Safety Strategy for iPSC-derived Allogeneic Cell Therapy Drug Product Release 

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