As cell-based therapeutic and regenerative medicine manufacturing continues to expand, pharmaceutical and biotechnology companies are increasingly seeking improved aseptic manufacturing technologies that strengthen microbiological process control, enhance scalability, and reduce the high operational costs associated with traditional cleanroom facilities. Shibuya Corporation has successfully marketed its Cell Processing Isolator “CPi,” which achieves these objectives. CPi’s are highly advanced aseptic processing solutions engineered to simplify high output cell therapy manufacturing while maintaining exceptional contamination control.
Traditional Cell Processing Centers (CPCs) often require extensive cleanroom infrastructure, specialized gowning procedures, and significant energy consumption to maintain compliant manufacturing environments. Shibuya’s CPi system takes a different approach by creating fully enclosed Grade A/ISO 5 aseptic environments within comparatively low interior volume isolator technology platforms, this allows manufacturers to eliminate the large-scale cleanroom spaces without compromising sterility assurance or patient safety.
Designed specifically for regenerative medicine and cell therapy applications, the CPi isolates cultured cells from direct operator interaction, helping eliminate one of the primary sources of contamination in aseptic processing. This fully separative design improves contamination control while supporting higher product yields, reduced risk of product loss, and more consistent manufacturing performance across sensitive cell culture and processing operations.
The flexibility of the CPi platform allows manufacturers to support a variety of workflows ranging from laboratory research and process development, clinical-scale manufacturing and commercial manufacturing at the individual hospital scale. . Multiple independent isolators can operate within a larger CPC environment, enabling scalable production while simplifying facility design requirements. In many applications, facilities may operate within Grade C (ISO 7) or (ISO 8) Grade D environments where regulations permit, helping reduce initial construction costs and ongoing operational expenses.
To achieve and maintain fully separative aseptic processing, the system can integrate ancillary technologies including incubators for cell cultivation, built-in centrifuges for cell expansion processes, imaging microscopes for cell viability assessment, and pass box systems for secure material transfer. These integrated capabilities help manufacturers maintain product traceability, process consistency, and operational efficiency throughout the production cycle.
Shibuya’s proprietary HYDEC vaporized hydrogen peroxide decontamination technology further enhances aseptic assurance by enabling effective decontamination of the isolator and internal components between production runs. Configurable process control systems, environmental monitoring integration, SOP support systems, and manufacturing management tools provide additional layers of process visibility, compliance support, and operational control for advanced cell therapy manufacturing environments.
Operational efficiency remains a key advantage of the CPi platform. By reducing cleanroom complexity and minimizing manual intervention, it lowers energy consumption, shortens validation timelines, and reduces gowning requirements, while also optimizing product output and enabling lower long-term operating costs. These benefits make isolator-based aseptic processing an increasingly attractive solution for companies scaling regenerative medicine and cellular therapy production.
Backed by more than 35 years of pharmaceutical isolator expertise, Shibuya has spent over 15 years developing CPi systems for advanced cell processing applications. Installed globally for a variety of stem cell and regenerative medicine workflows, the technology continues to support manufacturers seeking safer, more flexible, and cost-effective approaches to aseptic cell therapy production.
For more information about Shibuya’s Cell Processing Isolator “CPi,” visit Shibuya CPi Systems.