A European consortium has launched EASYGEN, a project to develop an automated, modular platform for decentralised manufacturing of CAR T-cell therapies at hospitals. The project is supported by €8 million in funding from the EU’s Innovative Health Initiative (IHI).
Led by Fresenius, the consortium brings together 18 academic, research, clinical and industry partners from eight European countries, including Charles River, Cellix, Pro-Liance Global Solutions, TQ Therapeutics and Philips Electronics Nederland.
The partners aim to develop a hospital-based manufacturing platform that can reduce CAR T production time to less than 24 hours and lower treatment costs. The modular system is intended to integrate manufacturing, quality control and other process steps into a streamlined workflow close to the patient.
The project builds on technology developed by Fresenius Kabi’s Cell and Gene Therapy team. Charles River will contribute 3D screening technologies for early safety and efficacy testing, while Cellix’s Inish Analyser will be used to measure cell viability and cell numbers for quality control.
CAR T therapies require a patient’s T cells to be genetically modified to target cancer cells. Their production is currently complex and time-consuming and often relies on specialised manufacturing facilities, which can create logistical and capacity constraints.
EASYGEN aims to develop a flexible “one-stop” manufacturing solution that can be integrated into hospitals capable of performing leukapheresis. The modular platform could also potentially be adapted for other advanced therapy medicinal products (ATMPs), including therapies targeting solid tumours.
Read more about EASYGEN
Bron: European Pharmaceutical Review