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Pharmaceutical Biotechnology pp 19–45Cite as

Biophysical and Biochemical Analysis of Recombinant Proteins

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Abstract

For a recombinant protein to become a human therapeutic, its biophysical and biochemical characteristics must be well understood. These properties serve as a basis for comparison of lot-to-lot reproducibility; for establishing the range of conditions to stabilize the protein during production, storage, and shipping; and for identifying characteristics useful for monitoring stability during long-term storage.

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Further Reading

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  • Jiskoot W, Crommelin DJA (eds) (2005) Methods for structural analysis of protein pharmaceuticals. AAPS Press, Arlington

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  • Landus JP (ed) (1994) Handbook of capillary electrophoresis. CRC Press, Boca Raton

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  • McEwen CN, Larsen BS (eds) (1990) Mass spectrometry of biological materials. Dekker, New York

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  • Price CP, Newman DJ (eds) (1991) Principles and practice of immunoassay. Stockton, New York

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Author information

Authors and Affiliations

  1. Department of Protein Chemistry, Alliance Protein Laboratories, 3957 Corte Cancion, Thousand Oaks, CA, 91360, USA

    Tsutomu Arakawa Ph.D.

  2. Department of Biophysical Chemistry, Alliance Protein Laboratories, 3957 Corte Cancion, Thousand Oaks, CA, 91360, USA

    John S. Philo Ph.D.

Authors
  1. Tsutomu Arakawa Ph.D.
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  2. John S. Philo Ph.D.
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Corresponding author

Correspondence to Tsutomu Arakawa Ph.D. .

Editor information

Editors and Affiliations

  1. Department of Pharmaceutical Sciences, Utrecht University, Utrecht, Utrecht, The Netherlands

    Daan J. A. Crommelin

  2. Department of Pharmaceutical Sciences and Department of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada

    Robert D. Sindelar

  3. Department of Pharmaceutical Sciences, University of Tennessee Health Science Center, College of Pharmacy, Memphis, Tennessee, USA

    Bernd Meibohm

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© 2013 Springer Science+Business Media New York

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Arakawa, T., Philo, J.S. (2013). Biophysical and Biochemical Analysis of Recombinant Proteins. In: Crommelin, D., Sindelar, R., Meibohm, B. (eds) Pharmaceutical Biotechnology. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-6486-0_2

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