Quality by digital design to accelerate sustainable medicines development.

We present a shared industry-academic perspective on the principles and opportunities for Quality by Digital Design (QbDD) as a framework to accelerate medicines development and enable regulatory innovation for new medicines approvals. This approach exploits emerging capabilities in industrial digital technologies to achieve robust control strategies assuring product quality and patient safety whilst reducing development time/costs, improving research and development efficiency, embedding sustainability into new products and processes, and promoting supply chain resilience. Key QbDD drivers include the opportunity for new scientific understanding and advanced simulation and model-driven, automated experimental approaches. QbDD accelerates the identification and exploration of more robust design spaces. Opportunities to optimise multiple objectives emerge in route selection, manufacturability and sustainability whilst assuring product quality. Challenges to QbDD adoption include siloed data and information sources across development stages, gaps in predictive capabilities, and the current extensive reliance on empirical knowledge and judgement. These challenges can be addressed via QbDD workflows; model-driven experimental design to collect and structure findable, accessible, interoperable and reusable (FAIR) data; and chemistry, manufacturing and control ontologies for shareable and reusable knowledge. Additionally, improved product, process, and performance predictive tools must be developed and exploited to provide a holistic end-to-end development approach.