Cell and Gene Therapy Manufacturing: Scaling Out Without Losing Control

Summary

Autologous therapies scale out rather than up, which multiplies variability. This paper covers process standardisation, chain of identity and facility design for multi-patient manufacturing.

Key takeaways

1. 01Standardising processes across scale-out suites
2. 02Chain of identity and chain of custody controls
3. 03Closed and automated systems that reduce contamination risk
4. 04Release testing under tight vein-to-vein timelines

Written for

• CMC programme managers
• Bioprocess leads
• MSAT teams