Cell and gene therapy modular isolator
Enhance your cell and gene therapy production with a modular isolator that integrates decontamination, isolation, and processing into a single compact design, allowing for flexible adaptations to scale production and maintain cleanroom standards efficiently.
Isolates, Processes, and Incubates Cell Therapy Products
The ValueCell COMBI from Comecer is a modular isolator tailored for the evolving needs of cell and gene therapy production. Its distinct multi-module design supports simultaneous isolation, processing, and incubation tasks, ensuring contamination control and precision in operations such as CAR-T cell and stem cell therapy production. Equipped for both modular and stand-alone operations, the system integrates seamlessly into existing production lines, supporting processes like decontamination, filling, and packing through its innovative configuration options.
With applications spanning biopharmaceuticals and ATMPs, the ValueCell COMBI efficiently handles products including monoclonal antibodies and genetically modified T-cells. Prioritizing energy efficiency and operator convenience, this isolator features integrated filling options and factory-floor management via the Illuminate™ Manufacturing Intelligence platform. Its robust construction adheres to stringent pharmaceutical standards, incorporating CIP systems for efficient cleaning. Customization is facilitated through interchangeable modules and scalable design, making it ideal for diverse operational needs in pharmaceutical, biotech, and regenerative medicine industries.
Benefits
- Enhances operational flexibility with customizable modular configurations.
- Minimizes contamination risk through advanced isolation and decontamination processes.
- Streamlines production with integrated upstream and downstream operations.
- Supports concurrent processing of multiple therapies, increasing capacity.
- Facilitates efficient factory-floor management with real-time performance data through the Illuminate™ platform.
- Applications
- Biopharmaceuticals,Gene therapy,Cell therapy,Advanced therapy medicinal products (atmp)
- End products
- Synthetic rna,Viral vectors,Crispr-edited genes,Monoclonal antibodies,Car-t cells,Stem cell therapies,Personalized vaccines,Lentiviral vectors,Regenerative medicine products,Genetically modified t-cells
- Steps before
- Material Introduction,Manual Decontamination,Decontamination Passages,Alternative Decontamination
- Steps after
- Product Packing,Filling,Quarantine,Sterilization
- Input ingredients
- sensitive starting materials,materials for decontamination,materials introduced through laminar flow hood
- Output ingredients
- manufactured Cell,Gene Therapy products,upgraded cleanliness materials,products processed in centrifuges,quarantine,and process incubators,products for integrated filling or packing options
- Market info
- Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.
- Modularity
- Advanced Modularity
- Flexibility
- Flexible in material introduction
- Processing Options
- Parallel processing
- Design
- Compact design
- Intelligence Platform
- Illuminate™ MI
- Stand-alone System Features
- Integrated freezer,Cooling system with integrated tube roller,Internal tray for transfer material,LAF hood for sensitive material inlet
- Decontamination Method
- Laminar Flow Hood for manual decontamination
- Decontamination Flexibility
- Alternative decontamination options
- Material Transfer
- Mousehole door for pressure maintenance
- Manufacturing Capacity
- Supports manufacturing for tens of patients concurrently
- Operation Capabilities
- All-in-one upstream,processing,downstream operations
- Customization
- Configurable combination of modules and accessories
- Modularity
- Advanced Modular Design
- Process Flexibility
- Parallel Processing
- Material Introduction
- Flexible Options
- Airflow System
- LAF Hood
- Decontamination Options
- Alternative to H₂O₂
- Flexibility in Decontamination
- Successive Passages for Grade A Cleanliness
- Internal Transfer Mechanism
- Mousehole Door
- Automation Level
- Integrated IIoT Platform
- Space Efficiency
- Compact Design
- Incubation Integration
- Quarantine and Process Incubators
- Stand-alone System
- All-in-one Upstream and Downstream Operations
- Manufacturing Efficiency
- Supports Multiple Patient Production Concurrently
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- ISO 9001
- Certified Quality System
- ISO 13485
- Certified Quality System
- ISO 45001
- Health and Safety Management System
- ISO 14001
- Environmental Management System
- ISO 50001
- Energetic Management System
- Machine footprint
- Modular design,stand-alone configuration
- Compact design
- Yes
- Module combination flexibility
- Yes
- Internal tray for transfer material
- Yes
- LAF (Laminar Air Flow) hood
- For sensitive material inlet
- Integrated freezer option
- Yes
- Cooling system with integrated tube roller
- Yes
- Mousehole door
- To maintain pressure cascade
- Processing chambers cleanroom grade
- Grade A
- Material introduction flexibility
- Yes
- Parallel processing capability
- Yes
- Compact design
- Yes
- Decontamination options
- Alternative to Hydrogen Peroxide
- Laminar Flow Hood
- Yes
- Mousehole door for pressure cascade
- Yes
- Stand-alone manufacturing options
- Yes
- Integrated equipment support
- Centrifuges,incubators
- Configuration variations
- Module combinations
- Illuminate™ Manufacturing Intelligence
- Data-driven improvements