Digital Medicines Manufacturing (DM2) Research Centre

Lead: Professor Blair Johnston, University of Strathclyde

Aims: To address one of the sector's core digitalisation challenges - a lack of large data sets and ways to access such data.

Objectives:

• Build data systems to clean, archive and serve data across Platforms
• Capture and create data models for Platforms 2 - 4
• Establish DM2 Data Services with partners to maximise data value and growth
• Develop novel, data driven AI tools for data handling, analysis and prediction
• Develop standards to ensure accuracy and reusability, establishing “gold-standard” curated data sets

Lead: Dr Daniel Markl and Professor Gareth Pierce, University of Strathclyde

Aims: To accelerate the development of medicine products and manufacturing processes by creating agile, small-scale production facilities and using robotic technologies.

Objectives:

• Create an automated mini-batch direct compression and capsule filling IDT manufacturing demonstrator
• Demonstrate an autonomous IDT manufacturing demonstrator to predictively formulate new OSDs for phase 1 clinical supply
• Develop fundamental understanding about the material – process – performance relationship for tablets and capsules

Lead: Dr Brahim Benyahia, Loughborough University

Aims: To drive digitalisation of Quality Control (QC) aspects of medicines development  - critical for ensuring a medicine's regulatory compliance and patient safety.

Objectives:

• Learn to utilise prior knowledge and data against specifications to automate raw material release
• Design optimal reliable operating regions (ROR) to meet CQAs and regulatory standards
• Real time measured and predicted (soft sensors) CQAs to achieve predictive real time release testing (RTRT) displacing extensive off-line analysis and reducing waste by 30%
• Build a self-optimising QC Digital Twin into the process to streamline regulatory compliance multiple tablet and capsule formulations alongside an advanced control and fault detection strategy

Lead: Dr Jag Srai, University of Cambridge

Aims: To generate new understanding on future supply chain needs of medicines to support adoption of adaptive digital supply chains for patient-centric supply.

Objectives:

• Develop three Digital Supply Chain Use-Case Models that capture material, information, and value flows enabling data-driven replenishment based on actual user demand
• Identify relevant IDT interventions that enable actual demand-capture and automated supply & replenishment
• Develop alternative digital supply chain configurations based on autonomous manufacturing driven by patient need

Lead: Dr Andrea Johnston, University of Strathclyde

Aims: To lead engagement, collaboration and skills development by establishing the DM2 network & skills programme.

Objectives:

• Act as a springboard for DM2 to share developments and insights across pharma and broader digital manufacturing sectors ensuring cross-sector diffusion
• Work with existing strategic networks to expand reach for IDT dissemination and uptake
• Identify skills needs for the future workforce and, with partners, develop and deliver training
• Create case studies to inform responsible research, innovation, and trust in IDTs