Traditional risk assessments for affinity chromatography process validation study designs rely heavily on product-specific data to identify potential critical process parameters, which result in large validation study designs evaluating multiple parameters that have consistently been observed to not impact product quality. This case study focuses on utilization of patterns revealed by the extraction and consolidation of prior affinity chromatography knowledge to inform and support a streamlined risk assessment for identification of potential critical process parameters. The resulting study design for this monoclonal antibody focused on process parameters that have historically demonstrated an impact on product quality, which saved resources and time while obtaining robust process understanding of the affinity chromatography unit operation.

Leveraging prior knowledge to streamline risk assessment tools and process validation study design

255th National Meeting (2018)

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