22. March 2016

The International Conference on Harmonization Q8 (R2) includes a requirement that “Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can impact the quality of the drug product,” that is, the need to assess the robustness of a formulation. In this article, a quality-by-design–based definition of a “robust formulation” for a biopharmaceutical product is proposed and illustrated with a case study....