Key findings
- CellFiber has introduced a GMP-compliant manufacturing system, the CellFiber Extruder, for large-scale cell fiber fabrication.
- It aims to streamline and standardize cell therapy manufacturing by using single-use components and compliance features that support closed processing and traceability.
Japan’s CellFiber has introduced a production-scale model of its GMP-compliant cell fiber fabrication system, the CellFiber Extruder, designed to scale cell manufacturing for regenerative medicine and cell therapy products.
Why CellFiber is building this
The industry faces ongoing manufacturing constraints, including complex processes, long production timelines, and high costs. CellFiber designed the extruder to support larger-scale, standardized production under GMP (Good Manufacturing Practice) expectations, with a focus on stable processing and reduced manual handling.
What CellFiber technology is
It works by encapsulating cells within a tubular structure made of medical-grade alginate (a polysaccharide commonly derived from seaweed and used in biomaterials), creating a high-density cell culture environment. It’s also paired with a dedicated single-use kit and reagent set.
The company says the approach supports functional maintenance, long-term viability, and consistency compared to conventional methods.
Key features
- Automation: Streamlines cell fiber production for large-scale cultures, with the goal of reducing manufacturing time.
- Flexibility: Compatible with suspension and adherent cell cultures, upstream and downstream processes, and multiple types of culture vessels.
- Closed system: Uses a single-use kit intended to reduce contamination risk from manual handling and the surrounding environment.
- Traceability: Includes monitoring logs, access control, and audit trails intended to support regulatory requirements.
The system is designed for a 5-liter scale culture, with target yields of
- Adherent cells: 109 cells per set
- Suspension cells: 1010 cells per set
Product specs
- Dimensions: W: 699 mm × D: 565 mm × H: 1380 mm
- Weight: 128 kg
- Power requirements: 95-125 VAC, 50/60 Hz, 200VA
- Built-in PC OS: Windows 10
- Connectivity: 1 USB slot, 1 Ethernet port
- Regulatory compliance: GAMP5, 21 CFR Part 11
Single-use kit and reagent set
The single-use kit includes sterile connectors for aseptic connection with reagents, plus a final line made of compatible materials for connecting culture bags using sterile connectors. The company also notes that kits for adherent and suspension cell cultures are available.
The company added that the CellFiber Extruder Single-Use System meets USP 1043 and ISO 20399:2022, and cites ISO 11137 as a sterilization standard.
More information: https://cellfiber.jp/en/
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