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Scientific Poster Download
Poster modified on 16/04/2026
Scientific Justification for an Appropriate Specification Limit of Residual Solvent Based on ICH Guideline
In the manufacturing of payload-linkers for antibody-drug conjugates (ADC), residual solvents may remain in payload-linker intermediates due to process limitations and physicochemical properties. In this scientific poster, we highlight,
- A risk‑based approach, aligned with ICH Q3C (R8), was applied to justify residual solvent limits at the ADC linker‑payload stage.
- Conservative exposure modeling incorporating PDE, ADC dose, stoichiometry, and clearance supports clinically acceptable intermediate‑level specifications.
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