In this two-year project, the collaborators want to develop a digitized and automated AAV gene therapy manufacturing platform. By combining their expertise in manufacturing and process analytics with innovative process analytical technologies (PAT), they will develop automated monitoring and control, which will be applied to Rentschler Biopharma’s existing AAV manufacturing process.

The partners plan to carry out high throughput and automated sampling and analysis of AAV material throughout the production process. This data will be used to create digital twins to further refine the process and make it more efficient. The use of digital twins to model changes in the process could reduce the number of expensive and time-consuming physical tests.

As part of the collaboration, automated analytical technologies will be investigated for their impact on improving productivity and AAV yield. This will include using Refeyn’s technology to assess the proportion of full AAV capsids produced – a key factor tha indicates process efficiency but may also impact clinical efficacy. Refeyn will also use the project to test its new cGMP compliant version of a mass photometer.

Christian Schetter, chief scientific officer of Rentschler Biopharma, said: “With this collaborative project working with world-class partners, we seek to unleash the potential of faster viral vector development with multi-parameter driven optimization. This promises to translate to higher outputs, robustness, and better process control; ultimately lowering the risk associated with the transition from early to late-stage manufacturing for the benefit of our clients and their patients.”