Quality-by-design as the pharmaceutical innovation paradigm: mapping the field and proposing a conceptual framework

Abstract

Quality management (QM) and innovation practices are essential for business competitiveness, yet they often conflict when striving for radical advancements within complex innovation ecosystems. Amid this debate, the concept of Quality-by-Design (QbD) remains underexplored in management literature, despite its extensive development in technical fields. Taking the case of QbD in the pharmaceutical sector, this study aims at researching into its relationship with innovation, considering the interactions within the innovation ecosystem. We perform a bibliometric study, a selective content analysis combined with an assessment of the regulatory framework and relevant examples from the industry. Using the duality of the science-push and market-pull approach as the lens of our analysis and its integration with regulatory push, we propose a conceptual framework and illustrate its application using a case study on the development of COVID-19 vaccines. We propose that regulatory agencies and multinationals play a key role in fostering the adoption of QbD. Besides, we suggest that firms benefit from QbD implementation in terms of continuous improvement and, through the latter, radical innovation. This study contributes to the literature by identifying QbD as an ecosystem-based innovation strategy that enables pursuing more radical advances. Our study also inspires a future research agenda.