Process Optimization in Drug Development

After the formulation is decided and the basic processing determined, it is necessary to optimize each unit process to ensure a robust formulation. Generally, as the project progresses and the clinical studies expand, the process is scaled up, eventually approaching a scale that is close to commercial scale. Scale-up is not necessarily straightforward. The dynamics of granulation and mixing, for example, are such that it can be difficult to predict what will happen on scale up. Nevertheless, with experience success can be achieved.

FinnBrit Consulting has experience in process optimization and can advise clients accordingly.

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