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Step-wise strategy to address process characterization and late phase development -- toward the definition of a standardized approach.

Different approaches have been reported for process characterization but contain common elements including risk assessment, scale-down model qualification, and statistical design of experiments. However, there is not a consensus on criteria for the selection of a unique or multiple experimental designs for the evaluation of Critical Process Parameters (CPP) at every stage. The purpose of this work is to propose a stepwise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody. This approach will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.