Strategies for Designing Quality Control-Friendly Flow Cytometry Panels in Cell Therapy Development
Time: 2:00 pm
day: Track B - Immunophenotype Assay (Day Two - Afternoon)
Details:
- Explore strategies for designing flow cytometry panels that balance the need to cover product characteristics and impurities while adhering to quality control-friendly limitations, such as color restrictions.
- Examine the implications of the recent FDA potency assay draft guidelines on cell therapy development programs, including the importance of studying mechanism of action from early phases and ensuring compliance with evolving regulatory standards.
