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.

英国Catapult公司获得了120万欧元(100万英镑)的总资助，该公司将利用阿喀琉斯公司开发的复杂的、与临床相关的肿瘤新抗原机械工具，率先开发拉曼软传感器和化学计量工具。阿喀琉斯公司还为该项目提供所有生物材料和细胞模型。技术将被转移到CGT弹射器上。

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."

“我们非常高兴能成为Smarter联盟的一部分，”La Fe医院生物标志物和精准医疗负责人Agustín Lahoz补充道。“该项目将向科学界和社会展示代谢组学如何成为一种有价值的工具，以找到特定的非侵入性生物标志物来监测细胞的生理状态。这可以用于加快生产过程，并提供特征更好的细胞，以最佳匹配的患者。This challenge is aligned with our commitment to developing new therapies to improve lung cancer treatment”

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