Production isolator Cellana-M

asepticfor biopharmaceutical applicationsfor cellular therapy

Overview
Flexible isolator solution designed for aseptic ATMP production, enabling closed workflows from thawing to filling within a Grade A environment.

Key features

• 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 specific processes.
• Flexible equipment integration: seamless integration of centrifuges, CO₂ incubators, microscopes and other process equipment.
• Multiple transfer options: H₂O₂ decontamination airlocks, Rapid Transfer Ports (RTP), alpha/beta RTP systems and AT-Port for sterile liquid transfers.
• All processes on a single platform: full workflows from thawing to filling can be executed within the isolator without open transfers.
• Integrated process controls: continuous, documented environmental monitoring and process control (digital records).
• Reduced operating costs: lower gowning and energy requirements through isolator technology, enabling background cleanroom downgrade to Grade C/D.

Applications

• Preclinical and clinical studies for cell, tissue and gene therapies such as CAR‑T, iPSCs, MSCs.
• Upstream and downstream processes covering cell modification, expansion and final formulation.
• Aseptic filling of ATMPs into vials, bags or other primary containers; compatible with integrated or connected filling systems.

Process workflow (summary)

• 1. Cell thawing and transfer: sterile transfer of cryo vials via integrated airlock with validated fast H₂O₂ decontamination cycles; adapted programs for sensitive materials.
• 2. Inoculum preparation and centrifugation: integrated centrifuge configurable up to 4 × 1000 mL, temperature range –20°C to +40°C; all steps performed inside the isolator to eliminate open transfers.
• 3. Cell culture and expansion: integrated or removable CO₂ incubators with stainless-steel, H₂O₂-compatible interiors; continuous monitoring and recording of temperature and CO₂.
• 4. Harvest and formulation: washing, formulation and transfer using integrated pumping and filling systems to maintain a closed process chain.
• 5. Aseptic filling: controlled, reproducible dosing into final containers (vials, syringes, bags) without open handling steps.

Product highlights

• Plug-and-play solution: modular, customizable design available as a standardized platform to reduce lead times and commissioning effort.
• Protection of product and operators: closed Grade A environment with dual HEPA filtration, configurable positive/negative pressure and integrated H₂O₂ decontamination.
• Improved operational efficiency: reduced monitoring effort, simplified gowning and better working conditions.

Regulatory requirements

• Designed to meet stringent GMP standards for ATMP production; sterility assurance level (SAL) of 10⁻⁶.
• Risk reduction through full separation of process and operator, minimizing human error and cross-contamination risks.
• Digital compliance: integrated control systems supporting monitoring, operation and documentation in compliance with 21 CFR Part 11 (complete digital records).

Technical characteristics / specifications

• Application type: Aseptic.
• Customization level: Modular configuration.
• Flexible chamber size (general): 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.
• Automated decontamination: validated >6-log H₂O₂ decontamination for chambers and airlocks.
• Airlocks: various H₂O₂ decontamination airlock options.
• Rapid Transfer Ports (RTP): H₂O₂ RTP and alpha/beta RTP systems available.
• AT-Port: for sterile liquid transfers.
• Centrifuge options: configurations from 1 L to 4 L; configurable up to 4 × 1000 mL with temperature range −20°C to +40°C.
• Incubator: integrated or removable incubators available in different sizes; stainless-steel interior compatible with H₂O₂.
• Additional process integrations: peristaltic pumps, microscopes and other equipment can be integrated.