Dante Romanini
Director, Technical Operations Gilead Sciences
Seminars
Thursday 6th November 2025
Workshop highlights include:
- Sharing feedback from a recent meeting with the FDA on ADC control strategies including regulatory starting materials, impurity control, release testing, and comparability
- Assessing drug-linker attributes in the context of the ADC drug product and its utility in establishing specifications, impurity control strategies, and comparability approaches
- Discussing industry experiences with post-approval changes to drug-linker processes and a framework for managing such changes
Monday 3rd November 2025
Highlighting Lessons Learned From Late-Stage & Commercial ADC Process Transfer Between Manufacturing Facilities
2:30 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
