Regulatory and CMC considerations for next-generation antibody drug conjugates

ADCs are undergoing rapid diversification. While highly potent cytotoxic payloads largely define ADCs, the field is now expanding to include immune agonists, metabolic modulators, radio-conjugates, and other non-cytotoxic modalities. This evolution is opening new therapeutic opportunities, but it is also exposing gaps in existing regulatory frameworks and CMC strategies that were largely built around classical cytotoxic conjugates.

In this expert Q&A, Bioconjugate Insights brings together perspectives from industry leaders to explore whether current global regulatory guidance remains fit for purpose, how sponsors can navigate ambiguity across development and submission, and what lessons from earlier ADC generations should inform the next wave of innovation.

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