Delving Into the Strategies for Developing Cell-Based Assays to Tackle Development Challenges & Produce a Standardized Approach
Time: 10:00 am
day: Day Two
Details:
• Discussing how ADCs present significant challenges for analytical development including potency assays due to the complexity of the molecules
• Unveiling how regulatory agencies expect a functional cell-based assay from early stage of ADC development because it reflects the mechanism(s) of action, which is not covered by binding assays such as ELISA and SPR
• Discussing the challenges in developing a cell-based assay that is specific to the ADC molecule and can capture the structural/functional changes, as well as the solutions to overcome these challenges and potential standardization of cell-based assays
