Design of Experiment (DoE) is the centerpiece of analytical Quality by Design. A DoE assay development pipeline approach delivers optimized, robust, and rugged analytical methods ready for method qualification.
Four experts share how scale-up, regulatory expectations, demand forecasting, and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.
Determining size homogeneity of a mAb in solution is important for comparability and characterization. For this study, an IgG1 antibody was cleaved into antigen-binding fragments using pepsin and papain digestion respectively, followed by Protein A purification.