Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

Figure 5

Reengineered antibodies display improved developability properties. Panel (a) shows the virtual absence of aggregation for both reengineered variants under native conditions when assessed by GP-HPLC. Panel (b) shows that the percentage of monomer loss after incubation 2 h at 60°C is significantly reduced in both reengineered variants, and virtually eliminated in V#1, indicating improved stability upon reengineering. Panel (c) shows that the productivity increases more than 2-fold in reengineered variants. Panel (d) shows that biological activity is not negatively impacted upon reengineering, with one of the variants V#1 showing increased affinity for the ligand.

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