Design Of Experiments Approach To Enabling Studies For Process Validation

By Matthew Schiesher, Ph.D., Research Fellow, Cambrex

Process validation is a key step in preparing for commercial active pharmaceutical ingredient (API) production, requiring a significant depth of knowledge and data related to the manufacturing process. Appropriate design, execution, and interpretation of lab studies enable the definition of a process knowledge map and justify the operational region to ensure the API is manufactured in a safe and consistent manner, meeting all quality and regulatory requirements. And while compliance is always a top priority for sponsors, so too is developing an efficient process that can help reduce the late-stage development costs often incurred during API production.

In a recent project, Cambrex applied process improvement methodology to the process validation step in order to reduce costs for their client. The multi-faceted approach outlined below defined manufacturing parameters without the expense of surplus experimentation, as well as identified impactful process improvements that ultimately provided not only an optimized, robust process but also an economic advantage. Download the full article for about this methodology as well as a detailed look at its implementation within Cambrex.