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Formulation of Biologics Including Biopharmaceutical Considerations

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Pharmaceutical Biotechnology

Abstract

This chapter describes the various issues a formulator of biologics faces when turning an active pharmaceutical ingredient (API) into a biopharmaceutical product that can be administered to a patient. A well-equipped analytical lab to characterize chemical and physical characteristics of the protein in the formulation process is a first requirement. Then, the proper excipients and conditions (e.g., freeze-dried or not; refrigerated or not) to achieve an acceptable shelf-life of the formulated protein can be selected. Throughout this process one should consider the specific requirements linked to the desired route of administration, e.g., dose, volume, primary container. Alternative routes of administration are briefly discussed and their limitations listed.

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Author information

Authors and Affiliations

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

    Daan J. A. Crommelin

  2. Coriolis Pharma, Martinsried, Germany

    Andrea Hawe

  3. Division of BioTherapeutics, Leiden Academic Centre for Drug Research (LACDR), Leiden University, Leiden, The Netherlands

    Wim Jiskoot

Authors
  1. Daan J. A. Crommelin
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  2. Andrea Hawe
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  3. Wim Jiskoot
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Corresponding author

Correspondence to Daan J. A. Crommelin .

Editor information

Editors and Affiliations

  1. Utrecht University, Utrecht, The Netherlands

    Daan J. A. Crommelin

  2. Faculty of Pharmaceutical Sciences and The Centre for Health Evaluation & Outcomes Sciences (CHEOS), The University of British Columbia (UBC), Vancouver, BC, Canada

    Robert D. Sindelar

  3. College of Pharmacy, University of Tennessee, Health Science Center, Memphis, TN, USA

    Bernd Meibohm

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Crommelin, D.J.A., Hawe, A., Jiskoot, W. (2019). Formulation of Biologics Including Biopharmaceutical Considerations. In: Crommelin, D., Sindelar, R., Meibohm, B. (eds) Pharmaceutical Biotechnology. Springer, Cham. https://doi.org/10.1007/978-3-030-00710-2_5

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