Abstract
The first therapeutic proteins produced by fermentation of genetically engineered bacteria emerged two decades ago. With the notable exception of insulin, most of the initial wave of biotechnology products launched in the 1980s and 1990s were peptide hormones and enzymes licensed for indications with relatively small patient populations and for short-term rather than chronic use. Consequently, the market requirement for these products was frequently in the low kilogram range.
This is a preview of subscription content, log in via an institution to check access.
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
Aoyama, K., Chiba, J., (1993) Separation of different molecular forms of Mouse IgA and IgM monoclonal antibodies by High-performance liquid chromatography on spherical hydroxyapatite beads. J. Immunol.methods 162, pp 201–210
Boschetti, E., (2001) The use of thiophilic chromatography for antibody purification: a review, Journal of Biochemical and Biophysical Methods, 49, pp 361–389
Boschetti, E., (2002) Antibody separation by hydrophobic charge induction chromatography, Trends in Biotechnology, 20, pp 333–337
Brorson, K., Brown, J., Hamilton, E., Stein, K.E., (2003) Identification of protein A media performance attributes that can be monitored as surrogates for retrovirus clearance during extended re-use, J. Chromatog. A, 989, pp 155–163
Christy, C., Adams, G,. Kuriyel, R., Bolton, G., Scilly, A., (2002). High-performance tangential flow filtration: a highly selective membrane separation process, Desalination, 144, pp 133–136
Ehrlich, G.K., Bailon, P., (2001) Identification of model peptides as affinity ligands for the purification of humanized monoclonal antibodies by means of phage display, Journal of Biochemical and Biophysical Methods, 49, pp443–454
Fahrner, R., Iyer, H.V., Blank, G.S., (1999a) The optimal Flow Rate and Column Length for maximal Production rate of Protein A Affinity Chromatography. Bioprocess Engineering, 21 pp287–292
Fahrner, R., Whitney, D.H., Vanderlaan, M., Blank, G.S., (1999b) Performance Comparison of Protein A Affinity Chromatography Sorbents for Purifying Recombinant Monoclonal Antibodies. Biotechnol. Appl. Biochem. 30 ppl21–128
Fahrner, R.L., Blank, G.S., Zapata, G.A., (1999c) Expanded bed protein A affinity chromatography of a recombinant humanized monoclonal antibody: process development, operation, and comparison with a packed bed method, J. Biotech., 75, pp273–280
Fernandez-Lahore, H,M,. Geilenkirchen, S., Boldt, K., Nagel, A., Kula, M.-R., Thömmes, J., (2000) The influence of cell adsorbent interactions on protein adsorption in expanded beds, J. Chromatog. A, 873, pp 195–208
Feuser, J., Halfar, M., Lütkemeyer, D., Ameskamp, N., Kula, M.-R., Thömmes, J., (1999) Interaction of mammalian cell culture broth with adsorbents in expanded bed adsorption of monoclonal antibodies, Process Biochemistry, 34, pp 159–165
Fuglistaller, P. (1989) Comparison of immunoglobulin binding capacities and ligand leakage using eight different protein A affinity chromatography matrices. J. Immunol. Methods, 124, pp. 171–177.
Gagnon, P. (1996) Purification tools for monoclonal antibodies. Validated Biosystems, Tucson, Arizona
Graille, M., Stura, E.A., Housden, N.G., Beckingham, J.A., Bottomley, S.P., Beale, D., Taussig, M.J., Sutton, B.J., Gore, M.G., Charbonnier, J-B. (2001) Complex between Peptostreptococcus magnus Protein L and a Human Antibody Reveals Structural Convergence in the Interaction Modes of Fab Binding Proteins, Structure, 9, pp 679–687
Güilich, S., Linhult, M., Nygren, P-A., Uhlén, M., Hober, S. (2000) Stability towards alkaline conditions can be engineered into a protein ligand, J. Biotechnol, 80, pp 169–178
Harris, L.J., Skaletski, E., McPherson, A., (1995) Crystallization of Monoclonal antibodies. Proteins: Struct. Fund. Genet. 23: pp285–289
Iyer, H., Henderson, F., Cunningham, E., Webb, J., Hanson, J., Bork, C., Conley, L. (2002) Considerations during development of a Protein A based antibody purification process. Biopharm Jan 2002 pp 14–20
Kamiya, Y., Majima, T., Sohma, Y., Katoh, S. and Sada, E. (1990). Effective purification of bioproducts by fast flow affinity chromatography. J. Ferment. Bioeng. 695, pp. 298–301
Kemp, G., Hamilton, G., Mann, A.F., O’Neil, P. (2001) Increasing Throughput in Affinity Applications by Increasing Bed Height — An Alternative Approach to Process Scale-up. Poster presentation IBC Conference on Antibody Engineering, Feb 2001, San Diego.
McCue, J.T., Kemp, G.D., Low, D., Garcia, I.Q. (2003) Evaluation of Protein A Chromatography Media J.Chromatog. A 989 ppl39–153
Malmquist, G., Lindberg, U., Bergenstrahle A., Lindahl, P. (2000) Differences in the effect of sample residence time on the dynamic binding capacity of Protein A Media. Poster presentation GAb2000, Barcelona
van Reis, R., Leonard, L.C., Hsu, C.C., Builder, S.E. (1991). Industrial scale harvest of proteins from mammalian cell culture by tangential flow filtration. Biotechnol. Bioeng. 38, pp. 413–422.
van Reis, R., Brake, J.M., Charkoudian. J., Burns. D.B., Zydney. A.L. (1999) High-performance tangential flow filtration using charged membranes, Journal of Membrane Science, 159, pp 133–142
Thömmes, J., Bader, A., Halfar, M., Karau, A. Kula, M-R. (1996) Isolation of monoclonal antibodies from cell containing hybridoma broth using a protein A coated adsorbent in expanded beds, J. Chromatogr. A, 752, pp 111–122
Schwartz, W., Judd, D., Wysocki M., Guerrier, L., Birck-Wilson E., Boschetti. E. (2001) Comparison of hydrophobic charge induction chromatography with affinity chromatography on protein A for harvest and purification of antibodies, J. Chromatogr. A, 908, pp 251–263
Stapleton, A., Zhang, X., Petrie, H., Machamer, J.E. (1996) Evaluation of different approaches for the Chromatographic purification of monoclonal antibodies. Tech Note 2026. BioRad Laboratories
Sulkowski, E. (1987) Controlled pore glass chromatography of proteins: Protein purification micro to macro; Proceedings of a Cetus-UCLA symposium. Richard Burgess, New York AR Liss,Vol 68 pp l77–195
Visuri, K. ((2002) Potential use of crystallisation in purification of antibodies, 8 th International Antibody Production and Downstream Processing conference, San Diego CA
Yamamoto, S., Sano, Y. (1992) Short cut method for predicting the productivity of affinity chromatography. J. Chromatogr. 597 ppl73–179
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2004 Springer Science+Business Media New York
About this chapter
Cite this chapter
Kemp, G., O’Neil, P. (2004). Large-Scale Production of Therapeutic Antibodies: Considerations for Optimizing Product Capture and Purification. In: Subramanian, G. (eds) Antibodies. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-8875-1_3
Download citation
DOI: https://doi.org/10.1007/978-1-4419-8875-1_3
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4613-4701-9
Online ISBN: 978-1-4419-8875-1
eBook Packages: Springer Book Archive