges. Bioanalysis. 2017;9:499–502.
   PubMed Web of Science ®Google Scholar
• Rogers RS, Nightlinger NS, Livingston B, et al. Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics. MAbs. 2015;7:881–890.
   PubMed Web of Science ®Google Scholar
• Bomans K, Haberger M, Bonnington L, et al. Monitoring of antibody modifications by semi-automated liquid chromatography mass spectrometry peptide mapping. Am Pharm Rev. 2016;19:16–21.
   Google Scholar
• Rogstad S, Yan H, Wang X, et al. Multi-attribute method for quality control of therapeutic proteins. Anal Chem. 2019;91:14170–14177.
   PubMed Web of Science ®Google Scholar
• Chelius D, Rehder DS, Bondarenko PV. Identification and characterization of deamidation sites in the conserved regions of human immunoglobulin gamma antibodies. Anal Chem. 2005;77:6004–6011.
   PubMed Web of Science ®Google Scholar
• Ren D, Pipes GD, Liu D, et al. An improved trypsin digestion method minimizes digestion-induced modifications on proteins. Anal Biochem. 2009;392:12–21.
   PubMed Web of Science ®Google Scholar
• Bults P, Bischoff R, Bakker H, et al. MS/MS-based monitoring of in vivo protein biotransformation: quantitative determination of trastuzumab and its deamidation products in human plasma. Anal Chem. 2016;88:1871–1877.
   PubMed Web of Science ®Google Scholar
• Krokhin OV, Antonovici M, Ens W, et al. Deamidation of -Asn-Gly- sequences during sample preparation for proteomics: consequences for MALDI and HPLC-MALDI analysis. Anal Chem. 2006;78:6645–6650.
   PubMed Web of Science ®Google Scholar
• Segu Z, Stone T, Berdugo C, et al. A rapid method for relative quantification of N-glycans from a therapeutic monoclonal antibody during trastuzumab biosimilar development. MAbs. 2020;12:1750794.
   PubMed Web of Science ®Google Scholar
• Wang X, Mathieu M, Brezski RJ. IgG Fc engineering to modulate antibody effector functions. Protein Cell. 2018;9:63–73.
   PubMed Web of Science ®Google Scholar
• Li W, Zhu Z, Chen W, et al. Crystallizable fragment glycoengineering for therapeutic antibodies development. Front Immunol. 2017;8:1554.
   PubMed Web of Science ®Google Scholar
• Aoyama M, Hashii N, Tsukimura W, et al. Effects of terminal galactose residues in mannose alpha1-6 arm of Fc-glycan on the effector functions of therapeutic monoclonal antibodies. MAbs. 2019;11:826–836.
   PubMed Web of Science ®Google Scholar
• Vlasak J, Bussat MC, Wang S, et al. Identification and characterization of asparagine deamidation in the light chain CDR1 of a humanized IgG1 antibody. Anal Biochem. 2009;392:145–154.
   PubMed Web of Science ®Google Scholar
• Bertolotti-Ciarlet A, Wang W, Lownes R, et al. Impact of methionine oxidation on the binding of human IgG1 to Fc Rn and Fc gamma receptors. Mol Immunol. 2009;46:1878–1882.
   PubMed Web of Science ®Google Scholar
• Pan H, Chen K, Chu L, et al. Methionine oxidation in human IgG2 Fc decreases binding affinities to protein A and FcRn. Protein Sci. 2009;18:424–433.
   PubMed Web of Science ®Google Scholar
• Wei Z, Feng J, Lin HY, et al. Identification of a single tryptophan residue as critical for binding activity in a humanized monoclonal antibody against respiratory syncytial virus. Anal Chem. 2007;79:2797–2805.
   PubMed Web of Science ®Google Scholar
• Hermeling S, Crommelin DJ, Schellekens H, et al. Structure-immunogenicity relationships of therapeutic proteins. Pharm Res. 2004;21:897–903.
   PubMed Web of Science ®Google Scholar
• Huang L, Lu J, Wroblewski VJ, et al. In vivo deamidation characterization of monoclonal antibody by LC/MS/MS. Anal Chem. 2005;77:1432–1439.
   PubMed Web of Science ®Google Scholar
• CaciaJ, KeckR, Presta LG, et al. Isomerization of an aspartic acid residue in the complementarity-determining regions of a recombinant antibody to human IgE: identification and effect on binding affinity. Biochemistry. 1996;35:1897–1903.
   PubMed Web of Science ®Google Scholar
• Wei B, Berning K, Quan C, et al. Glycation of antibodies: modification, methods and potential effects on biological functions. MAbs. 2017;9:586–594.
   PubMed Web of Science ®Google Scholar
• Chan WY, Chan TW, O’Connor PB. Electron transfer dissociation with supplemental activation to differentiate aspartic and isoaspartic residues in doubly charged peptide cations. J Am Soc Mass Spectrom. 2010;21:1012–1015.
   PubMed Web of Science ®Google Scholar
• Eakin CM, Miller A, Kerr J, et al. Assessing analytical methods to monitor isoAsp formation in monoclonal antibodies. Front Pharmacol. 2014;5:87.
   PubMed Web of Science ®Google Scholar
• International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. ICH Harmonized Tripartite Guidline, Pharmaceutical Dvelopment Q8 R2, August 2009.
   Google Scholar