
Highlights
- What is a bioprocess scale down model;
- Regulatory guidance about scale down models;
- Pitfalls in developing scale-down models;
- Best practices to qualify scale-down models.
You develop, optimize and characterize bioprocesses in laboratory scale. Yet, you expect that the insights from laboratory scale do not change during scale-up. Hence, your laboratory results are representative and predictive for the final manufacturing scale. To ensure that, you need a robust and predictive bioprocess scale-down model. Therefore, developing the bioprocess scale-down model is the core of your development and validation activities.