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Switching from an IV to an SC Formulation—Considerations for Formulation Development and Formulation Bridging

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Challenges in Protein Product Development

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

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Abstract

Subcutaneous (SC) administration is one of the most common application routes for biologics besides intravenous infusion (IV) and represents a beneficial alternative to IV, as it may represent an increased patient convenience. However, several considerations need to be taken into account for successful development of SC products as will be outlined in the following chapter.

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Acknowledgements

We would like to thank Silke Mohl, Axel Boehnke, Sebastien Denis and Thomas Klein for providing helpful input during the review.

Author information

Authors and Affiliations

  1. Pharmaceutical Development and Supplies, PTD Biologics Europe (PTDE-P), F. Hoffmann-La Roche Ltd., Bldg. 72/347a, 4070, Basel, Switzerland

    Claudia Mueller

  2. Pharmaceutical Development and Supplies, PTD Biologics Europe (PTDE-P), F. Hoffmann-La Roche Ltd., Bldg. 72/318, 4070, Basel, Switzerland

    Michael Adler

Authors
  1. Claudia Mueller
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  2. Michael Adler
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Correspondence to Claudia Mueller .

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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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Mueller, C., Adler, M. (2018). Switching from an IV to an SC Formulation—Considerations for Formulation Development and Formulation Bridging. 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_26

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