Process validation studies are performed to support and demonstrate process robustness and understanding to inform proper controls to ensure high-quality supply. Although most processes are optimized to meet program-specific criteria, some process design elements have been consistently implemented across multiple programs and demonstrated similar process effects. This extensive history and experience of antibody therapeutics within and across the industry may provide relevant information to enable science- and risk-based decisions. Through effective knowledge management per ICH10 and ICH11, captured historical knowledge can facilitate data review as well as be further structured to compare overall trends and inform associated risks for future process validation studies. A case study utilizing prior knowledge for affinity chromatography will be provided.

Application and strategy of leveraging prior knowledge to facilitate process validation activities

253rd National Meeting (2017)

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