Over 65% of gene therapies in development currently are based on AAV. However, the production of AAV is difficult and time consuming, partly because current analytical methods mainly rely on manual sampling.
In this two-year project, the collaborators will develop a digitised and automated AAV gene therapy manufacturing platform.
By combining their knowledge in manufacturing and process analytics with ‘cutting edge’ PAT, they will develop automated monitoring and control, which will be applied to Rentschler Biopharma’s existing AAV manufacturing process.
The teams will carry out high throughput and automated sampling and analysis of AAV material throughout the production process.
This data will be leveraged for the creation of digital twins: digital models of the manufacturing process that can be used to further refine and improve the efficiency of the process.
Using these digital models, the team can carry out the initial tests of any changes to the process in a digital environment, which should reduce the number of expensive and time-consuming physical tests which need to be carried out in the laboratory.
They will assess any improvements in productivity and AAV yield using automated analytical technologies.
This will include using Refeyn’s technology to assess the proportion of full AAV capsids produced. This is a key measurement for the industry, as quantity of full AAV capsids indicates process efficiency but may also impact clinical efficacy. Refeyn will also use the project to test its new Good Manufacturing Practice compliant (cGMP) version of its mass photometer.
Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, said: “The combination of the global manufacturing experience of Rentschler Biopharma, the leading edge science of Refeyn, and CGT Catapult’s digital and analytical capabilities is already shaping up to be a powerful collaboration. We expect the collaboration to make a significant contribution to enhanced manufacturing capability for the industry.”
Dr. Christian Schetter, chief scientific officer of Rentschler Biopharma, added: “With this collaborative project working with world-class partners, we seek to unleash the potential of faster viral vector development with multi-parameter driven optimisation. 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.”
Dr. Matthias Langhorst, chief product officer at Refeyn, commented: “We are excited to be part of this project which is bringing important innovation to viral vector development and manufacturing. The outputs will help us understand the future needs of viral vector manufacturing environments, informing product development to better satisfy these needs.”
This project is funded through a ‘Digitalisation and automation of medicines R&D and manufacture’ grant from Innovate UK.