Highlighting the Specific Critical Quality Attributes for an Acceptable ADC From a Regulatory Stance
Time: 9:00 am
day: Day One
Details:
- Overviewing the specific criteria required by regulatory agencies such as average time to manufacturing, stability, DAR and cytotoxicity of your ADC
- Understanding the limit of active substance impurities such as linker-payload and mAb
- Delving into the control strategies for ADCs to understand which quality attributes to start with in process development
