Rentschler Biopharma, a leading global contract development and manufacturing organisation (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), announces a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of cell and gene therapies, and Refeyn Ltd., the Oxford based mass photometry pioneer. The collaborators will develop and apply innovative 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. 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 expertise 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 cGMP compliant version of its mass photometer.

Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, commented: “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, 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 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.

About the Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. The Cell and Gene Therapy Catapult works with Innovate UK. For more information, please visit https://ct.catapult.org.uk/ or https://www.ukri.org/councils/innovate-uk/.

FTI Consulting for the Cell and Gene Therapy Catapult:

Alexander Davis
+44 (0) 203 727 1729
Alexander.Davis@fticonsulting.com

George Kendrick
+44 (0) 203 727 1411
George.Kendrick@fticonsulting.com

About Refeyn

Refeyn pioneers analytical instruments that put molecular mass measurement capabilities within easy reach for scientists. Refeyn’s unique products measure the mass of individual proteins, nucleic acids, complexes and viruses – providing vital insights for scientific discovery, R&D and therapeutics production.

The instruments feature mass photometry technology, which uses light to quantify the mass of single particles in solution without labels. Providing intuitive data in minutes, mass photometry helps scientists solve their research questions, optimize R&D processes, and focus on innovation. For more information, please visit https://www.refeyn.com/

About Rentschler Biopharma SE

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, including adeno-associated virus (AAV) gene therapies, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,200 employees, headquartered in Laupheim, Germany, with a second site in Milford, MA, USA. Rentschler ATMP Ltd., located in Stevenage, UK, is dedicated to cell and gene therapies.

For further information, please visit www.rentschler-biopharma.com. Follow Rentschler Biopharma on LinkedIn and Facebook.

Contact:
Rentschler Biopharma SE
Dr. Latika Bhonsle-Deeng
Senior Director Corporate Communications
Phone: +49-7392-701-467
communications@rentschler-biopharma.com

Media inquiries:
MC Services AG
Eve Bauer
Phone: +49-89-210228-0
rentschler@mc-services.eu
U.S.
Laurie Doyle
Phone: +1-339-832-0752

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