Developments in the world of biologic medicine are transforming the lives of increasing numbers of individuals across the globe. However, as the complexity of molecules increases, designing scalable manufacturing processes is a challenge. An optimised process results in highly purified material from the smallest number of batches to meet clinical timelines as well as get ready for a commercial launch, at the same time as managing quality, supply and cost. Furthermore, an optimised process should streamline operations, minimise the risk of failure, and improve consistency and robustness. In addition, you need to use engineering control to stop contamination events or adventitious agent introductions. Accounting for all those factors should result in manufacturing success over the long term.

There are essentially three key questions you need to refer back to during the optimisation process:

1. Can the Process Be Simplified?

In many cases, a process that is easy to carry