Melvin Flores

• Provide comprehensive, hands-on training for QC analysts in aseptic technique and cell culture to ensure consistent andsterile handling of living cell lines, minimize contamination events, and ensure the reliability of the potency data generated at the QC site
• Co-develop detailed and unambiguous method instructions with the receiving lab to eliminate variability introduced by differences in interpretation or execution, ensuring the assay performs identically at both the development and QC sites
• Establishing a joint trending program for key assay performance indicators during transfer to identify and troubleshoot any drift or performance issues, maintaining the long-term robustness and GMP compliance of the potency method

Moving beyond solving individual transfer issues to envision a future state of fully integrated development, powered by AI and automation. This panel will debate the cultural, technical, and regulatory roadblocks to achieving the transformative impact it would have on speed, cost, and quality.

Join a strategic discussion on building the agile ADC development organization of the future by:

• Envisioning how AI platforms analyze development data to automatically recommend optimal process parameters, analytical methods, and specifications, changing the role of scientists
• Exploring digital replica of the ADC process to virtually simulate the impact of changes, predict outcomes, and eliminate failed tech transfers
• Debating the organizational and cultural changes required to break down walls between process, analytical, and regulatory functions, enabling a truly agile and data-driven development lifecycle