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Formulation of Biologics Including Biopharmaceutical Considerations

  • Daan J. A. CrommelinEmail author
  • Andrea Hawe
  • Wim Jiskoot
Chapter

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.

Keywords

Formulation Dosage form Stability-shelf life Route of administration Excipients Delivery 

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Further Reading

  1. Carpenter JF, Manning MC (2002) Rational design of stable protein formulations–theory and practice. Kluwer Academic/Plenum, New YorkCrossRefGoogle Scholar
  2. Mahler H-C, Jiskoot W (2012) Analysis of aggregates and particles in protein pharmaceuticals. Wiley, HobokenCrossRefGoogle Scholar
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  4. Manning MC, Liu J, Li T, Holcomb RE (2018) Rational design of liquid formulations of proteins. Adv Protein Chem Struct Biol 112:1–59CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Daan J. A. Crommelin
    • 1
    Email author
  • Andrea Hawe
    • 2
  • Wim Jiskoot
    • 3
  1. 1.Department of Pharmaceutical, Utrecht Institute for Pharmaceutical SciencesUtrecht UniversityUtrechtThe Netherlands
  2. 2.Coriolis PharmaMartinsriedGermany
  3. 3.Division of BioTherapeutics, Leiden Academic Centre for Drug Research (LACDR)Leiden UniversityLeidenThe Netherlands

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