Analytical Development & Improvement of Bioassay for ADC During the Method Lifecycle
Time: 11:30 am
day: Day Two
Details:
• Discussing how for an ADC, a bioassay is recommended from early stage of development in order to reflect the mechanism of action which is directly related to the antibody but also to the conjugated drug. This particularity has the advantage to allow acquiring a better understanding of the method performance early in the product development
• Illustrating with examples how different steps during the method lifecycle (robustness study, method transfer, monitoring of the method performance, etc) allow improving the assay for late stage and registration
• Outlining how those changes can be managed, depending on the stage of the project and the extent of the change
