A Justified Limit for the Identification Threshold of Organic Impurities in Drug-Linker Intermediates Used to Produce Antibody-Drug Conjugates
1:45 pm - Tuesday 9th March 2027
- Showcasing a science-based justification for D-L related impurities identification threshold
- Analysing a 47-ADC data set to justify the proposal of related impurities identification threshold
- Applying four independent quantitative criteria to address what impurity levels are all four criteria satisfied for all 47 clinical-stage ADCs in our dataset