From Early to Late Phase: the Evolution of an Autologous Cell and Gene Therapy Potency Assay
Time: 12:00 pm
day: Track A - Day 2 AM
Details:
- Technical aspects of autologous ex vivo CGT potency assays
- A case study of a CGT potency assay evolving from early to late-stage development
- Backdrop of regulatory and phase-appropriate considerations driving the evolution of the assay toward late stage development
