Advancing scalable, high-quality, and data-driven manufacturing for cell and gene therapies through collaboration and digital innovation.

 

 

Introduction

The Manufacturing Workstream focuses on improving how cell and gene therapies are produced and scaled to meet global patient needs. It brings together manufacturing leaders, developers, and digital innovators to overcome shared challenges and accelerate progress toward safe, reliable, and accessible production.

 

The Challenge

Manufacturing remains one of the most significant bottlenecks in the delivery of advanced therapies. A lack of standardised data sharing and fragmented systems slow progress, limit process optimisation, and make large-scale production difficult to achieve.

 

Our Approach

To address these challenges, the Manufacturing Workstream is developing a digital, standardised process development database to enable secure and efficient data sharing between organisations. This collaborative initiative helps accelerate development timelines, improve optimisation outcomes, and support data-driven decision making.

A proof-of-concept project using non-clinical CAR-T process development data is already underway, with participating organisations contributing to a shared framework that will inform future scalability across the field.

 

Progress So Far

• Process parameter checklist agreed between participating organisations
• Data-sharing agreements signed following legal review
• AutoloMATE platform and data collection form prepared
• Data sharing now in progress, with analysis to follow

 

Looking Ahead

The long-term vision is to create a shared CAR-T process development database built from multi-institutional data. Insights from this initiative will help drive greater transparency, efficiency, and scalability in advanced therapy manufacturing, supporting better access for patients worldwide.