Expanding Perspectives on Potency Assays in Cell Therapy: Beyond Primary Mechanisms
Time: 12:00 pm
day: Track A - Cell Based Assay (Day One - Morning)
Details:
- Explore the evolving definition of potency assays beyond traditional metrics like cell-based killing, delving into engineered attributes crucial for therapeutic efficacy.
- Discuss the need for functional assays to evaluate engineered functions such as evading the host immune system, aligning with evolving FDA guidance and label claim requirements.
- Delve into the role of protein expression as a surrogate marker for potency.
