JC Chi
Director BeOne Medicines
Seminars
Thursday 10th September 2026
Scaling Up iPSC Production to Commercial Volumes Without Re‑Validation Delays or Loss of Potency
1:30 pm
- Unlocking true scale‑up beyond single‑litre bioreactors by controlling aggregate size, metabolism and division behavior
- Reducing the re‑validation load at each scale jump by locking critical process parameters early and establishing comparability frameworks that regulators accept
- Addressing the cost and operational barriers of moving from RUO‑scale runs to commercial‑volume manufacturing while maintaining CQAs and batch‑to‑batch robustness
