CGT Catapult Launches ReCell Consortium to Develop Universal Safety Tests for Cell Therapies
Key Insights
CGT Catapult (search) has established ReCell (search), a 13-partner consortium aimed at developing universal safety tests to detect residual pluripotent stem cells (search) in cell therapy products.
The consortium will evaluate two droplet digital PCR methods across eight different therapy products to address the current lack of standardized testing approaches.
Universal testing could significantly reduce development costs and timelines while ensuring safer cell therapies reach patients more quickly.
CGT Catapult (search), an independent technology organization specializing in cell and gene therapy, has launched ReCell (search), a 13-partner consortium designed to develop universal safety tests for detecting residual pluripotent stem cells (search) (PSCs) in cell therapy products. The initiative addresses a critical safety challenge that currently requires each developer to create individual product tests at considerable time and expense.
Addressing Critical Safety Concerns
Pluripotent stem cells (search) offer significant therapeutic potential across multiple applications, including cell replacement and regeneration, adaptive or genetically modified interventions, and targeted therapeutic approaches. Their capacity to differentiate into many clinically relevant cell types makes them valuable for advanced therapies. However, the presence of undifferentiated PSCs in therapeutic products poses a serious safety risk, potentially causing uncontrolled proliferation and tumor formation (search).
Currently, no universal test exists for drug developers to ensure their products are free from residual PSCs. This gap forces each developer to create their own individual product tests, a process that is both costly and time-consuming, ultimately lengthening development timelines for potentially life-changing treatments.
Consortium Structure and Testing Approach
The ReCell (search) consortium brings together diverse industry stakeholders, including regulators, therapy developers, contract development and manufacturing organizations (CDMOs), and a contract research organization (CRO). The 13 partners include Advent Bioservices, CGT Catapult (search), Cellistic, Curileum Discovery, the Medicines and Healthcare products Regulatory Agency (MHRA), Plasticell, Rinri Therapeutics, the Scottish National Blood Transfusion Service, Sistemic (search), SmartCella, StemSight, the University of Nottingham, and Xellera Therapeutics.
The consortium will evaluate whether two droplet digital PCR methods can effectively detect residual PSCs across eight different therapy products. The first test has been co-developed by CGT Catapult (search) and the Health and Environmental Sciences Institute's (HESI (search)) Cell Therapy Tracking, Circulation, and Safety committee. The second method, SistemPSCcheck (search), has been developed by biotechnology firm Sistemic (search) and is already commercially available for therapy developers.
Industry Impact and Regulatory Support
"The science behind cell therapies is advancing quickly, opening up real hope for people living with serious and rare conditions," said Lawrence Tallon, chief executive of the MHRA. "A universal test would help ensure these promising treatments reach patients sooner."
Matthew Durdy, chief executive of CGT Catapult (search), emphasized the potential impact of universal testing: "Universal tests for residual PSCs could help accelerate the development of safe and effective cell therapies. By working together with experts from Sistemic (search), MHRA, and a group of leading therapy developers, we hope to demonstrate how such tests could be applied to a range of products to reduce costs, shorten development timelines, and ensure life-changing advanced therapies are safe for patients."
The initiative aligns with broader industry calls for collaboration, particularly from the UK BioIndustry Association (BIA), which has identified industry fragmentation as a major barrier to patient access. This challenge is especially acute for patients with rare diseases (search) who face high levels of unmet medical need.