Quality by Digital Design (QbDD) to Accelerate Sustainable Medicines Development
The CMAC Future Manufacturing Research Hub has co-developed the Quality by Digital Design (QbDD) approach to support digital transformation of medicines development and manufacturing
Key Elements of QbDD
Standardised digital workflows to drive activities
Integrated digital tools and self-driving labs
Unified, structured and standardised data management
Verification and validation of digital tools via experimentation
Risk assessment and control strategies using digital tools
Upskilling for a tech-savvy workforce
Collaboration between academic, industrial and regulatory stakeholders
Challenge
Pharmaceutical manufacturing consists of lengthy, complex processes, with resource-intensive development. There is a need for more sustainable practices while maintaining regulatory compliance and ensuring product quality, whilst accelerating the development of new manufacturing approaches and products.
Approach
QbDD is a strategic approach to pharmaceutical manufacturing that builds upon existing Quality by Design principles by applying modelling and digital tools. QbDD enhances sustainability, efficiency, and innovation while assuring quality of the final product.
QbDD integrates data from across manufacturing. Images provided by researchers from the CMAC National Facility and the EPSRC CMAC Future Manufacturing Research Hub.
Skills and Training
Workflows rapidly on-board users to QbDD
Digital workflows democratise knowledge of medicines manufacturing and accelerate adoption of QbDD
Regulatory Innovation
Digital transformation enhances transparency, security, robustness, accountability, contestability and safety
A comprehensive digital audit trail enables straightforward assessment of the processes and products developed
Benefits and Expected Impact
Improved Efficiency and Sustainability:
Digital first approaches reduce material use, energy consumption and development time
Virtual assessment reduces risk of staff and environmental exposure to more potent materials and solvents
Ensured Product Quality and Consistency:
QbDD combines patient-focussed quality targets with key manufacturing objectives and constraints
DataFactories (self-driving labs equipped for intelligent data generation) train and exploit digital tools, enabling real-time improvement
Standardised approaches make data Findable, Accessible, Interoperable and Reusable (FAIR)
Conclusion
QbDD provides a science-driven rationale informed by digital design tools to develop processes that meet quality, manufacturability, process sustainability, and business targets. While full realisation of QbDD will require time and resources to develop and integrate the digital technologies, investment in QbDD will bring substantial benefits. CMAC’s programmes continue to develop innovative approaches together with our industry partners.
Published Work
For more information on the elements, implementation, and impact of QbDD please read our paper Quality by Digital Design (QbDD) to Accelerate Sustainable Medicines Development.
