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Large-scale column chromatography — a GMP manufacturing perspective

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Handbook of Downstream Processing

Abstract

During the past decade the biotechnology industry has used process-scale chromatography operations as the primary method of protein purification. This critical unit operation continues to be the main focus of purification development teams as an ever increasing number of biopharmaceuticals are commercialized. Consequently, consideration of column chromatography scale-up and manufacturing issues is a critial element in the successful commercialization of therapeutic proteins.

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Further reading

  • Courtney McGregor, W. (Ed.), (1986). Membrane Separations in — Biotechnology. Marcel Dekker, New York.

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  • Deutscher, M. (Ed.), (1990). Methods of Enzymology, Vol. 182, Guide for Protein Purification, Academic Press, London.

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  • Fiechter, A. (Ed.) (1982). Advances in Biochemical Engineering. Springer-Verlag, New York.

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  • LeRoth, D., Shiloach, J. and Leahy, T. (1985). Purification of Fermentation. American Chemical Society.

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  • Nauch, D. (1990). Industrial-scale downstream processing of biotechnology products. Bio Pharm May.

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  • Scopes, R.J. (1987). Protein Purification Principles and Practices, 2nd edn. Springer-Verlag, New York.

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  • Sofer, G.K. and Nystrom, L.E. (1989). Process Chromatography: A Practical Guide. Academic Press, San Diego, California.

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  • Via, J.W., Costs, D.W. and Reed, R. (1991). “Select the right sensors for pharmaceutical processes”, Chem. Eng. Prog.

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© 1997 Chapman & Hall

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Edwards, J. (1997). Large-scale column chromatography — a GMP manufacturing perspective. In: Goldberg, E. (eds) Handbook of Downstream Processing. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-1563-3_7

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  • DOI: https://doi.org/10.1007/978-94-009-1563-3_7

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-7198-7

  • Online ISBN: 978-94-009-1563-3

  • eBook Packages: Springer Book Archive

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