Streamlining Potency Assay Development in Cell & Gene Therapies: from Pre-IND to BLAx
Time: 12:30 pm
day: Conference Day One
Details:
- Phase-appropriate matrix approach towards potency assay development for CGTs
- Identifying technical challenges & accounting for criticality ni potency assay development for CGTs
- Regulatory & CMC considerations in CGT potency assay development; from pre-IND to BLA
