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Introduction into Novel Constructs

  • Susanne Joerg
  • Kapil Gupta
  • Margarida Rodrigues
Chapter
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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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Susanne Joerg
    • 1
    • 3
  • Kapil Gupta
    • 2
  • Margarida Rodrigues
    • 1
  1. 1.Biologics Process Research and Development, Early Phase Development, Pharmaceutical DevelopmentNovartis Pharma AGBaselSwitzerland
  2. 2.Biologics Process Research and Development, Integrated Biologics ProfilingNovartis Pharma AGBaselSwitzerland
  3. 3.Pharma and Biotech Drug Product ServicesLonza AGBaselSwitzerland

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