Developability and pre-process risk assessment in biopharmaceutical development: a critical aspect in QbD implementation

It is generally assumed that the main cause of discontinuation of new therapeutics in clinical development is related to insufficient or inadequate biological efficacy. However other aspects related to safety of the drug, or commercial motives are equally important reasons behind current failure rates, approaching 90% of all therapeutic products in development. This is where a more comprehensive take on quality (Big Q) is essential to guarantee that more products manage to cross successfully the finishing line, producing both more badly needed treatments for unmet medical need and at affordable costs too. We believe that the integration of manufacturing and discovery activities in a ‘holistic’ interpretation of ‘Quality by Design’ (QbD), could help increasing the efficiency in the development of new drugs. Under this acceptation of the term QbD, implementing developability methodologies, and computational methods in particular, can help reducing risks during early stages of development in a cost-effective way. Such implementation requires a close interaction between discovery and development functions with an integrated objective, the design and development of optimal drug candidates. Some potential workflows and areas of impact will be introduced to exemplify the use of developability strategies with the aim of mitigating risks, reduce drug attrition and ultimately increase the robustness of the biopharmaceutical supply chain. Furthermore, we believe that this type of approach could also help accelerating the access of new therapeutic treatments to patients in the clinic, potentially streamlining preclinical development by averting failure before it occurs.