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Chapter 2: Challenges and Considerations in the Design of Antibody-Drug Conjugates

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Development of Biopharmaceutical Drug-Device Products

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 35))

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Abstract

Antibody-drug conjugates (ADCs) have emerged as a new class of anti-cancer drugs where the strengths of cytotoxic small molecules are combined with specificity/selectivity of antibodies to enhance the therapeutic efficacy and safety of the drug. All components that comprise the ADC come with liabilities, and their understanding is central to the successful development of an ADC. This chapter describes in detail the mechanism of action of ADCs, the capabilities/limitations of all the components of the molecule, and considerations for the conjugation process and drug-to-antibody ratio (DAR) and provides guidance with respect to the impact of ADC attributes on pharmacokinetics and pharmaceutical stability. Special reference has been made to the necessary considerations in designing formulations for ADCs.

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Authors and Affiliations

  1. Formulation Development, New Biological Entities, AbbVie (United States), North Chicago, IL, USA

    Feroz Jameel, Brittney J. Mills & Ehab M. Moussa

  2. AbbVie, North Chicago, IL, USA

    Vikram Sisodiya, Tony Cano & Anthony R. Haight

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  1. Feroz Jameel
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  2. Brittney J. Mills
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  3. Ehab M. Moussa
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  4. Vikram Sisodiya
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  5. Tony Cano
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  6. Anthony R. Haight
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Correspondence to Feroz Jameel .

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Editors and Affiliations

  1. Formulation Development New Biological Entities, AbbVie (United States), North Chicago, IL, USA

    Feroz Jameel

  2. Drug Product Development (Retired), AbbVie (United States), North Chicago, IL, USA

    John W. Skoug

  3. Combination Product Development, AbbVie, Inc., North Chicago, IL, USA

    Robert R. Nesbitt

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Jameel, F., Mills, B.J., Moussa, E.M., Sisodiya, V., Cano, T., Haight, A.R. (2020). Chapter 2: Challenges and Considerations in the Design of Antibody-Drug Conjugates. 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_2

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