Review Article

Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

Figure 3

Correlation between antibody productivity and aggregation in three different antibody families: mAb1, mAb2, and mAb3. Variants were derived from three different parental antibody molecules by incorporating single and double sequence modifications. All different antibodies were expressed transiently under identical conditions to minimise any clonal variability in expression. Relative aggregation was assessed using Lonza’s Oligomer Detection Assay, or ODA [11].