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Characterization, Formulation, and Stability of Neupogen® (Filgrastim), a Recombinant Human Granulocyte-Colony Stimulating Factor

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Formulation, Characterization, and Stability of Protein Drugs: Case Histories

Part of the book series: Pharmaceutical Biotechnology ((PBIO,volume 9))

Conclusions

G-CSF is an extremely well-known and well-characterized molecule. Both the natural glycosylated form and the E. coli-produced nonglycosylated form are biologically active. A thorough understanding of the primary, secondary, and tertiary structures has enabled a rational approach to purification, folding, and formulation. Although the product can be considered mature, and testing and development of the second-generation formulation are complete, chemical and physical analysis of the product continue. It is this continued effort to understand the chemistry and stability of the product that ensure a safe and efficacious molecule.

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Author information

Authors and Affiliations

  1. Analytical Research and Development, Amgen Inc., Thousand Oaks, California, 91320, USA

    Alan C. Herman

  2. Process Science, Amgen Inc., Thousand Oaks, California, 91320, USA

    Thomas C. Boone

  3. Protein Structure, Amgen Inc., Thousand Oaks, California, 191320, USA

    Hsieng S. Lu

Authors
  1. Alan C. Herman
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  2. Thomas C. Boone
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  3. Hsieng S. Lu
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Editor information

Editors and Affiliations

  1. Megabios Corporation, Burlingame, California, USA

    Rodney Pearlman

  2. Scios Nova, Inc., Mountain View, California, USA

    Y. John Wang

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© 2002 Kluwer Academic Publishers

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Herman, A.C., Boone, T.C., Lu, H.S. (2002). Characterization, Formulation, and Stability of Neupogen® (Filgrastim), a Recombinant Human Granulocyte-Colony Stimulating Factor. In: Pearlman, R., Wang, Y.J. (eds) Formulation, Characterization, and Stability of Protein Drugs: Case Histories. Pharmaceutical Biotechnology, vol 9. Springer, Boston, MA. https://doi.org/10.1007/0-306-47452-2_7

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  • DOI: https://doi.org/10.1007/0-306-47452-2_7

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-0-306-45332-8

  • Online ISBN: 978-0-306-47452-1

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