Design of Experiments Approach to Enabling Studies for Process Validation

Drug substance

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.

Read our whitepaper, “Design of Experiments Approach to Enabling Studies for Process Validation” to learn more about how Cambrex applied process improvement methodology to the process validation step in order to reduce costs for a client.