Shibuya Corp. is showcasing its Cell Processing Isolator CPi, an isolator-based system designed to support aseptic cell culture and processing for regenerative medicine and cell therapy manufacturing.
The CPi system is intended to provide Grade A/ISO 5 particulate air quality environments within a broader cell processing center. Shibuya says the system helps manufacturers reduce direct human intervention during aseptic processing. The system can support cell culture and cell processing in a separative isolator environment, with the goal of improving contamination control, patient safety and operational efficiency.
In conventional cell processing center layouts, the facility itself may require more extensive cleanroom infrastructure, gowning areas and environmental controls. The isolator-based CPi approach can allow the surrounding cell processing center to operate at Grade C or, where regulations allow, Grade D. That configuration can thus reduce facility complexity, gowning requirements, space demands and energy use compared with more traditional manned cleanroom approaches.
The system separates cultured cells from operators during processing, reducing one of the major sources of contamination risk in aseptic manufacturing. Shibuya said the approach can also help lower validation workloads, operating costs and the risk of product loss linked to contamination events.
To support cell culture and processing workflows, CPi can be configured with ancillary systems for closed, aseptic handling. Available options include an aseptically mounted and removable incubator for cell culture, electronic sensors for product traceability, a built-in centrifuge with vaporized hydrogen peroxide decontamination, and video imaging microscopes for assessing cell morphology and viability inside the isolator.
The system also includes receiving sections and isolator pass boxes for transferring sterile materials between the isolator and surrounding environment. Work tracking and control systems are available to support product segregation, traceability and process documentation.
CPi systems incorporate Shibuya’s HYDEC vaporized hydrogen peroxide decontamination technology. The systems can also be equipped with configurable, menu-driven process control software to manage and document operations. Additional options include manufacturing management systems, SOP support systems, environmental monitoring for the facility and isolator, remote maintenance, equipment maintenance management and validation support.
Shibuya said its isolator technology experience in pharmaceutical and biopharmaceutical manufacturing helped inform the development of the CPi platform more than 15 years ago. The company said CPi systems have been installed globally and used to process multiple cell types, including induced pluripotent stem cells and autologous stem cells. Applications include laboratory research, cell therapy development and clinical-scale manufacturing.
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