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Developability studies before initiation of process development

Improving manufacturability of monoclonal antibodies

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Pages 787-794 | Received 28 Apr 2013, Accepted 03 Jun 2013, Published online: 07 Jun 2013

References

  • Reichert JM. Metrics for antibody therapeutics development. MAbs 2010; 2:695 - 700; http://dx.doi.org/10.4161/mabs.2.6.13603; PMID: 20930555
  • Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol 2009; 27:26 - 34; http://dx.doi.org/10.1038/nbt0109-26; PMID: 19131992
  • Hawe A, Wiggenhorn M, van de Weert M, Garbe JH, Mahler HC, Jiskoot W. Forced degradation of therapeutic proteins. J Pharm Sci 2012; 101:895 - 913; http://dx.doi.org/10.1002/jps.22812; PMID: 22083792
  • Yan B, Valliere-Douglass J, Brady L, Steen S, Han M, Pace D, et al. Analysis of post-translational modifications in recombinant monoclonal antibody IgG1 by reversed-phase liquid chromatography/mass spectrometry. J Chromatogr A 2007; 1164:153 - 61; http://dx.doi.org/10.1016/j.chroma.2007.06.063; PMID: 17640657
  • Keck RG. The use of t-butyl hydroperoxide as a probe for methionine oxidation in proteins. Anal Biochem 1996; 236:56 - 62; http://dx.doi.org/10.1006/abio.1996.0131; PMID: 8619496
  • International Conference on Harmonisation. Guidance for Industry, Q1B “Photostability Testing of New Drug Substances and Product”, ICH-Q1B. 1996 November. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1B/Step4/Q1B_Guideline.pdf
  • Robinson NE, Robinson AB. Molecular Clocks: Deamidation of Asparaginyl and Glutaminyl Residues in Peptides and Proteins. 2004 Althouse Press, Cave Junction, OR.
  • Du Y, Walsh A, Ehrick R, Xu W, May K, Liu H. Chromatographic analysis of the acidic and basic species of recombinant monoclonal antibodies. MAbs 2012; 4:578 - 85; http://dx.doi.org/10.4161/mabs.21328; PMID: 22820257
  • Wypych J, Li M, Guo A, Zhang Z, Martinez T, Allen MJ, et al. Human IgG2 antibodies display disulfide-mediated structural isoforms. J Biol Chem 2008; 283:16194 - 205; http://dx.doi.org/10.1074/jbc.M709987200; PMID: 18339624