Three-Way Collaboration Between Rentschler Biopharma, CGT Catapult, and Refeyn Aims to Improve PAT for Gene Therapy Manufacturing

Rentschler Biopharma announced a collaboration on Aug. 23, 2023 with Cell and Gene Therapy Catapult (CGT Catapult), a UK-based independent innovation and technology organization specializing in cell and gene therapies, and Refeyn, a UK-based provider of mass photometry instruments and technologies, under which the three organization will develop and apply innovative process analytical technologies (PAT) to improve the manufacturing process for adeno-associated viruses (AAVs) in gene therapy production.

Under this two-year collaboration, the partners aim to develop a digitized and automated AAV gene therapy manufacturing platform. Through a combination of expertise in manufacturing, process analytics, and PAT, the collaborators will develop automated monitoring and control that will then be applied to Rentschler Biopharma’s existing AAV manufacturing process.

Because current analytical methods related to AAV production mainly rely on manual sampling, the production of AAVs has been difficult and time consuming. However, over 65% of gene therapies in development currently rely on AAV vectors.

To address the AAV manufacturing challenges, the teams under this collaboration will carry out high throughput and automated sampling and analysis of AAV material throughout the production process. The data collected from this analysis will be used to create digital twins, which are digital models of the manufacturing process that can be used to further refine and improve the efficiency of the process.

Thus, using the digital twins, the teams can carry out initial tests on any changes to the manufacturing process in a digital environment. Troubleshooting in this fashion would reduce the number of expensive and time-consuming physical tests that otherwise would be needed to be carried out in the laboratory, according to a company press release.

The collaborators will assess any improvements in productivity and AAV yield using automated analytical technologies, which will include Refeyn’s technology to assess the proportion of full AAV capsids produced. Assessing the proportion of full AAV capsids produced is a key measurement for the industry; the quantity of full AAV capsids indicates process efficiency but may also impact clinical efficacy, according to the press release. Refeyn will additionally use this project to test a new current good manufacturing practice-compliant version of its mass photometer.

“With this collaborative project … we seek to unleash the potential of faster viral vector development with multi-parameter driven optimization,” said Christian Schetter, chief scientific officer, Rentschler Biopharma, in the press release. “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.”

“The outputs will help us understand the future needs of viral vector manufacturing environments, informing product development to better satisfy these needs,” said Matthias Langhorst, chief product officer, Refeyn, in the release.

The project is being funded through a grant from Innovate UK.

Source: Rentschler Biopharma