Drivers for process characterization and late phase development include improving process understanding, enhancing process robustness, and assurance that the process delivers consistent product quality within all Proven Acceptable Ranges (PARs).

Regulator’s expectations for biologic submissions include the application of statistical methods to improve the confidence of the PARs and knowledge of the design space for a process. 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.