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“Fc Fusion Proteins”

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Challenges in Protein Product Development

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 38))

Abstract

IgG-based therapeutics has become an increasingly important category of the over two hundred biopharmaceutical products approved in the USA and the EU by late 2014. While a large percentage of this consists of monoclonal antibodies, Fc fusion proteins make up an important class of IgG-based biotechnology drugs. This chapter reviews the rationale for creating Fc fusion proteins , describes challenges, regulatory considerations, and improvements that have been made with this important class of therapeutics.

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Author information

Authors and Affiliations

  1. Process Development, Amgen, 1 Amgen Center Dr, Thousand Oaks, CA, 91320, USA

    Carole Heath

  2. Just Biotherapeutics, 401 Terry Ave N, Seattle, WA, 98109, USA

    Dean Pettit

Authors
  1. Carole Heath
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  2. Dean Pettit
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Correspondence to Dean Pettit .

Editor information

Editors and Affiliations

  1. BioTherapeutics Research and Development Pharmaceutics Research and Development, Pfizer Inc., Andover, Massachusetts, USA

    Nicholas W. Warne

  2. Lonza AG, Drug Product Services, Basel, Basel Stadt, Switzerland

    Hanns-Christian Mahler

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© 2018 American Association of Pharmaceutical Scientists

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Heath, C., Pettit, D. (2018). “Fc Fusion Proteins”. In: Warne, N., Mahler, HC. (eds) Challenges in Protein Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 38. Springer, Cham. https://doi.org/10.1007/978-3-319-90603-4_24

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