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A large, modular SKAN "Cellana" isolator for ATMP processing, featuring a control touchscreen, material airlocks, and a central workstation with four integrated glove ports.
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Isolators

Cellana-M

Flexible isolator solution for maximum process safety in ATMP production

Application type
Aseptic
Customization level
Modular configuration
Cellana-M at a glance

Modular isolator for the safe processing of Advanced Therapy Medicinal Products (ATMPs)

  • Highest sterility assurance levels

    Complete separation between the Grade A process environment and the operator

  • Fastest decontamination cycles

    Automated >6-log H₂O₂ decontamination enables extremely short cycle times for time-sensitive products

  • Modular design

    Various chamber configurations and glove options allow optimal adaptation to your process

  • Flexible equipment integration

    Seamless integration of centrifuges, CO₂ incubators, microscopes, and other process equipment

  • Multiple transfer options

    Fast and secure transfer of materials and liquids

  • All processes on a single platform

    Full process workflows can be executed on one platform without open transfers

  • Integrated process controls

    Continuous, documented environmental monitoring and process control

  • Reduced operating costs

    Lower monitoring effort as well as reduced gowning and energy costs

Application

A safe environment for ATMPs

  • icon produkte

    For preclinical and clinical studies

    Cellana-M has been specifically developed to produce cell, tissue, and gene therapies such as CAR-T, iPSCs, and MSCs. It provides a controlled and reproducible environment for both preclinical and clinical applications.

  • For upstream and downstream processes

    Cellana-M covers all steps from cell modification and expansion to final formulation. Its design allows integration of various process equipment, enabling complex workflows to be executed efficiently and in a standardized way.

  • For aseptic filling of ATMPs

    For final product preparation, Cellana-M can be combined with filling systems. This makes it suitable for the sterile filling and packaging of sensitive cell and gene therapy products into vials, bags, or other primary containers.

An open industrial centrifuge integrated into a stainless steel workstation, featuring four buckets with yellow-tinted protective lids.
Process

Optimized cell culture and expansion: from thawing to harvest within Grade A

  • 1

    Cell thawing and transfer

    The process starts with the sterile transfer of cryo vials via the integrated airlock. Validated >6-log H₂O₂ decontamination is completed within minutes. Adapted cycle programs are available for sensitive materials.

  • 2

    Inoculum preparation and centrifugation

    The inoculum is prepared and processed using the integrated centrifuge. This can be configured flexibly up to 4 × 1000 mL, with a temperature range from –20°C to +40°C. Since all steps take place in the isolator, transfers between cleanroom zones are eliminated.

  • 3

    Cell culture and expansion

    The expansion occurs in integrated or removable CO₂ incubators. The stainless-steel interior is H₂O₂-compatible. Temperature and CO₂ levels are continuously monitored and recorded to ensure stable, reproducible growth conditions for sensitive cell cultures.

  • 4

    Harvest and formulation

    After expansion, cells are harvested, including washing and final formulation. Integrated pumping and filling systems enable a closed process chain. Continuous monitoring of environmental parameters ensures consistent product quality through to filling.

  • 5

    Aseptic filling

    The formulated cell suspension is then filled into final primary containers such as vials, syringes, or bags. Integrated or connected filling systems enable controlled, reproducible dosing without open handling steps.

Product highlights

A secure environment for tomorrow’s therapies

  • An open material airlock within a stainless steel SKAN isolator, containing sterile laboratory supplies like vials, bottles, and bagged equipment on wire shelving.

    Plug-and-play solution

    Cellana-M features a modular, customizable design tailored to your ATMP processes. At the same time, it is available as a standardized platform, ready for rapid deployment, significantly reducing lead times and commissioning effort.

  • A white Fresenius Kabi LOVO cell processing system integrated into a stainless steel medical isolator chamber from SKAN AG.

    Protection of product and operators

    The closed Grade A environment with dual HEPA filtration protects both sensitive ATMP processes and operating personnel. Configurable positive or negative pressure, combined with integrated H₂O₂ decontamination, ensures stable aseptic conditions.

  • **Alt-text:** A blue Pipetman laboratory pipette hanging on a stainless steel wire rack inside a sterile isolator environment, with a box of sample tubes in the background.

    Improved operational efficiency

    The use of isolator technology allows background cleanroom requirements to be reduced to Grade C/D. Lower gowning requirements simplify daily operations, improve working conditions, and reduce operating costs.

Regulatory requirements

Compliance with the most stringent GMP standards

  • Highest sterility assurance

    Cellana-M meets GMP requirements for ATMPs and achieves a sterility assurance level (SAL) of 10⁻⁶, significantly higher than the typical 10⁻³ of microbiological safety cabinets. Automated decontamination and reproducible processes ensure full traceability.

  • Risk reduction

    Regulatory guidelines such as PIC/S Annex 2A highlight the risks of open processing. Cellana-M fully separates the process from the operator, reducing human error. It also minimizes the risk of cross-contamination between batches and different products.

  • Digital compliance

    Integrated control systems ensure monitoring, operation, and documentation in compliance with 21 CFR Part 11. Complete digital records replace manual logs, ensuring data integrity.

**Alt-text:** View of an empty, high-grade stainless steel incubator or pass-through chamber with adjustable shelves, integrated into a sterile isolator system.

Technical specifications

  • Flexible chamber size

    1000 × 800–1250 × 750–1200 mm (W × H × D)

  • Size: Four-glove chamber

    2175 × 2488 × 1200 mm (W × H × D)

  • Weight: Four-glove chamber

    2200 kg

  • Airlocks

    Various H₂O₂ decontamination airlocks

  • Rapid Transfer Ports (RTP)

    H₂O₂ RTP and alpha/beta RTP systems

  • AT-Port

    For sterile liquid transfers

  • Incubator

    Integrated or removable, available in different sizes

  • Centrifuge

    1 L to 4 L

  • Additional process integrations

    For example, peristaltic pumps, microscopes, etc.

FAQs

    • Lower cleanroom requirements (Grade C/D instead of Grade B) reduce energy consumption and HVAC costs
    • Reduced need for protective garments lowers waste generation
    • Lower air consumption due to recirculated airflow (approx. 250 m³/h vs. 2000 m³/h for BSCs)

  • SKAN has developed solutions to address the risk of H₂O₂ penetration and to ensure compliance with critical thawing timelines. Fast transfer processes and decontamination cycles specifically designed for sensitive materials minimize these risks. This can be demonstrated and validated through dedicated testing.

  • Yes. The modular platform is designed to allow further integrations without difficulty, enabling adaptation to specific process requirements.

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