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Challenges in Protein Product Development pp 497–526Cite as

Introduction into Novel Constructs

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

Abstract

New biologic molecules—such as mAb-derived formats, nanobodies, bispecifics, and fusion proteins —are quite diverse and come along with new formulation and process development challenges. The properties are very dependent on the molecule and difficult to generalize. Hence, only by selection of optimized formulation conditions it is ensured to keep challenging molecule properties under control. In addition, a variety of analytical methods needs to be applied to thoroughly investigate all critical quality attributes. Finally with regard to compatibility, appropriate experimental design that mimics clinical administration procedure is essential (including product in-use stability and stability during administration conditions) and creative solutions might be required to ensure clinical dosing. Thorough pharmaceutical development is key to enable integrity and stability of novel biologics compounds upon storage and administration .

Keywords

  • ADC
  • Bispecifics
  • Fusion proteins
  • Developability
  • Formulation

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Author information

Authors and Affiliations

  1. Biologics Process Research and Development, Early Phase Development, Pharmaceutical Development, Novartis Pharma AG, Basel, Switzerland

    Susanne Joerg & Margarida Rodrigues

  2. Biologics Process Research and Development, Integrated Biologics Profiling, Novartis Pharma AG, Basel, Switzerland

    Kapil Gupta

  3. Pharma and Biotech Drug Product Services, Lonza AG, Basel, Switzerland

    Susanne Joerg

Authors
  1. Susanne Joerg
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  2. Kapil Gupta
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  3. Margarida Rodrigues
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Corresponding author

Correspondence to Susanne Joerg .

Editor information

Editors and Affiliations

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

    Ph.D. Nicholas W. Warne

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

    Ph.D. Hanns-Christian Mahler

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Joerg, S., Gupta, K., Rodrigues, M. (2018). Introduction into Novel Constructs. 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_22

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