The Fraunhofer Institute for Cell Therapy and Immunology IZI and PlasmidFactory GmbH aim to jointly advance innovative and efficient manufacturing processes for cell and gene therapies. The Fresenius-led EASYGEN consortium is appearing as the first official cooperation partner within this strategic collaboration.

The European IHI project EASYGEN aims to shorten the production time of CAR-T cells – from the current several weeks to 24 to 48 hours. "A decentralized manufacturing platform directly at treatment centers, the point-of-care, would make the processes more efficient and economical. Our goal is to enable access to CAR-T therapies for significantly more patients in the future," summarizes Dr. Sonja Steppan, Head of Research Office & Principal Investigator EASYGEN, Fresenius SE & Co. KGaA, Bad Homburg. The decision to also rely on non-viral methods, such as minicircle technology, is a crucial step toward the desired process optimization.

Point-of-Care Setting Enabled by PlasmidFactory's Minicircle Technology

The EASYGEN consortium is utilizing PlasmidFactory GmbH's minicircle technology to develop a virus-free, safe, and efficient manufacturing process for CAR-T cells – as a high-quality alternative to current manufacturing methods, which rely on viral vectors and accordingly require high safety standards and incur high costs. Minicircles no longer contain a classical plasmid backbone and completely dispense with functional bacterial elements, so they consist solely of the DNA sequences relevant for the application. As a result, they are smaller and more efficient, enable improved transfection and expression, and are therefore particularly suitable for virus-free approaches. Thus, PlasmidFactory's minicircle technology forms a central basis for implementing the virus-free manufacturing approach in the EASYGEN project. PlasmidFactory is a German CDMO with many years of experience in plasmid and minicircle manufacturing.

At Fraunhofer IZI, methods for the virus-free generation of CAR-T cells using PlasmidFactory's minicircle technology have already been established and successfully implemented in preclinical settings, in clinical translation, and in the manufacturing of clinical CAR-T products. This technology thus represents a key component within EASYGEN. For this purpose, PlasmidFactory provides two specialized minicircle variants that significantly contribute to the development and validation of the shortened manufacturing process in the planned point-of-care setting. The biotech company T-CURX GmbH, also part of the consortium, supports the project with its expertise in optimizing the virus-free manufacturing process.

The use of virus-free methods also addresses key challenges of current cell therapy production, such as economic efficiency, scalability, and process logistics.

As a first step, a workshop of the EASYGEN consortium has already taken place at Fraunhofer IZI to test the developed EASYGEN protocol for manufacturing CAR-T cells for the first time – using PlasmidFactory's minicircle technology.

About the EASYGEN Initiative

The EASYGEN consortium is led by Fresenius with the support of Fraunhofer IZI as the academic co-coordinator under the leadership of Prof. Dr. Dr. Ulrike Köhl and Prof. Dr. Michael Hudecek. The consortium comprises 21 organizations from nine countries, including leading companies such as Fresenius SE & Co. KGaA, Fresenius Kabi, Helios, Quirónsalud, Fenwal, Cellix, Charles River, Pro-Liance, TQ Therapeutics, and Philips, as well as renowned research and scientific institutions such as Fraunhofer IZI, Fraunhofer IESE, the Helmholtz-Zentrum Dresden-Rossendorf, the Technical University of Denmark, the Frankfurt School of Finance & Management, the EBMT, Bar-Ilan University, the University of Glasgow, and the University of Navarra. Fresenius has a broad presence in cell and gene therapy: Fresenius Kabi is developing medical technology solutions such as the automated cell processing systems Lovo and Cue. Since 2019, Helios has been offering CAR-T therapies as standard treatment at Klinikum Berlin-Buch and conducts clinical studies for this purpose. Quirónsalud has specialized oncology centers that use CAR-T therapies, particularly for hematological diseases.
For more information see: www.easygen-consortium.eu