A tool for modeling strategic decisions in cell culture manufacturing

The development of a prototype tool for modeling manufacturing in a biophar maceutical plant is discussed. A hierarchical approach to modeling a manufa cturing process has been adopted to confer maximum user flexibility. The us e of this framework for assessing the impact of manufacturing decisions on strategic technical and business indicators is demonstrated via a case stud y. In the case study, which takes the example of a mammalian cell culture p rocess delivering a therapeutic for clinical trials, the dynamic modeling t ool indicates how manufacturing options affect the demands on resources and the associated manufacturing costs. The example illustrates how the decisi on-support software can be used by biopharmaceutical companies to investiga te the effects of working toward different strategic goals on the cost-effe ctiveness of the process, prior to committing to a particular option.