European Consortium to Advance Cell Therapy Manufacturing

CGT Catapult has joined a new consortium - led by UK ATMP developer Achilles Therapeutics and which includes Leibniz University Hannover (Hannover) as project coordinator and the Fundacion para la Investigacion del Hospital Universitario la Fe de la Comunidad Valenciana (Valencia) – with the goal of developing a smart bioprocessing manufacturing platform (bioreactor) for personalised cell therapies.

This project – “Smart ManufactuRing for Autologous Cell ThERapies enabled by innovative biomonitoring technologies and advanced process control” (or “SMARTER”) -  has been awarded €4m (£3.5m) of funding by Horizon Europe, the European Union’s key funding program for research and innovation.

With most existing manufacturing platforms limited in provision of sufficient real-time data during production, restricting proactive decision making and overall scalability, SMARTER aims to analyse  key biomarkers in real-time, adjusting aspects of the process accordingly and enable the generation of drug product at a more consistent quality.

The UK Catapult, which receives €1.2m (£1m) of the total funding will lead on development of Raman soft sensors and chemometric tools using sophisticated and clinically relevant tumour neoantigen mechanistic tools developed by Achilles, which is also supplying all biological materials and cell models for the project. The tech will be transferred into CGT Catapult.

The team at Valencia will identify critical process parameters and biomarker monitoring targets while researchers at Hannover will develop 2D fluorescence spectroscopy sensors. Process Analytical Technologies (PAT) and application of robotics and automation to bioprocessing systems, will then be applied by CGT to bring the technology together and demonstrate a proof-of-concept device.

Matthew Durdy, Chief Executive Officer, of the CGT Catapult, said: “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.”

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 personalised 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 said: "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."

“We are really excited to be part of the Smarter consortium,” added Agustín Lahoz, Leader of Biomarker and Precision Medicine at Hospital La Fe. “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 characterised 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”

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