Highly personalised advanced therapy medicinal products (ATMP) such as cell & gene therapies (CGT) represent a breakthrough in medicine, with the promise to become one-off cures for a wide range of conditions. However, making CGT products widely available to patients proved challenging so far. Existing CGT manufacturing processes involve multiple manual steps that need to be performed in high grade clean rooms by skilled professionals who have limited tools to monitor progress over time. This leads to two major problems: unpredictable outcome and high cost – a single dose can cost anywhere from €250k-€2m due, in part, to the labor-intensive nature of the process.
PAT4CGT consortium aimed to overcome these obstacles by developing a solution that supports fully automated CGT manufacturing processes. To achieve the objectives of the project, partners have developed a self-contained analytical instrument to enable non-invasive real-time in-line sensing of critical process parameters (CPPs). Coupled with process automation, this solution will monitor the overall status of the cell culture, obliterating the need for manual sampling steps. The consortium has pooled the expertise of partners to define these CPPs and better understand their role, so that optimal conditions can be found, and process parameters adjusted. The collected data was used to build digital twin models and prediction algorithms that allow process control and increase product quality. The resulting tool will help CGT developers identify key relationships between CPPs, as potential predictors of cell quality and therapeutic outcome. Ultimately, the developed device will enable the biopharma industry to scale CGT production and help patients to access these innovative therapies.
