The role of process simulation and scheduling tools in the development and manufacturing of biopharmaceuticals

Pharmaceutical manufacturers generally employ either organic synthesis or biotechnology. Each of these technologies has unique challenges, but batch process simulation and scheduling tools can facilitate process development in both. Batch process simulation is distinct from both traditional chemical process simulation and dynamic simulation and is uniquely suited to pharmaceutical processes. Furthermore, there is a close relationship between the data required for batch simulation and the data required for batch process scheduling. An example biopharmaceutical process illustrates how batch simulation can help improve a process. A scheduling example illustrates the relationship between batch simulation and scheduling.