Comprehending & Facing Regulatory Approval Challenges to Overcome Hurdles in ADC Scale-Up Processes
Time: 9:30 am
day: Day One
Details:
- Exploring real life approved ADC case studies to understand the lessons learnt from adjusting processes to regulatory requirements
- Setting wide enough specifications for scale up, which still fall within regulatory acceptance criteria of impurity limits
- Understanding the regulatory frameworks for speeding up time to manufacturing
