CellFE, a leader in microfluidics-based cell engineering, and Made Scientific, a prominent cell therapy contract development and manufacturing organization (CDMO), announced a strategic collaboration aimed at advancing non-viral gene editing technologies for T cell therapies. The partnership, announced on May 13, 2025, will focus on generating pilot data using CellFE's innovative High Volume Cyva™ System.
The collaboration addresses critical challenges in cell therapy manufacturing, including high production costs and lengthy timelines that currently limit patient access to these potentially life-saving treatments.
Dual Manufacturing Workflow Approach
The pilot program will evaluate two distinct manufacturing workflows with significant implications for the future of cell therapies.
The first workflow targets activated T cells, combining both non-viral and viral gene editing techniques to rapidly produce personalized autologous T cell products. This approach directly addresses the growing demand for customized immunotherapies tailored to individual patient needs.
"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.
The second workflow represents a more novel approach, focusing on quiescent or resting T cells. This initiative aims to demonstrate the first proof of concept for a viable allogeneic resting T cell therapeutic approach—potentially unlocking new "off-the-shelf" cell therapy solutions that could dramatically expand access and reduce time-to-treatment for patients.
Technology and Expertise Synergy
Under the agreement, CellFE has selected Made Scientific to conduct pilot-scale studies using the High Volume Cyva™ System. The collaboration leverages Made Scientific's advanced manufacturing capabilities and extensive expertise in cell therapy process development.
The partnership aims to demonstrate that CellFE's microfluidics platform can maintain superior cell health, maximize yields, and enable complex genome editing without viral vectors—addressing key industry challenges related to scalability, cost, and production timelines.
Syed T. Husain, Chairman & CEO at Made Scientific, highlighted the significance of the partnership: "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."
Implications for Cell Therapy Development
The non-viral gene editing approach being developed through this collaboration could potentially transform how cell therapies are manufactured. Traditional viral vector-based methods face limitations in terms of manufacturing complexity, cost, and safety considerations.
CellFE's microfluidics-based gene delivery technology aims to streamline manufacturing processes for T-cell, hematopoietic stem cell (HSC), and induced pluripotent stem cell (iPSC) therapies—all critical platforms in the rapidly evolving cell therapy landscape.
Made Scientific brings crucial expertise as a CDMO that has specialized in developing, manufacturing, and releasing both autologous and allogeneic cell therapy products since 2019. Operating from two U.S.-based manufacturing facilities, the company combines specialized CDMO capabilities with the global resources of its parent organization, GC Corporation of South Korea.
Future Developments
The results of this pilot program will be compiled into a comprehensive white paper scheduled for presentation to the cell and gene therapy community by October 2025. This document is expected to provide valuable insights into the scalability and robustness of non-viral gene editing approaches for T cell therapies.
If successful, this collaboration could help establish new manufacturing standards that address current bottlenecks in cell therapy production, potentially accelerating the delivery of these advanced treatments to patients worldwide.
