Cell and gene therapies have transformative potential for millions of patients worldwide with previously untreatable conditions. However, to ensure that patients receive the therapies they require, the sector must ensure a scale up of manufacturing capabilities.
Highly complex, manual, and inefficient manufacturing processes drive up production costs, resulting in extremely expensive therapies and complicated supply chains, causing reimbursement and uptake challenges. Critically, this complexity leads to a restriction in the global supply needed to serve the hundreds of thousands to millions of patients who will soon become eligible for CGTs.
These challenges stem from key inefficiencies including manual paper-based data capture and reporting methods requiring extensive Quality Assurance (QA) reviews and consuming significant time and resources, whilst increasing human error and batch failure risk, which can be catastrophic for patients. Furthermore, non-standardised data formats, widespread data silos, and fragmented data infrastructures exacerbate these challenges.
This whitepaper provides an overview of the process, outputs and lessons learned from a collaboration between Autolomous and the Cell and Gene Therapy Catapult, on using digital technologies to improve the efficiency and reduce the cost of manufacturing cell and gene therapies. The collaboration took place at the Cell and Gene Therapy Catapult’s MHRA-licensed Braintree Manufacturing Innovation Centre.
Click the image below to access the whitepaper.
