Roundtable Discussion: Mitigating Batch-to-Batch Variability Through Reproducible Process Controls & In- Process Monitoring
- What are the main process conditions and impurities driving batch-to-batch variability during LNP scale-up?
- At which critical points in the manufacturing process should in-process analytics be implemented for real-time quality monitoring?
- How can process controls be designed to ensure reproducibility and consistency during scale up and across batches?