Rentschler Biopharma agreed to collaborate with Cell and Gene Therapy Catapult and Refeyn to develop and apply novel process analytical technologies (PAT) to improve the process and efficiency of AAV manufacture.

Over 65% of gene therapies in development currently are based on AAV, according to a Rentschler official, who adds that 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 digitized and automated AAV gene therapy manufacturing platform. By combining their expertise in manufacturing and process analytics with PAT, they plan to develop automated monitoring and control, which will be applied to Rentschler Biopharma’s existing AAV manufacturing process.

High throughput and automated sampling

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, i.e., 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 perform 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.

The teams 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. Matthias Langhorst, PhD, chief product officer at Refeyn, notes that this is a key measurement for the industry, as quantity of full AAV capsids not only indicates process efficiency but may also impact clinical efficacy. Refeyn will also use the project to test its new cGMP compliant version of its mass photometer.

“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,” adds Matthew Durdy, chief executive of CGT Catapult. “We expect the collaboration to make a significant contribution to enhanced manufacturing capability for the industry.”

 “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,” says Christian Schetter, CSO, Rentschler Biopharma. “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.”

This project is funded through a “Digitalization and automation of medicines R&D and manufacture” grant from Innovate UK.

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