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Chapter 10: Analytical Methods for Antibody Drug Conjugate Characterization

  • Stephanie Fischmann
  • Julie L. HeflinEmail author
  • Joseph Eschweiler
  • Beijing Huang
  • Maike Eisenkolb
  • Stephanie Katzenbach
  • Gregory Webster
Chapter
  • 69 Downloads
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)

Abstract

Antibody-drug conjugates (ADCs) are advance biologic molecules in which chemical drugs are bound to an antibody targeting a specific antigen on the surface of cells. ADCs are a new kind of therapeutic agents in the treatment of various cancers. As they are the combination of an antibody and a small molecule drug, they present unique challenges for analytical characterization. Attributes from both the small and large molecule components should be considered as quality attributes. This chapter will present the current approaches in analytical methodologies used for ADC characterization.

Keywords

Antibody-drug conjugate (ADC) Drug Linker Drug-linker Drug-to-antibody ratio (DAR) Higher-order structure (HOS) Targeted delivery Purity Potency Impurities 

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Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  • Stephanie Fischmann
    • 1
  • Julie L. Heflin
    • 2
    Email author
  • Joseph Eschweiler
    • 2
  • Beijing Huang
    • 2
  • Maike Eisenkolb
    • 1
  • Stephanie Katzenbach
    • 1
  • Gregory Webster
    • 2
  1. 1.NBE Analytical R&D-LU, Analytical R&D, AbbVie Deutschland GmbH & Co. KGKnollstrasseGermany
  2. 2.NBE Analytical R&D-LC, Analytical R&DAbbVie Inc North ChicagoUSA

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