Unfolding and aggregation of a glycosylated monoclonal antibody on a cation exchange column. Part I. Chromatographic elution and batch adsorption behavior

Journal of Chromatography A

Volumn 1356, Issue , 2014, Pages 117-128

  Guo, Jing ^a   Zhang, Shaojie ^a   Carta, Giorgio ^a  

^a University of Virginia   (United States)

Author keywords

Aggregation; Cation exchange; Monoclonal antibody; Unfolding

Indexed keywords

AGGLOMERATION; AGGREGATES; BIOCHEMISTRY; CHROMATOGRAPHY; DESORPTION; DYES; MONOCLONAL ANTIBODIES; POLYMERS; POSITIVE IONS; RESINS;

BUFFER CONCENTRATIONS; CATION EXCHANGES; CONFOCAL LASER SCANNING MICROSCOPY; MACROPOROUS RESIN; MONOMERIC SPECIES; SALT CONCENTRATION; STRONG CATION EXCHANGE COLUMN; UNFOLDING;

PROTEINS;

GLYCOSYLATED PROTEIN; MONOCLONAL ANTIBODY; RESIN;

ADSORPTION KINETICS; ARTICLE; CATION EXCHANGE; CONCENTRATION (PARAMETERS); CONFOCAL LASER MICROSCOPY; DESORPTION; ELUTION; GEL PERMEATION CHROMATOGRAPHY; ION EXCHANGE CHROMATOGRAPHY; LIGHT SCATTERING; LINEAR SYSTEM; PH; PRIORITY JOURNAL; PROTEIN AGGREGATION; PROTEIN BINDING; PROTEIN FOLDING;

AGGREGATION; CATION EXCHANGE; MONOCLONAL ANTIBODY; UNFOLDING;

ADSORPTION; ANTIBODIES, MONOCLONAL; CATION EXCHANGE RESINS; CHROMATOGRAPHY, ION EXCHANGE; ELECTRIC CONDUCTIVITY; GLYCOPROTEINS; IMMUNOGLOBULIN G; MICROSCOPY, CONFOCAL; MOLECULAR WEIGHT; PROTEIN BINDING; PROTEIN MULTIMERIZATION; PROTEIN UNFOLDING;

EID: 84904757929     PISSN: 00219673     EISSN: 18733778     Source Type: Journal    
DOI: 10.1016/j.chroma.2014.06.037     Document Type: Article

References (44)

1. Reichert J.M. Monoclonal antibodies as innovative therapeutics. J. Curr. Pharm. Biotechnol. 2008, 9:423-430.
2. Wang W., Singh S., Zeng D.L. Antibody structure, instability, and formulation. J. Pharm. Sci. 2007, 96:1-26.
3. Rosenberg A.S. Effects of protein aggregates: an immunologic perspective. AAPS J. 2006, 8:E501-E507.
4. Cleland J.L., Powell M.F., Shire S.J. The development of stable protein formulations - a close look at protein aggregation, deamidation, and oxidation. Crit. Rev. Ther. Drug Carr. Syst. 1993, 10:307-377.
5. Shukla A., Hubbard B.B., Tressel T., Guhan S., Low D. Downstream processing of monoclonal antibodies - Application of platform approaches. J. Chromatogr. B 2007, 848:28-39.
6. Stein A., Kiesewetter A. Cation exchange chromatography in antibody purification: pH screening for optimised binding and HCP removal. J. Chromatogr. B 2007, 848:151-158.
7. Ishihara T., Kadoya T., Yoshida H., Tamada T., Yamamoto S. Rational methods for predicting human monoclonal antibodies retention in protein A affinity chromatography and cation exchange chromatography - Structure-based chromatography design for monoclonal antibodiesm. J. Chromatogr. A 2005, 1093:126-138.
8. Staby A.M.-B., Hansen R.G.R.G., Jacobsen J.H., Andersen L.A., Gerstenberg M., Jensen I.H. Comparison of chromatographic ion-exchange resins - IV. Strong and weak cation-exchange resins and heparin resins. J. Chromatogr. A 2005, 1069:65-77.
9. Karger B.L., Blanco R. The effect of on-column structural-changes of proteins on their hplc behavior. Talanta 1989, 36:243-248.
10. McNay J.L., Fernandez E.J. How does a protein unfold on a reversed-phase liquid chromatography surface?. J. Chromatogr. A 1999, 849:135-148.
11. Jungbauer A., Machold C., Hahn R. Hydrophobic interaction chromatography of proteins - III. Unfolding of proteins upon adsorption. J. Chromatogr. A 2005, 1079:221-228.
12. Xiao Y., Freed A.S., Jones T.T., Makrodimitris K., O'Connell J.P., Fernandez E.J. Protein instability during HIC: Describing the effects of mobile phase conditions on instability and chromatographic retention. Biotechnol. Bioeng. 2006, 93:1177-1189.
13. Muca R., Marek W., Piatkowski W., Antos D. Influence of the sample-solvent on protein retention, mass transfer and unfolding kinetics in hydrophobic interaction chromatography. J. Chromatogr. A 2010, 1217:2812-2820.
14. Marek W., Piatkowski W., Antos D. Multiple-injection technique for isolating a target protein from multicomponent mixtures. J. Chromatogr. A 2011, 1218:5423-5433.
15. Zhang L., Zhao G., Sun Y. Molecular insight into protein conformational transition in hydrophobic charge induction chromatography: a molecular dynamics simulation. J. Phys. Chem. B 2009, 113:6873-6880.
16. Voitl A., Butté A., Morbidelli M. Behavior of human serum albumin on strong cation exchange resins: I. Experimental analysis. J. Chromatogr. A 2010, 1217:5484-5500.
17. Gillespie R., Nguyen T., Macneil S., Jones L., Crampton S., Vunnum S. Cation exchange surface-mediated denaturation of an aglycosylated immunoglobulin (IgG1). J. Chromatogr. A 2012, 1251:101-110.
18. Marek W., Muca R., Wos S., Piatkowski W., Antos D. Isolation of monoclonal antibody from a Chinese hamster ovary supernatant. II: Dynamics of the integrated separation on ion exchange and hydrophobic interaction chromatography media. J. Chromatogr. A 2013, 1305:64-75.
19. He F., Hogan S., Latypov R.F., Narhi L.O., Razinkov V.I. High throughput thermostability screening of monoclonal antibody formulations. J. Pharm. Sci. 2010, 99:1707-1720.
20. Houde D., Arndt J., Domeier W., Berkowitz S., Engen J.R. Characterization of IgG1 conformation and conformational dynamics by hydrogen/deuterium exchange mass spectrometry. Anal. Chem. 2009, 81:2644-2651.
21. Lenhoff A.M. Protein adsorption and transport in polymer-functionalized ion-exchangers. J. Chromatogr. A 2011, 1218:8748-8759.
22. Stone M.C., Tao Y., Carta G. Protein adsorption and transport in agarose and dextran-grafted agarose media for ion exchange chromatography: Effect of ionic strength and protein characteristics. J. Chromatogr. A 2009, 1216:4465-4474.
23. Tao Y., Carta G., Ferreira G., Robbins D. Adsorption of deamidated antibody variants on macroporous and dextran-grafted cation exchangers: I. Adsorption equilibrium. J. Chromatogr. A 2011, 1218:1519-1529.
24. Perez-Almodovar E.X., Tao Y., Carta G. Protein adsorption and transport in cation exchangers with a rigid backbone matrix with and without polymeric surface extenders. Biotechnol. Progr. 2011, 27:1264-1272.
25. Pabst T.M., Antos D., Carta G., Ramasubramanyan N., Hunter A.K. Protein separations with induced pH gradients using cation-exchange chromatographic columns containing weak acid groups. J. Chromatogr. A 2008, 1181:83-94.
26. Pabst T.M. Ph.D. Dissertation 2008, University of Virginia, Charlottesville, VA.
27. Mattison K., Morfesis A., Kaszuba M. A primer on particle sizing using dynamic light scattering. Am. Biotechnol. Lab. 2003, 21:20-22.
28. Carta G., Ubiera A.R., Pabst T.M. Protein mass transfer kinetics in ion exchange media: Measurements and interpretations. Chem. Eng. Technol. 2005, 28:1252-1264.
29. Tao Y., Pérez Almodóvar E.X., Carta G., Ferreira G., Robbins D.D. Adsorption kinetics of deamidated antibody variants on macroporous and dextran-grafted cation exchangers. III. Microscopic studies. J. Chromatogr. A 2011, 1218:8027-8035.
30. Ahrer K., Buchacher A., Iberer G., Josic D., Jungbauer A. Analysis of aggregates of human immunoglobulin G using size-exclusion chromatography, static and dynamic light scattering. J. Chromatogr. A 2003, 1009:89-96.
31. Brummitt R.K., Nesta D.P., Chang L., Kroetsch A.M., Roberts C.J. Nonnative aggregation of an IgG1 antibody in acidic conditions, Part 2: nucleation and growth kinetics with competing growth mechanisms. J. Pharm. Sci. 2011, 100:2104-2119.
32. Perez Almodovar E.X., Glatz B., Carta G. Counterion effects on protein adsorption equilibrium and kinetics in polymer-grafted cation exchangers. J. Chromatogr. A 2012, 1253:83-93.
33. Andersen C.B., Manno M., Rischel C., Thorolfsson M., Martorana V. Aggregation of a multidomain protein: A coagulation mechanism governs aggregation of a model IgG1 antibody under weak thermal stress. Protein Sci. 2010, 19:279-290.
34. Feder J., Jossang T. Scaling behavior and cluster fractal dimension determined by light-scattering from aggregating proteins. Phys. Rev. Lett. 1984, 53:1403-1406.
35. Jossang T., Feder J., Rosemqvist E. Heat aggregation kinetics of human IgG. J. Chem. Phys. 1985, 82:574-589.
36. Stone M.C., Carta G. Protein adsorption and transport in agarose and dextran-grafted agarose media for ion exchange chromatography. J. Chromatogr. A 2007, 1146:202-215.
37. Fogle J.L., O'Connell J.P., Fernandez E.J. Loading, stationary phase, and salt effects during hydrophobic interaction chromatography: alpha-lactalbumin is stabilized at high loadings. J. Chromatogr. A 2006, 1121:209-218.
38. Haimer E., Tscheliessnig A., Hahn R., Jungbauer A. Hydrophobic interaction chromatography of proteins IV. Kinetics of protein spreading. J. Chromatogr. A 2007, 1139:84-94.
39. Lundstrom I. Model of protein adsorption on solid surfaces. Prog. Colloid Polym. Sci. 1985, 70:76-82.
40. McCue J.T., Engel P.A.Ng., Mcniven R., Thömmes J. Modeling of protein monomer/aggregate purification and separation using hydrophobic interaction chromatography. Bioprocess. Biosyst. Eng. 2008, 31:261-275.
41. Yang H., Etzel M.R. Evaluation of three kinetic equations in models of protein purification using ion-exchange membranes. Ind. Eng. Chem. Res. 2003, 42:890-896.
42. Sane S.U., Cramer S.M., Przybycien T.M. Protein structure perturbations on chromatographic surfaces. J. Chromatogr. A 1999, 849:149-159.
43. Stone M.C., Carta G. Patterns of protein adsorption in chromatographic particles visualized by optical microscopy. J. Chromatogr. A 2007, 1160:206-214.
44. Weber T.W., Chakravorti R.K. Pore and solid diffusion models for fixed-bed adsorbers. AIChE J. 1974, 20:228-238.