Ensuring quality of cell therapy products is required through all stages of development and manufacturing. Quality is confirmed through process design, raw materials testing, in-process testing and release testing. Multiple methods throughout the biomanufacturing process assess the identity, purity, potency and safety of the final product. Here we will explore a strategy case-study for assuring the safety of a final iPSC-derived allogenic drug product while addressing specific regulatory expectations. Topics will include:
- Meeting regulatory expectations for demonstration of safety
- Selecting appropriate methods for genetic characterization
- Identifying informative variant class assessments at each manufacturing stage