Quality by digital design to accelerate sustainable medicines development

Area of Science:

• Pharmaceutical Sciences
• Digital Health
• Chemical Engineering

Background:

• The pharmaceutical industry faces challenges in accelerating drug development and regulatory innovation.
• Emerging digital technologies offer opportunities to enhance product quality, patient safety, and R&D efficiency.
• Current development processes often suffer from siloed data and reliance on empirical knowledge.

Purpose of the Study:

• To present an industry-academic perspective on Quality by Digital Design (QbDD) as a framework.
• To explore the principles and opportunities QbDD offers for medicines development and regulatory innovation.
• To identify challenges and propose solutions for QbDD adoption.

Main Methods:

• Exploiting industrial digital technologies for robust control strategies.
• Utilizing advanced simulation and model-driven, automated experimental approaches.
• Implementing QbDD workflows, FAIR data principles, and ontologies for knowledge management.

Main Results:

• QbDD accelerates the identification and exploration of robust design spaces.
• Opportunities exist to optimize route selection, manufacturability, and sustainability while ensuring quality.
• Addressing data silos and predictive capability gaps is crucial for holistic development.

Conclusions:

• Quality by Digital Design (QbDD) provides a framework to accelerate medicines development and regulatory innovation.
• QbDD enhances product quality, patient safety, R&D efficiency, and supply chain resilience.
• Overcoming challenges through FAIR data, ontologies, and predictive tools is key to successful QbDD implementation.