CGT Catapult, an independent technology organisation specialising in the cell and gene therapy (CGT) industry, has established ReCell, a consortium focusing on safety tests for a range of cell therapies.
Pluripotent stem cells (PSCs) can be used in a number of advanced therapies, such as cell replacement and regeneration, adaptive or genetically modified interventions, and targeted therapeutic approaches, as they have the capacity to differentiate into many clinically relevant cell types. However, there is also the risk that if there are any undifferentiated PSCs remaining in a therapy, this could cause uncontrolled proliferation and tumour formation.
There is currently no universal test that drug developers can use to ensure that products are free from residual PSCs, requiring each developer to create their own individual product tests. This is costly, and lengthens the amount of time a treatment is in development.
ReCell is a 13-partner consortium bringing together regulators, therapy developers, contract development and manufacturing organisations (CDMOs), and a contract research organisation (CRO) to address this issue. Its aim is to test whether two droplet digital PCR methods are able to detect residual PSCs in eight different therapy products.
“The science behind cell therapies is advancing quickly, opening up real hope for people living with serious and rare conditions,” Lawrence Tallon, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said. “A universal test would help ensure these promising treatments reach patients sooner.”
The first test has been co-developed by CGT Catapult and the Health and Environmental Sciences Institute’s (HESI) Cell Therapy Tracking, Circulation, and Safety committee. The second, SistemPSCcheck, has been developed by Sistemic, and is commercially available.
Matthew Durdy, chief executive of CGT Catapult, said: “Universal tests for residual PSCs could help accelerate the development of safe and effective cell therapies. By working together with experts from Sistemic, 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.”