In this session, Phil Ramsey (Senior Data Scientist and Statistical Consultant at Predictum Inc. and Owner of the North Haven Group) uses bio-process development case studies to demonstrate that the augmented FQM models substantially outperform the traditional FQM in characterizing the full design space. After explaining why we need Design of Experiments (DoE) and predictive models for quality by design (QbD), Dr. Ramsey uses JMP Pro to demonstrate the application of augmented FQMs, FWB, and the Simulators in the JMP Profilers to fully characterize design spaces as required by QbD.