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The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.
Thermo Fisher Scientific has launched Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. The system is the first Gibco instrument for cell therapy processing applications, the company announced in an Oct. 15, 2020 press release. The CTS Rotea system facilitates workflows from research through to good manufacturing practice (GMP) clinical development and commercial manufacturing.
A modular, closed cell processing system enables time-consuming processes to be decoupled from rapid processes, which improves the utilization of both equipment and the manufacturing facility, thus reducing the capital investment required for cell therapy manufacturing operations, according to the company. Furthermore, use of the same system from research through to process development and commercial manufacturing lowers the risk of process delays associated with changing systems. Sterile, closed, single-use kits enable cell processing in grade C clean rooms, which can lead to cost-effective transfer and scale-out of processes.
With 675 clinical trials underway globally for cell therapy and cell-based immune-oncology as of mid-2020, according to the Alliance for Regenerative Medicine, there are yet few cell therapies in development that become commercially available. This is due to several factors: safety and efficacy requirements, difficulties in transferring research protocols to manufacturing processes, lack of scalability of these therapies, high cost of facilities, labor and equipment, and complexity of the processes involved, Thermo Fisher stated in the press release.
The CTS Rotea system, which is multifunctional and highly flexible, can easily integrate into existing workflows, process low- to mid-range input volumes, and deliver low output volumes. The system consists of an instrument, closed sterile single use kit, and user programmable software. It provides processing flexibility to support a broad range of protocols for cell separation, washing, and concentration. Cell recovery yield is greater than 95% and cell viability is maintained.
"It is notoriously difficult for cell therapies to advance from the research stage into the marketplace," said Amy Butler, president of the biosciences business at Thermo Fisher Scientific, in the press release. "Our goal is to help advance the development of cell therapies, including exciting new CAR T [chimeric antigen receptor T-cell] 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."
Source: Thermo Fisher Scientific