CellFE, a leader in microfluidics-based cell engineering, and Made Scientific, a leading cell therapy contract development and manufacturing organization (CDMO),  announced a strategic collaboration to generate pilot data on the CellFE High Volume Cyva^™ System. This partnership will validate the clinical-scale performance of CellFE's innovative, non-viral gene editing microfluidics technology for both activated and resting T cell therapies.

The pilot program will evaluate two distinct manufacturing workflows. The first workflow will utilize activated T cells and combine both non-viral and viral gene editing techniques to rapidly produce autologous T cell products, addressing the critical demand for personalized immunotherapies. The second workflow will focus on quiescent or resting T cells, aiming to demonstrate the first proof of concept for a viable allogeneic resting T cell therapeutic approach. This approach has the potential to unlock new off-the-shelf cell therapy solutions, expanding access and reducing time-to-treatment for patients.

Under the agreement, CellFE has selected Made Scientific to conduct pilot-scale studies using the High Volume Cyva^™ System, leveraging Made's state-of-the-art manufacturing capabilities and deep expertise in cell therapy process development. The collaboration aims to demonstrate the scalability and robustness of CellFE's microfluidics platform, specifically designed to maintain superior cell health, maximize yields, and enable complex genome editing without the use of viral vectors. This novel approach addresses key industry challenges, including scalability, cost, and production timelines, to accelerate the delivery of advanced cell therapies to patients.

"By combining CellFE's breakthrough microfluidic gene editing with Made Scientific's world-class CDMO services, we are positioned to establish a new benchmark in engineered T cell therapy manufacturing," said Alla Zamarayeva, Ph.D., CEO and Co-founder at CellFE. "This collaboration will generate critical data to support the clinical translation of our technology at scale."

"This partnership with CellFE presents an incredible opportunity to advance innovative non-viral gene editing approaches," said Syed T. Husain, Chairman & CEO at Made Scientific. "By integrating our specialized T cell manufacturing platform expertise with CellFE's microfluidics technology, we are poised to significantly optimize quality and accelerate timelines while meeting the unique requirements of these groundbreaking therapies."

The results of this pilot program will be shared in a forthcoming white paper, to be presented with the cell and gene therapy community by October 2025.