Autolomous Ltd, a developer of critical manufacturing management systems for advanced therapies, and the Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry, have demonstrated how to implement digital technologies into advanced therapy manufacturing.
As more cell and gene therapies come to market, the industry faces growing pressure to develop manufacturing processes that are more efficient, scalable, and cost-effective. Digital platforms have the potential to play a critical role in this transformation by replacing paper-based and manual workflows, streamlining operations, and enhancing overall productivity.
In this project, Autolomous and the CGT Catapult transitioned the manufacturing of adeno-associated virus (AAV) vectors from a paper-based, manual recording and data management system, to a Good Manufacturing Practice (GMP)-compliant digital process that uses autoloMATE® software. They integrated various manufacturing and quality management systems, including Process Analytical Technologies, into the automated data platform, reducing manual intervention and allowing for data to be shared in real-time across different stages of production.
The project clearly demonstrates the benefits of implementing digital technologies. For example, there was a 65% decrease in the time taken to review the batch documentation, which equated to saving 100 days’ work for a full-time quality assurance professional; a 40% reduction in manual data entry due to automation, which also resulted in an data error entry rate of close to zero; and the amount of paper used per manufacturing batch reduced from 894 sheets to zero.
Digital technologies have the potential to deliver more efficient, safe, and scalable manufacturing outcomes. Through working with digital experts at Autolomous, we are helping industry to understand both the path, and quantitative benefits, of implementing these technologies. By embracing digitalisation, we can remove constraints and support industry to meet the growing demand and ensure patients have access to the treatments they need.
Dr Stephen Ward, Chief Technology Officer at the CGT Catapult
This partnership with the CGT Catapult has successfully validated the critical role digital technologies play in advanced therapy manufacturing. By transitioning from paper-based processes to a digital platform such as autoloMATE, we have demonstrated tangible improvements in efficiency and data integrity. But this isn't just about streamlining operations; it's about building a scalable foundation that will ultimately accelerate the delivery of life-changing therapies to the patients who need them most.
Alexander Seyf, Autolomous CEO and Co-founder
The two-year project was funded through a £1.2 million grant from UK Research and Innovation (UKRI).