By Christa Short, Midge Bonzon, Jonathan Mitschelen, Upstream Process Development, R&D Services
This poster is a version of slides presented at PEGS Summit in Boston, MA, in the session of "Scaling Up and Down Strategies for Protein Production."
The case study presented involved the production of a Phase 1 clinical trial material at a100 L scale with limited process development prior to cGMP production and productivity of <1 g/L, below industry standard. A scale-up to 1,000 L was planned for a Phase 2 clinical supply, with an initial 1,000 L batch being successful with similar yield to 100 L batches. The second 1,000 L batch failed to reach normal cell density, and yield was much lower than normal. Risk mitigation for a third batch included rigorous data review and the implementation of a process control strategy.
- Impact on Manufacturing
- Company Strategies
- Regulatory Considerations
- mAb Process Flowchart
- mAb Production Process
- Process Performance History
- Glutamate Issues & Process Range
- Process Change Options
- Final Change and Justification