Glycoprotein analysis by capillary electrophoresis

Handbook of Capillary and Microchip Electrophoresis and Associated Microtechniques, Third Edition

Volumn , Issue , 2007, Pages 631-706

  Girard, Michel ^a   Lacunza, Izaskun ^b   Diez Masa, Jose Carlos ^b   De Frutos, Mercedes ^b  

^a HEALTH CANADA   (Canada)

^b INSTITUTO DE QUÍMICA ORGÁNICA GENERAL   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85057692442     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (225)

1. Dwek, R.A., Glycobiology: Toward understanding the function of sugars, Chem. Rev., 96, 683, 1996.
2. Taylor, M.E. and Drickamer, K., Introduction to Glycobiolgy, Oxford University Press, New York, 2004, chap. 12.
3. Brockhausen, I. and Kuhns, W., Glycoproteins and Human Disease, Springer-Verlag, Heidelberg, Germany, 1997, chap. 2.
4. Durand, G. and Seta, N., Protein glycosylation and diseases: Blood and urinary oligosaccharides as markers for diagnosis and therapeutic monitoring, Clin. Chem., 46, 795, 2000.
5. Walsh, G., Pharmaceutical biotechnology products approved within the European Union, Eur. J. Pharm. Biopharm., 55, 3, 2003.
6. Walsh, G., Second-generation biopharmaceuticals, Eur. J. Pharm. Biopharm., 58, 185, 2004.
7. Jenkins, N. and Curling, M.A., Glycosylation of recombinant proteins: Problems and prospects, Enzyme Microb. Technol., 16, 354, 1994.
8. Jung, E. and Williams, K.L., The production of recombinant glycoproteins with special reference to simple eukaryotes including Dictyostelium discoideum, Biotechnol. Appl. Biochem., 25, 3, 1997.
9. Varki, A. et al., Essentials of Glycobiology, Cold Spring Harbor Laboratory Press, New York, 1999, chap. 2.
10. Taylor, M.E. and Drickamer, K., Introduction to Glycobiolgy, Oxford University Press, New York, 2004, chap. 2.
11. Strege, M.A. and Lagu, A.L., Capillary Electrophoresis of Proteins and Peptides, Meth. Mol. Biol., Humana Press, Inc., NJ, 2004, Vol. 276.
12. Prichett, T. and Robey, F.A., Capillary electrophoresis of proteins, in Handbook of Capillary Electrophoresis, Landers, J.P., Ed., CRC Press, Boca Raton, FL, 1997, chap. 9.
13. Kakehi, K., Kinoshita, M., and Nakano, M., Analysis of glycoproteins and the oligosaccharides thereof by high-performance capillary electrophoresis-Significance in regulatory studies on biopharmaceutical products, Biomed. Chromatogr., 16, 103, 2002.
14. Pantazaki, A., Taverna, M., and Vidal-Madjar, C., Recent advances in the capillary electrophoresis of recombinant glycoproteins, Anal. Chim. Acta, 383, 137, 1999.
15. Taverna, M. et al., Electrophoretic methods for process monitoring and the quality assessment of recombinant glycopropteins, Electrophoresis, 19, 2572, 1999.
16. Taverna, M., Tran, N.T., and Ferrier, D., Separation of protein glycoforms by capillary electrophoresis, Meth. Mol. Biol. 213, 163, 2003.
17. Kamoda, S. and Kakehi, K., Capillary electrophoresis for the analysis of glycoprotein pharmaceuticals, Electrophoresis, 27, 2495, 2006.
18. Watzig, H., Degenhardt, M., and Kunkel, A., Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications, Electrophoresis, 19, 2695, 1998.
19. Chen, A.B. and Canova-Davis, E., Capillary electrophoresis in the development of recombinant protein biopharmaceuticals, Chromatographia Suppl., 53, S7, 2001.
20. Patrick, J.S. and Lagu, A.L., Review applications of capillary electrophoresis to the analysis of biotechnology-derived therapeutic proteins, Electrophoresis, 22, 4179, 2001.
21. Mechref, Y. and Novotny, M.V., Structural investigations of glycoconjugates at high sensitivity, Chem. Rev., 102, 321, 2002.
22. Little, M.J., Paquette, D.M., and Roos, P.K., Electrophoresis of pharmaceutical proteins: Status quo, Electrophoresis, 27, 2477, 2006.
23. Dolnik, V., Capillary electrophoresis of proteins 2003-2005, Electrophoresis, 27, 126, 2006.
24. Huck, C.W., Bakry, R., and Bonn, G.K., Progress in capillary electrophoresis of biomarkers and metabolites between 2002 and 2005, Electrophoresis, 27, 111, 2006.
25. Kishino, S. and Miyazaki, K., Separation methods for glycoprotein analysis and preparation, J. Chromatogr. A, 699, 371, 1997.
26. El Rassi, Z., Recent developments in capillary electrophoresis of carbohydrate species, Electrophoresis, 18, 2400, 1997.
27. Grossman, P.D., Free-solution capillary electrophoresis, in Capillary Electrophoresis. Theory and Practice, Grossman, P.D. and Colburn J.C., Eds., Academic Press, New York, 1992, chap. 2.
28. Kalman, F. et al., Charge and size effect in capillary zone electrophoresis of nuclease A and variants, Electrophoresis, 16, 595, 1995.
29. Gitlin, I., Carbeck, J.D., and Whitesides, G.M., Why are proteins charged? Network of charge-charge interaction in proteins measured by charge ladders and capillary electrophoresis, Angew. Chem. Int. Ed., 45, 3022, 2006.
30. Balaguer, E. et al., Glycoform characterization of erythropoietin combining glycan and intact protein analysis by capillary electrophoresis-electrospray-time-of-flight mass spectrometry, Electrophoresis, 27, 2638, 2006.
31. Yim, K., Abrams, J., and Hsu, A., Capillary zone electrophoretic resolution of recombinant human bone morphogenic protein 2 glycoforms. An investigation into the separation mechanisms for an exquisite separation, J. Chromatogr. A, 716, 401, 1995.
32. Chen, F.-T.A., Rapid protein analysis by capillary electrophoresis, J. Chromatogr., 559, 445, 1991.
33. van der Greef, J., Stroobant, P., and van der Heijden, R., The role of analytical sciences in medical systems biology, Curr. Opin. Chem. Biol., 8, 559, 2004.
34. Bristow, A. and Charton, E., Assessment of the suitability of a capillary zone electrophoresis method for determining isoform distribution of erythropoietin Pharmaeuropa, 11, 290, 1999.
35. Erythropoietin concentrated solution 01/2005:1316, European Pharmacopoeia 5th edition, published by EDQM. June 2004.
36. Cifuentes, A. et al., Capillary isoelectric focusing of erythropoietin glycoforms and its comparison with flat-bed isoelectric focusing and capillary zone electrophoresis, J. Chromatogr. A, 830, 453, 1999.
37. San-Nebot, V. et al., Separation of recombinant human erythropoietin glycoforms by capillary electrophoresis using volatile electrolytes. Assessment of mass spectrometry for the characterization of erythropoietin glycoforms, Anal. Chem., 75, 5220, 2003.
38. Lacunza, I. et al., Selection of migration parameters for a highly reliable assignment of bands of isoforms of erythropoietin separated by capillary electrophoresis, Electrophoresis, 25, 1569, 2004.
39. Lopez-Soto-Yarritu, P. et al., Improved capillary isoelectric focusing method for recombinant erythropoietin analysis, J. Chromatogr. A, 968, 221, 2002.
40. de Frutos, M., Cifuentes, A., and Diez-Masa, J.C., Differences in capillary electrophoresis profiles of urinary and recombinant erythropoietin, Electrophoresis, 24, 678, 2003.
41. Bietlot, H.P. and Girard, M., Analysis of recombinant human erythropoietin in drug formulations by high performance capillary electrophoresis, J. Chromatogr. A, 759, 177, 1997.
42. Neususs, C., Demelbauer, U., and Pelzing, M., Glycoform characterization of intact erythropoietin by capillary electrophoresis-electrospray-time of flight-mass spectrometry, Electrophoresis, 26, 1442, 2005.
43. Lara-Quintanar, P. et al., Immunochromatographic removal of albumin in erythropoietin biopharmaceutical formulations for its analysis by capillary electrophoresis, J. Chromatogr. A, 1153, 227, 2007.
44. Hjerten, S., Zone broadening in electrophoresis with special reference to the high-performance electrophoresis in capillaries:Aninterplay between theory and practice, Electrophoresis, 11, 665, 1990.
45. Lauer, H.H. and McManigill, D., Capillary zone electrophoresis of proteins in untreated fused silica tubing, Anal. Chem., 58, 166, 1986.
46. McCormick, R.A., Capillary zone electrophoretic separation of peptides and proteins using low pH buffers in modified silica capillaries, Anal. Chem., 6, 2322, 1986.
47. Corradini, D., Buffer additives other than the surfactant sodium dodecyl sulfate for protein separation by capillary electrophoresis, J. Chromatogr. B, 699, 21, 1997.
48. Righetti, P.G. et al., The state of the art of dynamic coatings, Electrophoresis, 22, 603, 2001.
49. Ahmadzadeh, H., Dovichi, N.J., and Krylov, S. Capillary coating for protein separation on Si--O and Si--C covalent bond formation for capillary electrophoresis with laser-induced fluorescence detection, in Capillary Electrophoresis of Proteins and Peptides, Strege, M.A. and Lagu, A.L., Eds., Humana Press, Totowa, NJ, 2004, chap. 2.
50. Landers, J.P. et al., High performance capillary electrophoresis of glycoproteins: The use of modifiers of electroosmotic flow for analysis of microheterogeneity, Anal. Biochem., 205, 115, 1992.
51. Legaz, M.E. and Pedrosa, M.M., Effect of polyamines on the separation of ovalbumin glycoforms by capillary electrophoresis, J. Chromatogr. A, 719, 159, 1996.
52. Watson, E. and Yao, F., Capillary electrophoretic separation of human recombinant erythropoietin (r-HuEPO) glycoforms, Anal. Biochem., 210, 389, 1993.
53. Klausen, N.K. and Kornfelt, T., Analysis of the glycoforms of human recombinant factor VIIa by capillary electrophoresis and high-performance liquid chromatography, J. Chromatogr. A, 718, 195, 1995.
54. Watson, E. and Yao, F., Capillary electrophoretic separation of recombinant granulocyte-colonystimulating factor glycoforms, J. Chromatogr., 630, 442, 1993.
55. Oda, R.P. and Landers, J.P., Effect of cationic buffer additives on the capillary electrophoretic separation of serum transferrin from different species, Electrophoresis, 17, 431, 1996.
56. Morbeck, D.E., Madden, B.J., and McCormick, D.J., Analysis of the microheterogeneity of the glycoprotein chorionic gonadotropin with high-performance capillary electrophoresis, J. Chromatogr. A, 680, 217, 1994.
57. Oda, R.P. et al. α,ω-Bis quaternary ammonium alkanes as effective buffer additives for enhanced capillary electrophoretic separation of glycoproteins, J. Chromatogr. A, 680, 85, 1994.
58. Verzola, B., Gelfi, C., and Righetti, P.G., Protein adsorption to the bare silica wall in capillary electrophoresis. Quantitative study on the chemical composition of the background electrolyte for minimizing the phenomenon, J. Chromatogr. A, 868, 85, 2000.
59. Wicktorowicz, J.E. and Colburn, J.E., Separation of cationic proteins via charge reversal in capillary electrophoresis, Electrophoresis, 11, 769, 1990.
60. Cordova, E., Gao, J., and WhitesidesG.M., Noncovalent polycationic coating for capillaries in capillary electrophoresis of proteins, Anal. Chem., 69, 1370, 1997.
61. Kelly, J.F. et al., Development of electrophoretic conditions for the characterization of protein glycoforms by capillary electrophoresis-electrospray mass spectrometry, J. Chromatogr. A, 720, 409, 1996.
62. Yu, B. et al., Ionene-dynamically coated capillary for analysis of urinary and recombinant human erythropoietin by capillary electrophoresis and online electrospray ionization mass spectrometry, J. Sep. Sci., 28, 2390, 2005.
63. Katayama, H., Ishihama, Y., and Asakawa, N., Stable capillary coating with successive multiple ionic polymer layers, Anal. Chem., 70, 2254, 1998.
64. Bendahl, L., Hansen, S.H., and Gammelgaard, B., Capillaries modified by noncovalently anionic polymer adsorption for capillary zone electrophoresis, micellar electrokinetic capillary chromatography and capillary electrophoresis, Electrophoresis, 22, 2565, 2001.
65. Graul, T.W. and Schlenoff, J.B., Capillaries modified by polyelectrolyte multilayers for electrophoretic separations, Anal. Chem., 71, 4007, 1999.
66. Lanz, C., Marti, U., and Thormann, W., Capillary zone electrophoresis with a dynamic double coating for analysis of carbohydrate-deficient transferrin in human serum. Precision performance and pattern recognition, J. Chromatogr. A, 1013, 131, 2003.
67. Joneli, J., Lanz, C., and Thormann, W., Capillary zone electrophoresis determination of carbohydratedeficient transferrin using the new Ceofix reagents under high-resolution conditions, J. Chromatogr. A, 1130, 272, 2006.
68. Legros, F.J. et al., Carbohydrate-deficient transferrin isoforms measured by capillary zone electrophoresis for detection of alcohol abuse, Clin. Chem., 48, 2177, 2002.
69. Legros, F.J. et al., Use of capillary zone electrophoresis for differentiating excessive from moderate alcohol consumption, Clin. Chem., 49, 440, 2003.
70. Chang, W.W.P. et al., Rapid separation of protein isoforms by capillary zone electrophoresis with new dynamic coating, Electrophoresis, 26, 2179, 2005.
71. Balaguer, E. and Neususs, C., Glycoprotein characterization combining intact protein and glycan analysis by capillary electrophoresis-electrospray ionization-mass spectrometry, Anal. Chem., 78, 5384, 2006.
72. Hjerten, S., High-performance electrophoresis. Elimination of the electroendosmosis and solute adsorption, J. Chromatogr., 347, 191, 1985.
73. Schmalzing, D. et al., Characterization and performance of a neutral hydrophilic coating for the capillary electrophoretic separation of biopolymers, J. Chromatogr. A., 652, 149, 1993.
74. Hjerten, S. and Kubo, K., A new type of pH- and detergent stable coating for elimination of electroendosmosis and adsorption in (capillary) electrophoresis, Electrophoresis, 14, 390, 1993.
75. Gilges, M., Kleemiss, M.H., and Schomburg, G., Capillary zone electrophoresis separation of basic and acidic proteins using poly(vinyl alcohol) coatings in fused silica capillaries, Anal. Chem., 66, 2038, 1994.
76. Yim, K., Fractionation of the human recombinant tissue plasminogen activator (rtPA) glycoforms by high-performance capillary zone electrophoresis and capillary isoelectric focusing, J. Chromatogr., 559, 401, 1991.
77. Thorne, J.M. et al., Examination of capillary zone electrophoresis, capillary isoelectric focusing and sodium dodecyl sulphate capillary electrophoresis for the analysis of recombinant tissue plasminogen activator, J. Chromatogr. A, 744, 155, 1996.
78. Kinoshita, M. et al., Comparative studies on the analysis of glycosylation heterogeneity of sialic acid-containing glycoproteins using capillary electrophoresis, J. Chromatogr. A, 866, 261, 2000.
79. Kilar, F. and Hjerten, S., Separation of the human transferrin isoforms by carrier-free high-performance zone electrophoresis and isoelectric focusing, J. Chromatogr. A, 480, 351, 1989.
80. Hunt, G., Moorhouse, K.G., and Chen, A.B., Capillary isoelectric focusing and sodium dodecyl sulfatecapillary gel electrophoresis of recombinant humanized monoclonal antibody HER2, J. Chromatogr. A, 744, 295, 1996.
81. Grossman, P.D. et al., Application of free-solution capillary electrophoresis to the analytical scale separation of proteins and peptides, Anal. Chem., 61, 1186, 1989.
82. Taverna, M. et al., Analysis of carbohydrate-mediated heterogeneity and characterization of N-linked oligosaccharies of glycoproteins by high performance capillary electrophoresis, Electrophoresis, 13, 359, 1992.
83. Sanz-Nebot, V. et al., Capillary electrophoresis and matrix-assisted laser desorption/ionization-time of flight-mass spectrometry for analysis of the novel erythropoiesis-stimulating protein (NESP), Electrophoresis, 26, 1451, 2005.
84. Lacunza, I. et al., CZE of human alpha-1-acid glycoprotein for qualitative and quantitative comparison of samples from different pathological conditions, Electrophoresis, 27, 4205, 2006.
85. Honda, S. et al., Simultaneous determination of reducing monosaccharides by capillary zone electrophoresis as the borate complexes of N-2 pyridylglycamines, Anal. Biochem., 176, 72, 1989.
86. Hoffsteter-Kuhn, S. et al., Influence of borate complexation on the electrophoretic behavior of carbohydrates in capillary electrophoresis, Anal. Chem., 63, 1541, 1991.
87. Pacakova, V. et al., Effects of electrolyte modification and capillary coating on separation of glycoproteins isoforms by capillary electrophoresis, Electrophoresis, 22, 459, 2001.
88. Chen, Y., Critical conditions for separating the microheterogeneous components of glycoproteins by capillary electrophoresis, J. Chromatogr. A, 768, 39, 1997.
89. Oda, R.P. et al., Capillary electrophoresis-based separation of transferrin sialoforms in patients with carbohydrate-deficient glycoprotein syndrome, Electrophoresis, 18, 1819, 1997.
90. Lopez-Soto-Yarritu, P. et al., Comparison of different capillary electrophoresis methods for analysis of recombinant erythropoietin glycoforms, J. Sep. Sci., 25, 1112, 2002.
91. Tran, A.D. et al., Separation of carbohydrate-mediated microheterogeneity of recombinant human erythropoietin by free solution capillary electrophoresis, J. Chromatogr., 542, 459, 1991.
92. Zhou, G.-H. et al., Application of capillary electrophoresis, liquid chromatography, electrospray-mass spectrometry and matrix-assisted laser desorption/ionization-time of flight-mass spectrometry to the characterization of recombinant human erythropoietin, Electrophoresis, 19, 2348, 1998.
93. Nieto, O., Hernandez, P., and Hernandez, L., Capillary zone electrophoresis of human recombinant erythropoietin using C8 coated columns without additives in the running buffer, Anal. Commun., 33, 425, 1996.
94. Kaniansky, D. et al., Capillary zone electrophoresis in a hydrodynamically closed separation system with enhanced sample loadability, J. Chromatogr. A, 772, 103, 1997.
95. Madajova, V. et al., Fractionation of glycoforms of recombinant human erythropoietin by preparative capillary isotachophoresis, Electrophoresis, 26, 2664, 2005.
96. Balaguer, E. and Neususs, C., Intact glycoform characterization of erythropoietin-α and erythropoietin-β by CZE-ESI-TOF-MS, Chromatographia, 64, 351, 2006.
97. Kilar, F. and Hjerten, S., Fast and high resolution analysis of human serum transferrin by high performance isoelectric focusing in capillaries, Electrophoresis, 10, 23, 1989.
98. Righetti, P.G., Determination of the isoelectric point of proteins by capillary isoelectric focusing, J. Chromatogr. A, 1037, 491, 2004.
99. Lacunza, I. and de Frutos, M., Different capillary isoelectric focusing approaches for analysis of α-1-acid glycoprotein, PACE Setter, 10, 5, 2006.
100. Wu, J., Li, S.-C., and Watson, A., Optimizing separation conditions for proteins and peptides using imaged capillary isoelectric focusing, J. Chromatogr. A, 817, 163, 1998.
101. Moorhouse, K.G. et al., Rapid one-step capillary isoelectric focusing method to monitor charged glycoforms of recombinant human tissue-type plasminogen activator, J. Chromatogr. A, 717, 61, 1995.
102. Reif, O.-W. and Freitag, R., Control of the cultivation process of antithrombin III and its characterization by capillary electrophoresis, J. Chromatogr. A, 680, 383, 1994.
103. Tran, N.T. et al., One-step capillary isoelectric focusing for the separation of the recombinant human immunodeficiency virus envelope glycoprotein glycoforms, J. Chromatogr. A, 866, 121, 2000.
104. Kubach, J. and Grimm, R., Non-native capillary isoelectric focusing for the analysis of the microheterogeneity of glycoproteins, J. Chromatogr. A, 737, 281, 1996.
105. Moorhouse, K.G., Rickel, C.A., and Chen, A.B., Electrophoretic separation of recombinant tissuetype plasminogen activator glycoforms: Validation issues for capillary isoelectric focusing methods, Electrophoresis, 17, 423, 1996.
106. Chen, A.B. et al., Comparison of ampholytes used for slab gel and capillary isoelectric focusing of recombinant tissue-type plasminogen activator glycoforms, J. Chromatogr. A, 744, 279, 1996.
107. Sebastiano, R. et al., Mass distribution and focusing properties of carrier ampholytes for isoelectric focusing: I. Novel and unexpected results, Electrophoresis, 27, 3919, 2006.
108. Simo, C. et al., Mass distribution, polydispersity and focusing properties of carrier ampholytes for IEF II: pH 4-6 intervals, Electrophoresis, 27, 4849, 2006.
109. Lacunza, I. et al., CIEF with hydrodynamic and chemical mobilization for the separation of forms of alpha-1-acid glycoprotein, Electrophoresis, 28, 1204, 2007.
110. Wehr, T., Rodriguez-Diaz, R., and Zhu, M., Recent advances in capillary isoelectric focusing, Chromatographia Suppl., 53, S45, 2001.
111. Righetti, P.G., Isoelectric Focusing: Theory, Methodology, and Applications, Elsevier Biomedical, Amsterdam, 1989, 1.
112. Schwer, C., Capillary isoelectric focusing: A routine method for protein analysis?, Electrophoresis, 16, 2121, 1995.
113. Rudd, P.M. et al., Separation and analysis of the glycoform populations of ribonuclease B using capillary electrophoresis, Glycoconj. J., 9, 86, 1992.
114. James, D.C. et al., High-resolution separation of recombinant human interferon-γ glycoforms by micellar electrokinetic capillary chromatography, Anal. Biochem., 222, 315, 1994.
115. Werner, W.E. et al., Size-dependent separation of proteins denatured inSDSby capillary electrophoresis using a replaceable sieving matrix, Anal. Biochem., 212, 253, 1993.
116. Buchacher, A. et al., High-performance capillary electrophoresis for in-process control in the production of antithrombin III and human clotting factor IX, J. Chromatogr. A, 802, 355, 1998.
117. Bergstrom, M. et al., Lectin affinity capillary electrophoresis in glycoform analysis applying the partial filling technique, J. Chromatogr. B, 809, 323, 2004.
118. Uegaki, K. et al., Simultaneous estimation of the association constants of glycoprotein glycoforms to a common protein by capillary electrophoresis, Anal. Biochem., 309, 269, 2002.
119. Thormann, W. and Mosher, R.A., High-resolution computer simulation of the dynamics of isoelectric focusing using carrier ampholytes: Focusing with concurrent electrophoretic mobilation is an isotachophoretic process, Electrophoresis, 27, 968, 2006.
120. Iourin, O. et al., The identification of abnormal glycoforms of serum transferrin in carbohydrate deficient glycoprotein syndrome type I by capillary zone electrophoresis, Glycoconj. J., 13, 1031, 1996.
121. Thibault, P. and Dovichi, N., General instrumentation and detection systems including mass spectrometry, in Capillary Electrophoresis. Theory and Practice, Camilleri, P., Ed., CRC Press, Boca Raton, FL, 1998, chap. 2.
122. http://probes.invitrogen.com/handbook/sections/0900.html Accessed January 2007.
123. Craig, D.B. and Dovichi, N.J., Multiple labeling of proteins, Anal. Chem., 70, 2493, 1998.
124. Tseng, W.-L., Lin, Y.-W., and Chang, H.-T., Improved separation of microheterogeinities and isoforms of proteins by capillary electrophoresis using segmental filling with SDS and PEO in the background electrolyte, Anal. Chem., 74, 4828, 2002.
125. Salas-Solano, O. et al., Optimization and validation of a quantitative capillary electrophoresis sodium dodecyl sulfate method for quality control and stability monitoring of monoclonal antibodies, Anal.Chem 78, 6583, 2006.
126. Pinto, D.M. et al., Picomolar assay of native proteins by capillary electrophoresis precolumn. Submicellar separation, and laser-induced fluorescence detection, Anal. Chem., 69, 3015, 1997.
127. Lee, I.H. et al., Picomolar analysis of proteins using electrophoretically mediated microanalysis and capillary electrophoresis with laser-induced fluorescence detection, Anal. Chem., 70, 4546, 1998.
128. Wehr, T., Rodriguez-Diaz, R., and Zhu, M., Capillary Electrophoresis of Proteins, Marcell Dekker, New York, 1999, chap. 3.
129. Bornemann, C. et al., Fluorescence-labelled antigen-binding fragments (Fab) from monoclonal antibody 5F12 detect human erythropoietin in immunoaffinity capillary electrophoresis, Anal. Bioanal. Chem., 376, 1074, 2003.
130. Kelly, J.A. and Lee, C.S., Online postcapillary affinity detection of immunoglobulin G subclass and monoclonal antibodies variants for capillary electrophoresis, J. Chromatogr. A, 790, 207, 1997.
131. Yeung, B., Porter, T.J., and Vath, J.E., Direct isoform analysis of high-mannose-containing glycoproteins by online capillary electrophoresis electrospray mass spectrometry, Anal. Chem., 69, 2510, 1997.
132. Demelbauer, U.M. et al., Characterization of glyco isoforms in plasma-derived human antithrombin by online capillary zone electrophoresis-electrospray ionization-quadrupole ion trap-mass spectrometry of the intact glycoproteins, Electrophoresis, 25, 2026, 2004.
133. Arizaga-Rodriguez, S. et al., Detection of transferrin isoforms in human serum: Comparison of UV and ICP-MS detection after CZE and HPLC separations, Anal. Bioanal. Chem., 383, 390, 2005.
134. Hooker, A.D. and James, D.C., Analysis of glycoprotein heterogeneity by capillary electrophoresis and mass spectrometry, Mol. Biotech., 14, 241, 2000.
135. Morelle, W. and Michalski, J.C., The mass spectrometric analysis of glycoproteins and their glycan structures, Curr. Anal. Chem., 1, 29, 2005.
136. Bateman, K.P. et al., Glycoprotein analysis by capillary zone electrophoresis-electrospray mass spectrometry, Meth. Mol. Biol., 213, 219, 2003.
137. Monton, M.R.N. and Terabe, S., Recent developments in capillary electrophoresis-Mass spectrometry of proteins and peptides, Anal. Sci., 21, 5, 2005.
138. Servais, A.-C., Crommen, J., and Fillet, M., Capillary electrophoresis-mass spectrometry, an attractive tool for drug bioanalysis and biomarker discovery, Electrophoresis, 27, 2616, 2006.
139. ICH Guidelines, http://www.ich.org/cache/compo/276-254-1.html, accessed November 2006.
140. Somatropin, 07/2007:0951, European Pharmacopoeia 5th edition, published by EDQM, April 2007.
141. Somerville, L.E., Douglas, A.J., and Irvine, A.E., Discrimination of granulocyte colony-stimulating factor isoforms by high-performance capillary electrophoresis, J. Chromatogr. B, 732, 81, 1999.
142. Berkowitz, S.A. et al., Rapid quantitative capillary zone electrophoresis method for monitoring the micro-heterogeneity of an intact recombinant glycoprotein, J. Chromatogr. A, 1079, 254, 2005.
143. Felten, C. et al., Use of acidic and basicpHand calcium ion addition in the capillary zone electrophoretic characterization of recombinant human deoxyribonuclease, a complex phosphoglycoprotein, J. Chromatogr. A, 853, 295, 1999.
144. Quan, C.P., Canova-Davis, E., and Chen, A.B., Effects of the solution environment on the resolution of recombinant human deoxyribonuclease variants in capillary zone electrophoresis, Chromatographia Suppl., 53, S39, 2001.
145. Kremser, L. et al., Characterization of antithrombin III from human plasma by two-dimensional gel electrophoresis and capillary electrophoretic methods. Electrophoresis, 24, 4282, 2003.
146. Che, F.Y. et al., Comparative study on the distribution of ovalbumin glycoforms by capillary electrophoresis, J. Chromatogr. A, 849, 599, 1999.
147. Kubo, K. and Hattori, A., Assessment of the capillary zone electrophoretic behaviour of proteins in the presence of electroosmotic modifiers: Protein-polyamine interaction studied using a polyacrylamide-coated capillary, Electrophoresis, 22, 3389, 2001.
148. Catai, J.R. et al., Noncovalently bilayer-coated capillaries for efficient and reproducible analysis of proteins by capillary electrophoresis, J. Chromatogr. A, 1083, 185, 2005.
149. Sandra, K. et al., Combining gel and capillary electrophoresis, nano-LC and mass spectrometry for the elucidation of posttranslational modifications of Trichoderma reesei cellobiohydrolase I., J. Chromatogr. A, 1058, 263, 2004.
150. Krull, I.S. et al., HPCE methods for the identification and quantitation of antibodies, their conjugates and complexes, J. Pharm. Biomed. Anal., 16, 377, 1997.
151. Santora, L.C., Krull, I.S., and Grant, K., Characterization of recombinant human monoclonal tissue necrosis factor-α antibody using cation-exchange HPLC and capillary isoelectric focusing, Anal. Biochem., 275, 98, 1999.
152. Harmon, B.J., Imaged capillary isoelectric focusing for the characterization and monitoring of charge heterogeneity of recombinant monoclonal antibodies, in Proceedings of the 5th Symposium on CE in the Biotechnology and Pharmaceutical Industries, San Francisco, CA, 2003.
153. Hoffstetter-Kuhn, S., Alt, G., and Kuhn, R. Profiling of oligosaccharide-mediated microheterogeneity of a monoclonal antibody by capillary electrophoresis, Electrophoresis, 17, 418, 1996.
154. Ma, S. in State of the Art Analytical Methods for the Characterization of Biological Products and Assessment of Comparability, Mire-Sluis, A.R., Ed., Karger, Basel, 2005, pp. 49-68.
155. Nunnally, B. et al., Aseries of collaborations between various pharmaceutical companies and regulatory authorities concerning the analysis of biomolecules using capillary electrophoresis, Chromatographia, 64, 359, 2006.
156. Jenkins, N., Parekh, R.B., and James, D.C., Getting the glycosylation right-Implications for the biotechnology industry, Nat. Biotechnol., 14, 975, 1996.
157. Chirino, A.J. and Mire-Sluis, A., Characterizing biological products and assessing comparability following manufacturing changes, Nat. Biotechnol., 22, 1383, 2004.
158. James, D.C. et al., Posttranslational processing of recombinant human interferon-γ in animal expression systems, Prot. Sci., 5, 331, 1996.
159. Goldman, M.H. et al., Monitoring recombinant human interferon-gamma N-glycosylation during perfused fluidized-bed and stirred-tank batch culture of CHO cells, Biotech. Bioeng., 60, 596, 1998.
160. Wang, M.D. et al., Erythropoietin production from CHO cells grown by continuous culture in a fluidized-bed bioreactor, Biotech. Bioeng., 77, 194, 2002.
161. Freitag, R., et al., Production of recombinant h-AT III with mammalian cell cultures using capillary electrophoresis for product monitoring, Cytotechnology, 21, 205, 1996.
162. Klyushnichenko, V., Capillary electrophoresis in the analysis and monitoring of biotechnological processes, Meth. Mol. Biol., 276, 77, 2004.
163. Schmelzer, A.E. and Miller, W.M., Hyperosmotic stress and elevated pCO2 alter monoclonal antibody charge distribution and monosaccharide content, Biotechnol. Prog., 18, 346, 2002.
164. Cherkaoui, S. et al., Development of a capillary zone electrophoresis method for caseinoglycomacropeptide determination, J. Chromatogr. A, 790, 195, 1997.
165. Cherkaoui, S. et al., Determination of the stability of caseinoglycomacropeptide in a cosmetic lotion by use of capillary zone electrophoresis with a coated capillary, Chromatographia, 50, 311, 1999.
166. Daali, Y., Cherkaoui, S., and Veuthey, J.L., Capillary electrophoresis and high-performance anion exchange chromatography for monitoring caseinoglycomacropeptide sialylation, J. Pharm. Biomed. Anal., 24, 849, 2001.
167. Donohue, M.J. et al., Capillary electrophoresis for the investigation of prostate-specific antigen heterogeneity, Anal. Biochem., 339, 318, 2005.
168. Girard, M., Boucher, S., and Kane, A., Analysis of erythropoietin preparations obtained from various sources worldwide by capillary zone electrophoresis, in Proceedings of the 7th International symposium on capillary electrophoresis in the biotechnology and pharmaceutical industries, Montreal, 2005.
169. Deechongkit, S. et al., Biophysical comparability of the same protein from different manufacturers: a case study using epoetin alfa from Epogen® and Eprex®, J. Pharm. Sci., 95, 1931, 2006.
170. Zhou, G.-H. et al., Characterization of recombinant human granulocyte colony stimulating factor (rHuG-CSF) by capillary zone electrophoresis, capillary isoelectric focusing electrophoresis and electrospray ionization mass spectrometry, J. Pharm. Biomed. Anal., 35, 425, 2004.
171. Storring, P.L. et al., Physicochemical Methods for predicting the biological potency of recombinant follicle stimulating hormone: An international collaborative study of isoelectric focusing and capillary zone electrophoresis, Biologicals, 30, 217, 2002.
172. Mulders, J.W.M., Wijn, H., and Theunissen, F. Development and validation of a capillary zone electrophoresis method which can be used to predict the in-vivo bioactivity of recombinant follicle stimulating hormone, in Proceedings of the 3rd Symposium on the Analysis of Well Characterized Biotechnology Pharmaceuticals (WCBP), Washington, DC, 1999.
173. Kim, Y.J. and Varki, A., Perspectives on the significance of altered glycosylation of glycoproteins in cancer, Glycoconj. J., 14, 569, 1997.
174. de Jong, G. and van Eijk, H.G., Microheterogeneity of human serum transferrin: A biological phenomenon studied by isoelectric focusing in immobilized pH gradients, Electrophoresis, 9, 589, 1998.
175. de Jong, G., van Dijk, J.P., and van Eijk, H.G., The biology of transferrin, Clin. Chim. Acta, 190, 1, 1990.
176. Arndt, T., Carbohydrate-deficient transferrin as a marker of chronic alcohol abuse: A critical review of preanalysis, analysis, and interpretation, Clin. Chem., 47, 13, 2001.
177. Wuyts, B. et al., Carbohydrate-deficient transferrin and chronic alcohol ingestion in subjects with transferrin CD-variants, Clin. Chem. Lab. Med., 39, 937, 2001.
178. Stibler, H., Carbohydrate-deficient transferrin in serum: A new marker of potentially harmful alcohol consumption reviewed, Clin. Chem., 37, 2029, 1991.
179. Keir, G., Winchester, B.G., and Clayton, P., Carbohydrate-deficient glycoprotein syndromes: inborn errors of protein glycosylation, Ann. Clin. Biochem., 36, 20, 1999.
180. Whitfield, J.B., Transferrin isoform analysis for the diagnosis and management of hazardous or dependent drinking, Clin. Chem., 48, 2095, 2002.
181. Stibler, H. and Kjellin, KG., Isoelectric-focusing and electrophoresis of CSF proteins in tremor of different origins-Study of 38 cases with cerebellar syndrome of chronic-alcoholism, Parkinson’s-disease and essential tremor, J. Neurol. Sci., 30, 269, 1976.
182. Stibler, H. et al., Abnormal microheterogeneity of transferrin in serum and cerebrospinal-fluid in alcoholism, Acta Med. Scand., 204, 49, 1978.
183. Stibler, H., Borg, S., and Allgulander, C., Clinical significance of abnormal heterogeneity of transferrin in relation to alcohol-consumption, Acta Med. Scand., 206, 275, 1979.
184. Wuyts, B. and Delanghe, J.R., The analysis of carbohydrate-deficient transferrin, marker of chronic alcoholism, using capillary electrophoresis, Clin. Chem. Lab. Med., 41, 739, 2003.
185. Lanz, C. et al., Evaluation and optimization of capillary zone electrophoresis with different dynamic capillary coatings for the determination of carbohydrate-deficient transferrin in human serum, J. Chromatogr. A, 979, 43, 2002.
186. Helander, A. et al., Interference of transferrin isoform types with carbohydrate-deficient transferrin quantification in the identification of alcohol abuse, Clin. Chem., 47, 1225, 2001.
187. Bortolotti, F. et al., Analysis of carbohydrate-deficient transferrin: Comparative evaluation of turbidimetric immunoassay, capillary zone electrophoresis, and HPLC, Clin. Chem., 51, 2368, 2005.
188. Jeppsson, J.-O., Kristensson, H., and Fimiani, C., Carbohydrate-deficient transferrin quantified by HPLC to determine heavy consumption of alcohol, Clin. Chem., 39, 2115, 1993.
189. Turpeinen, U. et al., Comparison of HPLC and small column (CDTect) methods for disialotransferrin, Clin. Chem., 47, 1782, 2001.
190. Helander, A., Husa, A., and Jeppsson, J.-O., Improved HPLC method for carbohydrate-deficient transferrin in serum, Clin. Chem., 49, 1881, 2003.
191. Prasad, R. et al., Analysis of carbohydrate deficient transferrin by capillary zone electrophoresis, Electrophoresis, 18, 1814, 1997.
192. Tagliaro, F. et al., Optimized determination of carbohydrate-deficient transferrin isoforms in serum by capillary zone electrophoresis, Electrophoresis, 19, 3033, 1998.
193. Crivellente, F. et al., Improved method for carbohydrate-deficient transferrin determination in human serum by capillary zone electrophoresis, J. Chromatogr. B, 739, 81, 2000.
194. Trout, A.L. et al., Direct capillary electrophoretic detection of carbohydrate-deficient transferrin in neat serum, Electrophoresis, 21, 2376, 2000.
195. Ramdani, B. et al., Analyte comigrating with trisialotransferrin during capillary zone electrophoresis of sera from patients with cancer, Clin. Chem., 49, 1854, 2003.
196. Sanz-Nebot, V. et al., Characterization of human transferrin glycoforms by capillary electrophoresis and electrospray ionization mass spectrometry, J. Chromatogr. B, 798, 1, 2003.
197. Lanz, C. et al., Improved capillary electrophoresis method for the determination of carbohydratedeficient transferrin in patient sera, Electrophoresis, 25, 2309, 2004.
198. Martello, S. et al., Determination of carbohydrate deficient transferrin (CDT) with capillary electrophoresis: an inter laboratory comparison, Forensic Sci. Internat., 141, 153, 2004.
199. Carchon, H.A. et al., Diagnosis of congenital disorders of glycosylation by capillary zone electrophoresis of serum transferrin, Clin. Chem., 50, 101, 2004.
200. Tagliaro, F. et al., Carbohydrate-deficient transferrin determination revisited with capillary electrophoresis:A new biochemical marker of chronic alcohol abuse, J. Cap. Electrophor. Microchip Tech., 5, 137, 1999.
201. Fermo, I. et al., Capillary zone electrophoresis for determination of carbohydrate-deficient transferrin in huan serum, Electrophoresis, 25, 469, 2004.
202. Giordano, B.C. et al., Dynamically-coated capillaries allow for capillary electrophoretic resolution of transferrin sialoforms via direct analysis of human serum, J. Chromatogr. B, 742, 79, 2000.
203. Wuyts, B. et al., Determination of carbohydrate-deficient transferrin using capillary zone electrophoresis, Clin. Chem., 47, 247, 2001.
204. Tagliaro, F. et al., Caveats in carbohydrate-deficient transferrin determination, Clin. Chem., 48, 208, 2001.
205. Lanz, C. and Thormann, W., Capillary zone electrophoresis with a dynamic double coating for analysis of carbohydrate-deficient transferrin in human serum: Impact of resolution between disialo- and trisialotransferrin on reference limits, Electrophoresis, 24, 4272, 2003.
206. Vitala, K., Lähdesmäki, K., and Niemela, O., Comparison of the Axis % CDT TIA and the CDTect method as laboratory tests of alcohol abuse, Clin. Chem., 44, 1209, 1998.
207. Delanghe, J.R., Wuyts, B., and De Buyzere, M.L., Caveats in carbohydrate-deficient transferring determination-Response, Clin. Chem., 48, 209, 2002.
208. Marquardt, T. and Dencke, J., Congenital disorders of glycosylation: Review of their molecular bases, clinical presentations and specific therapies, Eur. J. Pediatr., 162, 359, 2003.
209. Fournier, T., Medjoubi-N, N., and Porquet, D., Alpha-1-acid glycoprotein, Biochim. Biophys. Acta, 1482, 157, 2000.
210. Duche, J.-C. et al., Expression of the genetic variants of human alpha-1-acid glycoprotein in cancer, Clin. Chem., 33, 197, 2000.
211. Mackiewicz, A. and Mackiewicz, K., Glycoforms of serum α1-acid glycoprotein as markers of inflammation and cancer, Glycoconj. J., 12, 241, 1995.
212. Hashimoto, S. et al., α1-Glycoprotein fucosylation as a marker of carcinoma progression and prognosis, Cancer, 101, 2825, 2004.
213. Kremmer, T. et al., Liquid chromatographic and mass spectrometric analysis of human serum acid alpha-1-glycoprotein, Biomed. Chromatogr., 18, 323, 2004.
214. Hrycaj, P. et al., Micoheterogeneity of alpha 1 acid glycoprotein in rheumatoid arthritis: Dependent on disease duration?, Ann. Rheum. Dis., 52, 138, 1993.
215. Elliott, M.A. et al., Investigation into the Concavalin A reactivity, fucosylation and oligosaccharide microheterogeneity of α1-acid glycoprotein expressed in the sera of patients with rheumatoid arthritis, J. Chromatogr. B, 688, 229, 1997.
216. Iijima, S. et al., Changes of α1-glycoprotein microheterogeneity in acute inflammation stages analyzed by isoelectric focusing using serum obtained postoperatively, Electrophoresis, 21, 753, 2000.
217. Higai, K. et al., Glycosylation of site-specific glycans of α1-acid glycoprotein and alterations in acute ad chronic inflammation, Biochim. Biophys. Acta, 1725, 128, 2005.
218. Higai, K. et al., Altered glycosylation of α1-acid glycoprotein in patients with inflammation and diabetes mellitus, Clin. Chim. Acta, 329, 117, 2003.
219. Kakehi, K. et al., Capillary electrophoresis of sialic acid-containing glycoprotein. Effect of the heterogeneity of carbohydrate chains on glycoform separation using an α1-acid glycoprotein as a model, Anal. Chem., 73, 2640, 2001.
220. Sei, K. et al., Collection of α1-acid glycoprotein molecular species by capillary electrophoresis and the analysis of their molecular masses and carbohydrate chains. Basic studies on the analysis of glycoprotein glycoforms, J. Chromatogr. A, 958, 273, 2002.
221. Hiroaka, A. et al., Charge microheterogeneity of the β-trace proteins (lipocalin-type prostaglandin D synthase) in the cerebrospinal fluid of patients with neurological disorders analyzed by capillary isoelectric focusing, Electrophoresis, 22, 3433, 2001.
222. Lilja, H., Biology of prostate-specific antigen, Urology, 62, 27, 2003.
223. Peracaula, R. et al., Altered glycosylation pattern allows the distinction between prostate-specific antigen (PSA) from normal and tumor origins, Glycobiology, 13, 457, 2003.
224. Guzman, N.A., Immunoaffinity capillary electrophoresis applications of clinical and pharmaceutical relevance, Anal. Bioanal. Chem., 378, 37, 2004.
225. Mao, X., Chu, I.K., and Lin B., Asheath-flow nanoelectrospray interface of microchip electrophoresis MS for glycoprotein and glycopeptide analysis, Electrophoresis, 27, 5059, 2006.