Dante Romanini
Director, Technical Operations Gilead Sciences
Seminars
Thursday 6th November 2025
Workshop highlights include:
- Breaking down the end-to-end playbook for drug-linker CMC development including: specifications and impurity control strategy, comparability, process development and validation, stability, and post-approval changesÂ
- Delving into framework for purge factor calculations and experimental evaluation of clearance of small molecule impurities in the ADC drug substance manufacturing process
- Exploring ADC IND and BLA filing strategies and recommendations per the ICH M4Q (R2) framework
Monday 3rd November 2025
Highlighting Lessons Learned From Late- Stage & Commercial ADC Process Transfer Between Manufacturing Facilities
2:00 pm
- Laying out experiences in translating parametric control strategy elements into robust on-the-floor operations
- Exploring strategies to ensure consistent conjugation performance and product quality with different equipment and facility design
- Assessing validation approaches to build robust commercial supply capabilities
