The approach to Quality by Design process validation at Genentech incorporates a risk- and science-based approach, in which an understanding of potential critical quality attributes (pCQAs) enables the identification of potential critical process parameters (pCPPs) through a risk-ranking and filtering (RRF) procedure.  The RRF procedure incorporates knowledge from a variety of sources to identify a subset of high-risk process parameters as pCPPs, which undergo comprehensive evaluation in subsequent process validation (PV) studies.  In this way, the RRF procedure allows the design of focused and efficient PV studies.  Here, a case study is presented in which the RRF exercise for the chromatographic purification of a monoclonal antibody has been facilitated through the incorporation of low resolution screening DOEs, platform knowledge, process linkage information, and a product-specific mechanistic chromatography model, in order to augment data from product-specific experimental data from process development.  This approach has resulted in high-resolution, multivariate design of experiment (DOE) PV studies that are significantly reduced in scale from similar previous PV studies.<br/>

Strategies to streamline risk ranking and filtering in quality by design process validation

253rd National Meeting (2017)

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