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.
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”
About Horizon Europe
Horizon Europe is the EU’s key funding program for research and innovation with a budget of €95.5 billion. It tackles climate change, helps to achieve the UN’s Sustainable Development Goals and boosts the EU’s competitiveness and growth. The program facilitates collaboration and strengthens the impact of research and innovation in developing, supporting and implementing EU policies while tackling global challenges. It supports creating and better dispersing of excellent knowledge and technologies.
For further information please visit Horizon Europe.
About the Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult is part of the Catapult Network. It was established by, and works in partnership with, Innovate UK.
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. With over 400 experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation. For more information, please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk.
Leibniz University Hannover
The Leibniz University Hannover is one of the largest and oldest science and technology universities in Germany. As one of the nine leading Universities of Technology in Germany (member of TU9 Alliance), Leibniz University Hannover is aware of its responsibility in seeking sustainable, peaceful and responsible solutions to the key issues of tomorrow. The Institute of Technical Chemistry offers a broad expertise on various bioprocess engineering areas in up- and downstream processing ranging from bacterial to human cellculture, enzyme application as well as bioanalytical monitoring and control.
Fundacion para la Investigacion del Hospital Universitario la Fe de la Comunidad Valenciana.
The Fundacion para la Investigacion del Hospital Universitario la Fe de la Comunidad Valenciana encourages, promotes and fosters cutting-edge investigation, scientific and technological knowledge and its further transfer to the production sector. The same holds true in its role in teaching and training in the Hospital and other primary care centres that fall under the “La Fe” Health Department. HULAFE was accredited by the Health Institute Carlos III (Ministry of Economy and Competitiveness) as a Health Research Institute in 2009, and again re-accredited in 2014. The HULAFE is formed by 47 multidisciplinary and complementary research groups that offer scientific and technological services in 10,000 m2 dedicated to clinical and research laboratories that undertake research programmes based on state-of-the-art biomedical science,
About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical company developing precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary AI-Powered PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.