Overcoming DAR Variability From an Unspecified Raw Material Impurity
Time: 11:30 am
day: Day Two
Details:
- Case-study on out-of-specification DAR result during clinical manufacturing of ADC: Investigation uncovered an unspecified impurity within raw materials, capable of reacting with the drug-linker an impacting DAR.
- A mismatch between raw materials used in development and manufacturing accounted for the OOS, but subsequent batches yielded in-spec DAR but lower than expected.
- Follow up investigative work further highlighted the impact of this impurity on DAR, prompting process changes for more accurate analysis and control of the impurity during manufacturing.
