Quality by Design approaches to assessing the robustness of tangential flow filtration for MAb.

Quality by Design (QbD) is a modern approach for quality assurance in pharmaceutical production. This article illustrates a case study of TFF robustness performed for a process characterization of a monoclonal antibody under QbD principles by exploring functional relationships that link the process parameters to quality/process attributes with prior process knowledge, risk assessment, and multivariate experiments. In every case of quality or process attributes, all measured values were in alignment with the allowable specification range, and the developed models were non-significant and had no lack of fit, thus confirming the robustness of the TFF process within the tested ranges of process parameters.