Benefits of DoE vs. mechanistic modeling along the process development life cycle

When improving biopharmaceutical process development, mathematical models play a crucial role, especially to generate enhanced process understanding and to meet Quality-by-Design (QbD) guidelines. Mathematical models can be built using statistical or mechanistic paradigms.

In this talk, we explore some of the main differences between mechanistic modeling and statistical approaches like Design of Experiments (DoE) along the process development life cycle. And we will learn, that quite often, it is not one or the other approach, but mechanistic modeling and DoE working hand in hand in a hybrid set-up to improve your process development.