Summary
The understanding of the physicochemical properties of proteins in solution is required to understand the separations taking place in the capillary. For example, during isoelectric focusing, it is important to ensure the lack of protein precipitation during focusing and mobilization otherwise artifacts occur and the true resolution of charge variants is not achieved. Similarly, buffer conditions, including additives, composition of buffer, and pH can influence the resolution of product variants. With diligent efforts one can achieve desired separations. As knowledge of buffer conditions and use of these techniques increase, the methods will be improved.
MECC can be useful for the characterization of recombinant proteins and monoclonal antibodies. However, the relatively long analyte migration times may be a deterrent for routine use in quality control situations. Pharmaceutical companies will employ new techniques which provide advantages over current technology. CE has advantages in certain applications. Applications which use slab gel techniques, IEF and SDS-PAGE can be replaced by the CE methods for formulation development, characterization of charge isoforms, and for purity determinations. CZE and clEF can be used for rapid identity tests which do not require peptide mapping. CZE has a tremendous advantage in analyzing basic proteins, and CZE and CE-SDS can be used to quantify product in the presence of interfering excipients. It is the responsibility of the analytical chemist to determine applications which are appropriate for CE. It is apparent that these are currently being defined for the biotechnology industry, and the usage of CE should continue to increase.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
International Conference on Harmonization Topic Q6B: Guidance on Specifications: Test Procedures and Acceptance Critera for Biotechnological/Biological Products Federal Register 1999, 64, 44928.
Harris, R.J.; Kabakoff, B.; Macchi, F.; Shen, F.J.; Kwong, M.; Andya, J.D.; Shire, S.J.; Bjork, B.; Totpal, K.; Chen, A.B. Submitted for publication.
Boyd, P.N.; Lines, A.C.; Patel, A.K. Molec. Immunol. 1995, 32, 1311.
Smedsrod, B.; Einarsson, M.; Pertoft, H. Thromb. Haemostas. 1988, 59, 480.
Wittwer, A.J.; Howard, S.C.; Carr, L.S.; Harakas, N.K.; Feder, J.; Parekh, R.B.; Rudd, P.M.; Dwek, R.A.; Rademacher, T.W. Biochemistry 1989, 28, 7662.
Dolnik, V. Electrophoresis 1997, 18, 2353.
Dolnik, V. Electrophoresis 1999, 20, 3106.
Righetti, P.J.; Bossi, A.; Olivieri, E.; Gelfi, C. J. Biochem. Biophys. Methods 1999, 40, 1.
Wehr, T.; Zhu, M.; Rodriguez-Diaz, R. Methods in Enzymol. 1996, 270, 358.
Rodriguez-Diaz, R.; Wehr, T.; Zhu, M.; Electrophoresis 1997 18: 2134.
Guttman, A.; Electrophoresis 1996, 17, 1333.
Strege, M.A.; Lagu, A.L. J. Chromatogr. A 1997, 780, 285.
Denton, K.A.; Täte, S.A. J. Chromatogr. A. 1997, 697, 111.
Strege, M.A.; Lagu, A.L. Electrophoresis 1997, 18, 2343.
Lagu, A.L. Electrophoresis 1999, 20, 3145.
Krull, I.S.; Liu, X.; Dai, J.; Gendreau, C.; Li, G. J. Pharm. Biomed Anal. 1997, 16, 377.
Kakehi, A K.; Honda, S. J. Chromatogr. A 1996, 720, 377.
Pantazaki, A.; Taverna, M.; Vidal-Madjar, C. Anal. Chim. Acta 1999, 383, 137.
Wise, E.T.; Singh, N.; Hogan, B.L. J. Chromatogr. A. 1996, 746, 109.
Bergmann, J.; Jaehde, U.; Schunack, W. Electrophoresis 1998, 19, 305.
Wu, X.Z.; Hosaka, A.; Hobo, T. Anal. Chem. 1998, 70, 2081.
Corradini, D. J. Chromatogr. B 1997, 699, 221.
Allen, D.; Baffi, R.; Bausch, J.; Bongers, J.; Costello, M.; Dougherty, J.Jr.; Federici, M.; Garnick, R.; Peterson, S.; Riggins, R.; Sewerin, K.; Tuls, J. Biologicals, 1996, 24, 255.
Janini, G.M.; Issaq, H.J. This monograph.
Janini, G.M.; Metral, C.J.; Issaq, H.J.; Muschik, G.M. J. Chromatogr. A 1999, 848, 417.
Offord. R.E. Nature 1966, 211, 591.
Chen, J.; Fausnaugh-Pollitt, J. This monograph.
Verzola, B.; Gelfi, C.; Righetti, P.G. J. Chromatogr. A 2000, 868, 85.
Liu, X.; Sosic, Z.; Krull, I.S. J. Chromatogr. A 1996, 735, 165.
Conti, M.; Galassi, M.; Bossi. A.; Righetti, P.G. J. Chromatogr. A 1997, 757, 237.
Tran, N.T.; Taverna, M.; Chevalier, M.; Ferrier, D. J. Chromatogr. A 2000, 866, 121.
Wehr, T.; Rodriguez-Diaz, R.; Zhu, M. This monograph.
Ferguson, K.A. Metab. Clin. Exp. 1964, 13, 985.
Schenerman, M.A.; Bowen, S.H. This monograph.
Strege, M.A.; Lagu, A.L. Anal. Biochem. 1993, 210, 402.
Eriksen, J.; Holm, K.A. J. Cap Elec. 1996, 3, 37.
James, D.C.; Freedman, R.B.; Hoare, M.; Jenkins, J. Anal. Biochem. 1994, 222, 315.
Kats, M.; Richberg, P.C.; Hughes, D.E. Anal. Chem. 1995, 67, 2943.
Miksik, I.; Deyl, Z. J. Chromatogr. A 1999, 852, 325.
Nashabeh, W.; Grieve, K.F.; Kirby, D.; Foret, F.; Karger, B.L. Anal. Chem. 1994, 66, 2148.
Kalman, F.; Ma, S.; Fox, R.O.; Horvath, C. J Chromatogr. A 1995, 705, 135.
Rudd, P.; Joao, H.C.; Coghill, E.; Fiten, P.; Saunders, M.R.; Opdenakker, G.; Dwek, R.A. Biochemistry 1994, 33, 17.
Watson, E.; Yao, F. Anal. Biochem. 1993, 210, 389.
Watson, E.; Yao, F. J. Chromatogr. A 1993, 630, 442.
Klausen, N.K.; Kornfelt, T. J. Chromatogr. A 1995, 718, 195.
Yim, K.; Abrams, J.; Hsu, A. J Chromatogr. A 1995, 716, 401.
Nielsen, R.G.; Riggin, R.M.; Rickard, E.C. J Chromatogr. 1989, 480, 393.
Cifuentes, A.; Poppe, H. Electrophoresis 1995, 16, 516.
Chen, A.B.; Rickel, C.A.; Flanigan, A.; Hunt, G.; Moorhouse, K.G. J Chromatogr. A 1996, 744, 279.
Kubach, J.; Grimm, R. J. Chromatogr. A 1996, 737, 281.
Thorne, J.M.; Goetzinger, W.K.; Chen, A.B.; Moorhouse, K.G.; Karger, B.L. J. Chromatogr. A 1996, 744, 155.
Frenz, J.F.; Wu, S.; Hancock, W.S. J Chromatogr. A 1989, 480, 379.
Rush, R.S.; Derby, P.L.; Strickland, T.W.; Rohde, M.F. Anal. Chem. 1993, 65, 1834.
Yowell, G.G.; Fazio, S.D.; Vivilecchia, R.V. J. Chromatogr. A 1993 652, 215.
Moorhouse, K.G.; Rickel, C.A.; Chen, A.B. Electrophoresis 1996, 17, 423.
Hunt, G.; Moorhouse, K.G.; Chen, A.B. J. Chromatogr. A 1996, 744, 295.
McNerney, T.M.; Watson, S.K.; Sim, J.-H.; Bridenbaugh, R.L. J. Chromatogr. A 1996, 744, 223.
Klyushnichenko, V.; Tishkov, V.; Kula, M.-R. J. Biotechnology 1997, 58, 187.
Goldman, M.H.; James, D.C.; Rendall, M.; Ison, A.P.; Hoare, M. AT Bull Biotech and Bioengineer. 1998, 60, 596.
Cifuentes, A.; Moreno-Arribas, M.V.; De Frutos, M.; Diez-Masa, J.C J. Chromatogr. A 1999, 830, 453.
Bietlot. H.P.; Girard, M. J. Chromatogr. A 1991, 759, 177.
Girard, M.; Bietlot, H.P.; Cyr, T.D. J. Chromatogr. A 1997, 772, 235.
Zhou, G.-H.; Luo, G.-A.; Zhou, Y.; Zhou, K.-Y.; Zhang, X.-D.; Huang, L.-Q. Electrophoresis 1998, 19, 2348.
Farchaus, J.W.; Ribot, W.J.; Jendrek, S.; Little, S.F. Appl. Environ. Micrbiol. 1998, 64, 982.
Roddy, T.R.; Molnar, T.E.; McKean, R.E.; Foley, J.P. J. Chromatogr. B 1997, 695, 49.
Silverman, C.; Komar, M.; Shields, K.; Diegnan, G.; Adamovics, J. J. Liquid Chrom. 1992, 15, 207.
Pritchett, T.; Evangelista, R.A.; Chen, F.-T.A. Bio/Tech 1995, 13, 1449.
Guzman, N.A.; Moschera, J.; Iqbal, K.; Malick, A.W. J. Chromatogr. A 1992, 608, 197.
Lee, H.G. J. Immunol. Methods 2000, 234, 71
Tsuji, K.; Little, R.J. J. Chromatogr. A 1992, 594, 317.
Knuver-Hopf, J.; Mohr, H. J. Chromatogr. A 1995, 717, 71.
Jorgensen, T.K.; Bagger, L.H.; Christiansen, J.; Johnsen, G.H.; Faarbaek, J.R.; Jorgensen, L.; Welinder, B.S. J. Chromatogr. A 1998, 817, 205.
Arcelloni, C.; Falqui, L.; Martinenghi, S.; Pontiroli, A.E.; Paroni, R. Electrophoresis 1998, 19, 1475.
Tran, A.; Parker, H.; Levi, V.; Kunitani, M. Anal. Chem. 1998, 70, 3809.
Jochheim, C.; Novick, S.; Balland, A.; Mahan-Boyce, J.; Wang, W.-C.; Goetze, A.; Gombotz, W. This Monograph.
Vo, H.C.; Britz-Mckibbin, P.; Chen, D.D.Y.; MacGillivray, R.T.A. FEBS Lett. 1999, 445, 256.
Somerville, L.E.; Douglas, A.J.; Irvine, A.E. J. Chromatogr. B 1999, 732, 81.
Kinoshita, M.; Murakami, E.; Oda, Y.; Funakubo, T.; Kawakami, D.; Kakehi, K.; Kawasaki, N.; Morimoto, K.; Hayakawa, T. J. Chromatogr. A 2000, 866, 261.
Oefner, C.; Suck, D. J. Mol. Biol. 1986, 192, 605.
Feiten, C.; Quan, C.P.; Chen, A.B.; Canova-Davis, E.; McNerney, T.; Goetzinger, W.K.; Karger, B.L. J Chromatogr. A 1999, 853, 295.
Quan, C.P.; Canova-Davis, E.; Chen, A.B. This monograph.
Ma, S.; Nashabeh, W. This monograph.
Hoffstetter-Kuhn, S.; Alt, G.; Kuhn, R. Electrophoresis 1996, 17, 418.
Santora, L.C.; Krull, I.S.; Grant, K. Anal. Biochem. 1999, 275, 98.
Hagmann, M.-L.; Kionka, C.; Schreiner, M.; Schwer, C. J. Chromatogr. A 1998, 816, 49.
Tang, S.; Nesta, D.P.; Maneri, L.R.; Anumula, K.R. J. Pharm. and Biomed. Anal. 1999, 19, 569.
McIntosh, K.A.; Charman, W.N.; Charman, S.A. J. Pharm. and Biomed. Anal. 1998, 16, 1097.
Gysler, J.; Mazereeuw, M.; Helk, B.; Heitzmann, M.; Jaehde, U.; Schunack, W.; Tjaden, U.R.; van der Greef, J. J. Chromatogr. A 1999, 841, 63.
Gysler, J.; Helk, B.; Dambacher, S.; Tjaden, U.R.; van der Greef, J. Pharm. Res. 1999, 16, 695.
Rochu, D.; Ducret, G.; Masson, P. J. Chromatogr. A 1999, 838, 157.
Rochu, D.; Ducret, G.; Ribes, F.; Vanin, S.; Masson, P. Electrophoresis 1999, 20, 1586.
Stellwagen, E.; Gelfi, C.; Righetti, P.G. J. Chromatogr. A 1999, 838, 131.
Facchetti, I. Biomedical Chromatogr. 1998, 12,138.
Salvi, A.; Carrupt, P.-A.; Testa, B. Helvetica Chimica Acta 1999, 82, 870.
Park, S.S.; Sloey, C.J.; Chang, B.S. This monograph.
Dupin, P.; Galinou, F.; Bayol, A. J Chromatogr. A 1995, 707, 396.
Hunt, G.; Nashabeh, W. Anal. Chem. 1999, 71, 2390.
Chen, J.; Fausnaugh-Pollitt, J.; Gu, L. J Chromatogr. A 1999, 853, 197
Hunt, G.; Hotaling, T.; Chen, A.B. J Chromatogr. A 1998, 800, 355.
International Conference on Harmonization Topic Q2B: Guideline on the validation of analytical procedures: methodology Federal Register 1997, 62, 27464.
Ma, S.; Nashabeh, W. Anal. Chem. 1999, 71, 5185.
Yeung, B.; Porter, T.J.; Vath, J.E. Anal Chem. 1997, 69, 2510.
Boss, H.J.; Watson, D.B.; Rush, R.S. Electrophoresis 1998, 19, 2654.
Liu, T.; Shao, X.-X.; Zeng, R.; Xia, Q.-C. 47 J. Chromatogr. A 1999, 855, 695.
Tong, W.; Yates, J.R. This monograph.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2001 Friedr. Vieweg & Sohn Verlagsgesellschaft mbH, Braunschweig/Wiesbaden
About this chapter
Cite this chapter
Chen, A.B., Canova-Davis, E. (2001). Capillary Electrophoresis in the Development of Recombinant Protein Biopharmaceuticals. In: Chen, A.B., Nashabeh, W., Wehr, T. (eds) CE in Biotechnology: Practical Applications for Protein and Peptide Analyses. Chromatographia CE Series, vol 5. Vieweg+Teubner Verlag. https://doi.org/10.1007/978-3-322-83021-0_1
Download citation
DOI: https://doi.org/10.1007/978-3-322-83021-0_1
Publisher Name: Vieweg+Teubner Verlag
Print ISBN: 978-3-322-83023-4
Online ISBN: 978-3-322-83021-0
eBook Packages: Springer Book Archive