Process validation was performed for a recombinant protein using the Quality by Design (QbD) approach. Defining a design space allows for better process understanding and regulatory relief, but typically requires increased resources and time investment. Several strategies were implemented to improve efficiency for study execution and identification of critical quality attributes (CQAs) tested during process validation.  Activities were re-sequenced to eliminate interdependencies, balance the workload, and avoid bottlenecks in timelines driving the commercial license application filing. Despite the lack of platform knowledge for this molecule, applicable historical and development data were leveraged to eliminate CQAs for testing or entire studies based on risk assessments.  Spiking and process linkage studies for selected CQAs were accelerated and performed upfront to inform risk assessments to streamline both CQAs tested and process parameters studied during process validation. This enabled early availability of process validation data, which informed timely control strategy decisions. Overall, these strategies worked synergistically to reduce the resources and time required to streamline the QbD package, including the elimination of several studies from critical path in the regulatory filing timeline.<br/>

Defining design space: Strategies to improve efficiency during process validation

253rd National Meeting (2017)

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