Abstracts
Purified proteins have been used as human medicines for many decades. Before recombinant DNA technology was developed, hormones (e.g., insulin and human growth hormone) and other proteins were extracted and purified from blood and other tissues. Because of the low levels of the protein of interest in the tissues, the purification was technically very difficult and often it was more of an “enrichment” than a purification to homogeneity. Since the 1970s, the ability to genetically engineer Escherichia coli and other organisms to produce large quantities of therapeutically interesting molecules has led to the development of dozens of therapeutic proteins (1). Some of these proteins (e.g., erythropoetin) are hugely successful drugs with annual worldwide sales of several billion dollars (2).
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
References
Birch, J. R. (1997) Review of Biotechnology-derived products in use and in development. Eur. J. Parenteral Sci. 2(3), 3–10.
Ramakrishnan, A. and Sadana, A. (2000) Economics of bioseparation processes, in Handbook of Bioseparations (Ahuja, S., ed.), Academic, New York, pp. 667–685.
Medicines Control Agency (2002) Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002, The Stationery Office, London.
Sofer, G. and Zabriskie, D. W. (eds.) (2000) Biopharmaceutical Process Validation, Marcel Dekker, New York.
O’Keefe, D. O. (2000) Analysis of protein impurities in pharmaceuticals derived from recombinant DNA, in Handbook of Bioseparations (Ahuja, S., ed.), Academic, New York, pp. 23–70.
O–Leary, R. M., Feuerhelm, D., Peers, D., Xu, Y., and Blank, G. S. (2001) Determining the useful lifetime of chromatography resins: prospective small-scale studies. BioPharm 14(9), 10–18.
Kelly, B. D., Jennings, P., Wright, R., and Briasco, C. (1997) Demonstrating process robustness for chromatographic purification of a recombinant protein. BioPharm 10(10), 36–47.
Wisniewski, R., Boschetti, E., and Jungbauer, A., (1996) Process considerations for largesale chromatography of biomolecules, in Biotechnology and Biopharmaceutical Manufacturing, Processing and Preservation (Avis, K. E. and Wu, V. L., eds.), HIS Healthcare Group, Englewood, CO.
Roberts, P. (1996) Efficient removal of viruses by a novel polyvinylidene fluoride membrane filter. J. Vi rol. Methods 65, 27–31.
Darling, A. J. (2000) Validation of the purification process for viral clearance, in Biopharmaceutical Process Validation (Sofer, G. and Zabriskie, D. W., eds.), Marcel Dekker, New York, pp.157–196.
The European Agency for the Evaluation of Medicinal Products CPMP Biotechnology Working Party (1997) Notes for Guidance on Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell lines of Human or Animal Origin, CPMP/ICH/295/95
Sherwood, D. (2000) Cleaning: multiuse facility issues, in Biopharmaceutical Process Validation (Sofer, G. and Zabriskie, D. W., eds.), Marcel Dekker, New York, pp. 235–249.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2004 Humana Press Inc., Totowa, NJ
About this protocol
Cite this protocol
Bonnerjea, J. (2004). Purification of Therapeutic Proteins. In: Cutler, P. (eds) Protein Purification Protocols. Methods in Molecular Biology, vol 244. Humana Press. https://doi.org/10.1385/1-59259-655-X:455
Download citation
DOI: https://doi.org/10.1385/1-59259-655-X:455
Publisher Name: Humana Press
Print ISBN: 978-1-58829-067-0
Online ISBN: 978-1-59259-655-3
eBook Packages: Springer Protocols