Thermo Fisher Scientific has launched a modular, closed cell therapy processing system, Gibco CTS Rotea Counterflow Centrifugation System, which aids in scalable, cost-effective cell therapy development and manufacturing.
The modular system is the first Gibco instrument that enables workflows from research to GMP clinical development and commercial manufacturing.
According to the data from the Alliance for Regenerative Medicine, 675 clinical trials are progressing for cell therapy and cell-based immune-oncology around the world.
However, few of these developing cell therapies reach the commercial stage due to many factors.
These factors include safety and efficacy requirements, difficulties in transferring research protocols to manufacturing processes, lack of scalability, high cost, labour and equipment, as well as the complexity of the processes.
A modular, closed system for cell processing enables decoupling of time-consuming processes from rapid processes, improving facility and equipment usage and cutting costs.
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Using CTS Rotea system from research through process development and commercial manufacturing reduces process delays associated with changing systems.
The use of sterile, closed, single-use kits aid cell processing in grade C clean rooms, enabling cost-effective transfer and scale-out of processes.
Thermo Fisher Scientific biosciences business president Amy Butler said: “Our goal is to help advance the development of cell therapies, including exciting new CAR T cell therapies and even potential cell therapies to repair lung damage caused by Covid-19.
“The CTS Rotea system will help researchers overcome manufacturing hurdles and bring the vast potential of cell therapies to more patients.”
Designed to integrate effortlessly into existing workflows, the multifunctional system processes low to mid-range input volumes and deliver low output volumes.
The system has an instrument, closed sterile single-use kit and user-programmable software.
It can support a broad range of protocols for cell separation, washing and concentration with a cell recovery yield of over 95%.