A Quality by Design (QbD) approach is being employed to characterize a CHO-based cell culture process producing a monoclonal antibody that is in late stage clinical development. The QbD process starts with an analysis of process parameter risk with respect to critical quality attributes (CQAs) and key performance indicators (KPIs). Initial DOE study designs and the process parameter ranges tested are based on the outcomes of this risk ranking. These initial DOE studies screen factors for significant influences (parameter estimates) on CQAs and KPIs. In addition to describing this QbD approach, the results of initial DOE studies from the seed train, inoculum train and production cell culture steps will be presented.

Characterization of a CHO-based monoclonal antibody production process using a quality by design approach

249th National Meeting (2015)

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