Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

Figure 2

Developability flowchart. The flowchart illustrates how a development plan could be articulated to integrate effectively developability risk assessment tools. Setting an intended performance profile (QTPP) based on indication, pharmacology, mode of action, market, and delivery, amongst other considerations, allows the developer to determine the CQAs against which the lead candidate and process should be evaluated. A developability risk assessment would help identify specific risks impacting those CQAs and design and implement a risk-mitigation plan. This might involve modification in the selection or design of a lead candidate, potential reengineering (product), designing specific elements of the manufacturing process aimed to minimise or control risk, or perhaps some specific formulation requirements. All these steps will define the final product specifications in terms of measurable and controllable characteristics.