PRO-LIANCE GLOBAL SOLUTIONS Joins the EASYGEN Consortium to Bring CAR-T Therapy Closer to Patients

Today, CAR-T therapy stands as one of the most groundbreaking advances in cancer treatment. However, fewer than 20% of eligible patients currently receive this life-saving therapy—primarily due to the centralized, complex, and time-consuming nature of its manufacturing process.

This needs to change. We are proud to announce that PRO-LIANCE GLOBAL SOLUTIONS has joined the newly launched EASYGEN (Easy workflow integration for gene therapy) consortium—an ambitious, multinational collaboration aimed at transforming CAR-T manufacturing from a week-long, manual process into a fully automated, 24-hour, point-of-care solution.

The EASYGEN project brings together 18 leading organizations from 8 countries, combining expertise across biotechnology, automation, clinical research, and regulation. Together, the consortium seeks to decentralize CAR-T production, drastically cut costs, remove logistical bottlenecks, and expand timely access to personalized immunotherapy for cancer patients across Europe and beyond.

As a member of the consortium, PRO-LIANCE GLOBAL SOLUTIONS will ensure that the device used for automated manufacturing meets all applicable regulatory requirements, including full compliance with the EU Medical Device Regulation (MDR) and the advanced therapy medicinal product (ATMP) regulation. This involves not only securing regulatory approvals for clinical use but also designing initial clinical trials to demonstrate the system’s safety, efficacy, and reliability in real-world settings.

The regulatory framework for ATMPs, especially for decentralized, point-of-care (PoC) manufacturing is shaping and PRO-LIANCE GLOBAL SOLUTIONS will actively contribute to the evolution of the EU’s regulatory pathways — helping to identify regulatory gaps and engage in constructive dialogue with responsible EU bodies to establish new regulations and processes for the next generation of cell and gene therapies.