Digital Twins in Biomanufacturing.

In recent years process modelling has become an established method which generates digital twins of manufacturing plant operation with the aid of numerically solved process models. This article discusses the benefits of establishing process modelling, in-house or by cooperation, in order to support the workflow from process development, piloting and engineering up to manufacturing. The examples are chosen from the variety of botanicals and biologics manufacturing thus proving the broad applicability from variable feedstock of natural plant extracts of secondary metabolites to fermentation of complex molecules like mAbs, fragments, proteins and peptides.Consistent models and methods to simulate whole processes are available. To determine the physical properties used as model parameters, efficient laboratory-scale experiments are implemented. These parameters are case specific since there is no database for complex molecules of biologics and botanicals in pharmaceutical industry, yet.Moreover, Quality-by-Design approaches, demanded by regulatory authorities, are integrated within those predictive modelling procedures. The models could be proven to be valid and predictive under regulatory aspects. Process modelling does earn its money from the first day of application. Process modelling is a key-enabling tool towards cost-efficient digitalization in chemical-pharmaceutical industries.