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Antibody-drug conjugates (ADCs) link antibodies to cytotoxic payloads to enable targeted therapy. This paper reviews the evolution of ADC toxicology, including manufacturing considerations, health authority perspectives, preclinical testing strategies, and common toxicity findings. Early ADC development faced challenges due to instability and immunogenicity, but improved antibody and linker design has since widened therapeutic index. Currently ADCs are regulated similarly to biologics, requiring less testing of individual components; pivotal studies should evaluate safety of the intact ADC. As ADCs continue to be refined, ongoing dialogue with regulators regarding emerging science is recommended to ensure patient safety.

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Toxicology Considerations on Antibody-Drug Conjugate Discovery and Development

  • 章节

  • 发表日期：

    2026年

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  • Andrea Rodrigues,
  • Ali Chesney,
  • Amy Kimzey,
  • Brian Welsh,
  • Damon Demady

摘要

Antibody-drug conjugates (ADCs) link antibodies to cytotoxic payloads to enable targeted therapy. This paper reviews the evolution of ADC toxicology, including manufacturing considerations, health authority perspectives, preclinical testing strategies, and common toxicity findings. Early ADC development faced challenges due to instability and immunogenicity, but improved antibody and linker design has since widened therapeutic index. Currently ADCs are regulated similarly to biologics, requiring less testing of individual components; pivotal studies should evaluate safety of the intact ADC. As ADCs continue to be refined, ongoing dialogue with regulators regarding emerging science is recommended to ensure patient safety.