Developability Assessment Workflows to De-Risk Biopharmaceutical Development

Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

“…For example, the evaluation of the relative importance of different risks during lead selection and their potential impact in product quality and clinical success remains a mayor challenge that needs to be tackled. We have started to address some of these issues elsewhere [ 89 ], but anticipate that alongside the introduction of predictive algorithms and surrogate analytics discussed here, the implementation of better data integration, and the development of objective decision-making tools will facilitate a more effective application of the methodologies reviewed in this article. This will, very likely, not only involve the development of new technical solutions, like computational models and tools, but also some degree of coordination and alignment across different industry stakeholders, from innovators to contractors to regulatory bodies to healthcare providers.…”

“…As we have discussed, there are areas where new developments are needed to produce better predictive approaches and ultimately a balance needs to be achieved between both approaches to maximise outcomes. We have discussed elsewhere how such a balance could be articulated at different stages of development and, more importantly how different decision-making tools could be defined to achieve effective solutions that would improve success during preclinical and clinical development [ 89 ].…”