Scaling Sterile Fill-Finish: Capacity Planning for the Next Wave of Biologics

Summary

Demand for sterile injectables is outpacing available fill-finish capacity. This paper sets out a planning model for sponsors and CDMOs that links pipeline forecasts to line availability, isolator technology choices and technology-transfer timelines.

Key takeaways

1. 01A forecasting model that connects clinical pipeline stage to fill-finish slot demand
2. 02Isolator versus RABS: total cost and changeover trade-offs across batch sizes
3. 03Where technology transfer most often slips, and the checkpoints that prevent it
4. 04Questions to ask a CDMO before reserving capacity

Written for

• Heads of manufacturing
• External supply leads
• CMC programme managers