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Chapter 10: Analytical Methods for Antibody Drug Conjugate Characterization

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Book cover Development of Biopharmaceutical Drug-Device Products

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.

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Correspondence to Julie L. Heflin .

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Fischmann, S. et al. (2020). Chapter 10: Analytical Methods for Antibody Drug Conjugate Characterization. In: Jameel, F., Skoug, J., Nesbitt, R. (eds) Development of Biopharmaceutical Drug-Device Products. AAPS Advances in the Pharmaceutical Sciences Series, vol 35. Springer, Cham. https://doi.org/10.1007/978-3-030-31415-6_10

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