Background
As we enter the era of precision medicine, cell and gene therapies (CGT) represent a medical breakthrough in treating many conditions. CGT are a totally new class of ‘living drugs’ that will radically reshape medical treatment.
Highly personalised chimeric antigen receptor T-cell (CAR T) therapies were introduced in the clinic a decade ago, with remarkable results in patients suffering from previously incurable blood cancers. As more CAR T treatments enter clinical trials, there is a rapid increase in demand for clinical-grade cell products. Beyond CAR T, there is a wealth of other cell-based treatments leveraging immune cells, induced pluripotent stem cells, and other cell types, with the promise to address solid tumours and other diseases indications beyond cancer. To reach their full potential, highly personalised CGT products require radical innovation, in technological and clinical development, but also in rethinking the healthcare system. Novel approaches will be key to effectively overcoming the challenges currently limiting access. Solutions are needed to increase accuracy/specificity, to scale up the production capacity or to speed up release tests that must be realised before wide clinical rollout for patient use.
In particular, current CGT manufacturing methods suffer from an important technological bottleneck by still relying on manual labour in centralised clean room facilities. This lack of process scalability results in low throughput, high costs, and ultimately limited global production capacity preventing many patients from accessing this next generation of therapies.
Cell & Gene Therapy Helix
The CGT Helix is an international Open Innovation community of experts in Cell & Gene Therapy and related disciplines. The Helix was launched as a driver focus for impact, exploitation and dissemination services in support of the entire CGT community aiming at making highly personalised CGT broadly available to patients by improving its production and manufacturing.
Increasing the number of patients receiving a highly personalised CGT treatment requires innovation and coordination beyond manufacturing alone. The CGT Helix is a place to expand the scope of innovation to the entire value chain, including the discovery of new modalities, and addressing new diseases, but also solving the challenge of reimbursement. This Helix provides a privileged Open Innovation platform for experts seeking international collaborators to carry out research and innovation, pre-clinical & clinical development to inform the creation of a next-gen CGT discovery platform.
Key Project
The CGT Helix is an initiative stemming from the project “Automated online monitoring & control to improve processes and decision-making in cell and gene therapy manufacturing” (PAT4CGT). PAT4CGT is a 36-month project funded by the European Innovation Council in the context of the EIC Pathfinder challenge: Emerging technologies in cell and gene therapy. PAT4CGT aims to develop a miniaturised analytical platform tailored for cell & gene therapy manufacturing, enabling the automated and non-invasive monitoring of critical process parameters. By combining state-of-the-art sensors, a novel bioreactor design and predictive data intelligence, the innovative solution will provide actionable information, paving the way for in-process control to produce highly personalised cell therapy treatments.
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the granting authority. Neither the European Union nor the granting authority can be held responsible for them. This project has received funding from the European Union’s Horizon 2020 or Horizon Europe research and innovation programme under grant agreement No 101070922.
Funded by
the European Union
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Thaís Soares
“The key challenge for Cell and Gene Therapy is to make highly personalised treatments broadly available to patients with innovation across the entire value chain. I am thrilled to lead the CGT Helix towards making this vision reality.”
