DATA-DRIVEN PROCESS DEVELOPMENT AND MANUFACTURING OF BIOPHARMACEUTICALS

Disclosed is a method implemented for outputting model(s) for developing or operating a process for a CGT. The method includes receiving, storing, and accessing data items; determining attributes of the data items; selecting one or more machine learning models based on the attributes; accessing one or more mechanistic models; integrating the one or more machine learning models with the one or more mechanistic models to obtain one or more integrated models; selecting one or more predictive models from the one or more machine learning models, the one or more mechanistic models, and the one or more integrated models; applying the one or more predictive models to the data items; adjusting one or more values of one or more parameters of the one or more predictive models to reduce uncertainty in model prediction; and outputting the one or more predictive models with the one or more adjusted values.