A case study of a Quality-by-Design (QbD) approach to characterizing a Monoclonal Antibody (MAb) purification process is presented.  First, a risk ranking and filtering (RRF) tool is used to identify parameters for process characterization.  Second, multivariate characterization studies are designed and executed based on the output of the RRF tool.  Third, the results of the characterization studies are analyzed to evaluate the impact of each process parameter on pre-determined Critical Quality Attributes (CQAs).  A dimensionless indicator of criticality, called Impact Ratio, is used as a quantitative and consistent measure of parameter impact across multiple parameters and unit operations. Fourth, linkage studies are performed at worst-case for each CQA, to allow a highly conservative and efficient method of exploring the edges of the Design Space across the entire purification process.  In conclusion, the implications of process characterization results to the MAb manufacturing Control Strategy will be discussed.

Implementation of a fully integrated QbD approach for a MAb purification process

243rd National Meeting (2012)

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