CGT Catapult joins new Consortium to Advance Personalized Cell Therapy Manufacturing

London, 22 July 2022 – Cell and Gene Therapy Catapult (CGT Catapult) today announced the launch of a new consortium that will drive forward innovation and advancement in the manufacturing of personalised cell therapies.

The new consortium – led by UK ATMP developer Achilles Therapeutics and which also includes Leibniz University Hannover (Hannover) as project coordinator, and the Fundacion para la Investigacion del Hospital Universitario la Fe de la Comunidad Valenciana (Valencia) – has been awarded €4m (£3.5m) of funding by Horizon Europe, the European Union’s key funding program for research and innovation, toward the development of an innovative smart bioprocessing manufacturing platform (bioreactor) for personalized cell therapies.

At present, most existing manufacturing platforms are limited in their ability to provide sufficient real-time data during production, which in-turn limits proactive decision making and reduces overall scalability. This project – “Smart ManufactuRing for Autologous Cell ThERapies enabled by innovative biomonitoring technologies and advanced process control” (or “SMARTER”) - will advance the state-of-the-art in cell therapy manufacturing processes, by developing a first-in-class proof-of-concept “smart” bioprocessing manufacturing platform. The smart platform will be capable of analysing key biomarkers in real-time and adjusting aspects of the process accordingly, enabling the generation of drug product at a more consistent quality.

CGT Catapult will receive €1.2m (£1m) of the total funding to deliver this project through the Horizon Europe Guarantee scheme, and will use this amount to lead on the development of Raman soft sensors and chemometric models for on-line process biomarker monitoring. These technologies will be developed using sophisticated and clinically relevant tumour neoantigen mechanistic models, which will be developed by Achilles and tech transferred into CGT Catapult.

Other members of the consortium will identify critical process parameters and biomarker monitoring targets (Valencia) and develop 2D fluorescence spectroscopy sensors (Hannover). The CGT Catapult will then finally use our unique expertise in Process Analytical Technologies (PAT) and application of robotics and automation to bioprocessing systems to bring all this technology together and demonstrate a proof-of-concept device.

Matthew Durdy, Chief Executive Officer, of the CGT Catapult, commented:

“At the heart of our vision for a thriving cell and gene therapy sector is our work to make the manufacture of ATMPs safer, more efficient and more consistent. This project will be a hugely important step forward in this area, helping to improve scalability and reduce costs. We look forward to seeing how we can capture the lessons from this project and ensure that, in the long term, developers, clinicians and patients can benefit.”

Achilles Therapeutics will supply all biological material and cell models used during the project, with the new platform initially applied to tumour neoantigen samples and models supplied by the company (who are supplying all biological material and cell models).

Edward Samuel, EVP, Technical Operations at Achilles Therapeutics, commented:

“We are thrilled to be part of this consortium to support the continued innovation of cell therapy manufacturing processes. As a pioneer in the field of personalized cell therapies, we are excited to lend our expertise to this project which we believe can deliver significant benefits for patients.”

Sascha Beutel, Group leader at TCI, Leibniz University Hannover, commented:

"The SMARTER project will take advanced human T-cell manufacturing techniques a step further by improving the ability to monitor and control the process. As an academic partner with great expertise in online optical bioprocess monitoring, we are excited to be part of this project, which we believe will lead to an increase in knowledge and significant innovations in T-cell production - for the benefit of all patients in need of personalised T-cell therapy."

Agustín Lahoz, Leader of Biomarker and Precision Medicine at Hospital La Fe, commented:

“We are really excited to be part of the Smarter consortium. This project will show the scientific community and society how metabolomics can be a valuable tool to find specific non-invasive biomarkers to monitor cells´ physiological status. This could be used to speed up the manufacturing procedure and to deliver better characterized cells to best match them with the adequate patients. This challenge is aligned with our commitment to developing new therapies to improve lung cancer treatment”