A Justified Limit for the Identification Threshold of Organic Impurities in Drug-Linker Intermediates Used to Produce Antibody-Drug Conjugates
2:02 pm - Tuesday 9th March 2027
- A science-based justification for D-L related impurities identification threshold
- Analysis of 47 ADCs data set to justify the proposal of related impurities identification threshold
- A convergence-of-evidence methodology. Rather than relying on a single argument, we applied four independent quantitative criteria and asked: at what impurity level are all four criteria satisfied for all 47 clinical-stage ADCs in our dataset
