About Model Validation in Bioprocessing

In bioprocess engineering the Qualtiy by Design (QbD) initiative encourages use of models to define design spaces. However, clear guidelines on how for QbD are validated still missing. this review we provide a comprehensive overview validation methods, mathematical approaches, and metrics currently applied in modeling. The methods cover analytics data used modeling, model training selection, measures predictiveness, uncertainties. We point out general issues calibration different types put into context existing health authority recommendations. This provides starting developing guide approaches. There is no one-fits-all approach, but should help identify best fitting method, or combination specific task type that being developed.