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Principles of Biopharmaceutical Protein Formulation

An Overview

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Therapeutic Proteins

Part of the book series: Methods in Molecular Biology™ ((MIMB,volume 308))

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Abstract

Ideally, formulation development of biopharmaceutical protein therapeutics will provide a final dosage form that offers sufficient ex vivo stability during processing, handling, and long-term storage and also provide adequate in vivo stability in terms of bioavailability that meets the pharmacokinetics/pharmacodynamics (PK/PD) therapeutic requirements. This chapter focuses on ex vivo stability of protein therapeutics and is targeted for the novice researcher who struggles with the inherent instabilities of biological molecules. More important, this chapter provides the inexperienced formulators with fundamental understanding and the basic tools for formulation development of biopharmaceutical proteins.

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Authors and Affiliations

  1. ALZA Corporation, Mountain View, CA

    Scott P. Sellers & Yuh-Fun Maa

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  1. Scott P. Sellers
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  2. Yuh-Fun Maa
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Editor information

Editors and Affiliations

  1. Protein Science Group, Department of Biosciences, University of Kent, Canterbury, Kent, UK

    C. Mark Smales

  2. School of Engineering, University of Queensland, St. Lucia, Queensland, Australia

    David C. James

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© 2005 Humana Press Inc.

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Sellers, S.P., Maa, YF. (2005). Principles of Biopharmaceutical Protein Formulation. In: Smales, C.M., James, D.C. (eds) Therapeutic Proteins. Methods in Molecular Biology™, vol 308. Humana Press. https://doi.org/10.1385/1-59259-922-2:243

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  • DOI: https://doi.org/10.1385/1-59259-922-2:243

  • Publisher Name: Humana Press

  • Print ISBN: 978-1-58829-390-9

  • Online ISBN: 978-1-59259-922-6

  • eBook Packages: Springer Protocols

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