Advanced search
Publication Cover
mAbs Volume 5, 2013 - Issue 6
Submit an article Journal homepage
2,106
Views
10
CrossRef citations to date
0
Altmetric
Report

Analytical characterization of a monoclonal antibody therapeutic reveals a three-light chain species that is efficiently removed using hydrophobic interaction chromatography

Rachel B Wollacott Process Development; MassBiologics of The University of Massachusetts Medical School; Boston, MA USACorrespondence[email protected]
,
Paul L Casaz Process Development; MassBiologics of The University of Massachusetts Medical School; Boston, MA USA
,
Trevor J Morin Product Discovery; MassBiologics of The University of Massachusetts Medical School; Boston, MA USA
,
H Lily Zhu Process Development; MassBiologics of The University of Massachusetts Medical School; Boston, MA USA
,
Roger S Anderson Process Development; MassBiologics of The University of Massachusetts Medical School; Boston, MA USA
,
Gregory J Babcock Product Discovery; MassBiologics of The University of Massachusetts Medical School; Boston, MA USA
,
John Que Process Development; MassBiologics of The University of Massachusetts Medical School; Boston, MA USA
,
William D Thomas Jr Process Development; MassBiologics of The University of Massachusetts Medical School; Boston, MA USA
&
Sadettin S Ozturk Process Development; MassBiologics of The University of Massachusetts Medical School; Boston, MA USA
 show all
Pages 925-935 | Received 25 Jun 2013, Accepted 16 Aug 2013, Published online: 19 Aug 2013

References

  • Hermeling S, Crommelin DJ, Schellekens H, Jiskoot W. Structure-immunogenicity relationships of therapeutic proteins. Pharm Res 2004; 21:897 - 903; http://dx.doi.org/10.1023/B:PHAM.0000029275.41323.a6; PMID: 15212151
  • Kumar S, Singh SK, Wang X, Rup B, Gill D. Coupling of aggregation and immunogenicity in biotherapeutics: T- and B-cell immune epitopes may contain aggregation-prone regions. Pharm Res 2011; 28:949 - 61; http://dx.doi.org/10.1007/s11095-011-0414-9; PMID: 21437790
  • Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J 2006; 8:E501 - 7; http://dx.doi.org/10.1208/aapsj080359; PMID: 17025268
  • Read EK, Park JT, Brorson KA. Industry and regulatory experience of the glycosylation of monoclonal antibodies. Biotechnol Appl Biochem 2011; 58:213 - 9; http://dx.doi.org/10.1002/bab.35; PMID: 21838794
  • Raju TS. Terminal sugars of Fc glycans influence antibody effector functions of IgGs. Curr Opin Immunol 2008; 20:471 - 8; http://dx.doi.org/10.1016/j.coi.2008.06.007; PMID: 18606225
  • Anthony RM, Ravetch JV. A novel role for the IgG Fc glycan: the anti-inflammatory activity of sialylated IgG Fcs. J Clin Immunol 2010; 30:Suppl 1 S9 - 14; http://dx.doi.org/10.1007/s10875-010-9405-6; PMID: 20480216
  • Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, Murphy BA, Satinover SM, Hosen J, Mauro D, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med 2008; 358:1109 - 17; http://dx.doi.org/10.1056/NEJMoa074943; PMID: 18337601
  • Yang J, Wang S, Liu J, Raghani A. Determination of tryptophan oxidation of monoclonal antibody by reversed phase high performance liquid chromatography. J Chromatogr A 2007; 1156:174 - 82; http://dx.doi.org/10.1016/j.chroma.2007.01.140; PMID: 17379231
  • Boyd D, Kaschak T, Yan B. HIC resolution of an IgG1 with an oxidized Trp in a complementarity determining region. J Chromatogr B Analyt Technol Biomed Life Sci 2011; 879:955 - 60; http://dx.doi.org/10.1016/j.jchromb.2011.03.006; PMID: 21440514
  • Gomez N, Vinson AR, Ouyang J, Nguyen MD, Chen X-N, Sharma VK, Yuk IH. Triple light chain antibodies: factors that influence its formation in cell culture. Biotechnol Bioeng 2010; 105:748 - 60; PMID: 19845001
  • Gomez N, Ouyang J, Nguyen MD, Vinson AR, Lin AA, Yuk IH. Effect of temperature, pH, dissolved oxygen, and hydrolysate on the formation of triple light chain antibodies in cell culture. Biotechnol Prog 2010; 26:1438 - 45; http://dx.doi.org/10.1002/btpr.465; PMID: 20568280
  • Lu C, Liu D, Liu H, Motchnik P. Characterization of monoclonal antibody size variants containing extra light chains. MAbs 2013; 5:102 - 13; http://dx.doi.org/10.4161/mabs.22965; PMID: 23255003
  • Rege K, Pepsin M, Falcon B, Steele L, Heng M. High-throughput process development for recombinant protein purification. Biotechnol Bioeng 2006; 93:618 - 30; http://dx.doi.org/10.1002/bit.20702; PMID: 16369981
  • Bhambure R, Kumar K, Rathore AS. High-throughput process development for biopharmaceutical drug substances. Trends Biotechnol 2011; 29:127 - 35; http://dx.doi.org/10.1016/j.tibtech.2010.12.001; PMID: 21255855

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:

Order Reprints Request Corporate Permissions

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:

Request Academic Permissions

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.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.