Overcoming Challenges in Qualifying Flow Cytometry Assays for Cell-Based Therapies
Time: 2:05 pm
day: Track B - Immunophenotype Assay (Day Two - Afternoon)
Details:
- Ensuring reproducibility is challenging due to the complexity and heterogeneity of cell populations and the variability in sample preparation and instrument performance.
- Developing robust, standardized protocols and maintaining regular calibration and maintenance schedules for flow cytometers are essential to achieving consistent and reliable results.
- Utilizing advanced data analysis tools, consistent gating strategies, and early engagement with regulatory bodies can help manage the complexity of data and ensure compliance with regulatory standards.
