Cell & gene therapy isolator with integrated incubation
Enhance your cell and gene therapy workflow with a modular isolator that seamlessly integrates incubation and decontamination, streamlining high-throughput processes and ensuring a certified aseptic environment.
Facilitates Isolation, Incubation, and Decontamination Processes
The ValueCell FLEXY from Comecer is a modular cell and gene therapy isolator designed to address the specific needs of pharmaceutical manufacturers and biotech companies involved in regenerative medicine and advanced therapy medicinal products. This isolator excels by integrating seamlessly with operational workflows, offering features like fully PLC-controlled operations and GAMP 5 software compliance, enhancing both automation and data integrity. Utilizing vapor phase hydrogen peroxide, it ensures robust decontamination, maintaining sterile environments critical for culturing CAR T-cells, iPSC-derived cardiomyocytes, and more. Its modular design allows it to link with FlexyCult™, optimizing incubation capacity and overcoming bottlenecks. The isolator includes integrated centrifugation, freezing, and sampling solutions within its high-grade stainless steel chambers, guaranteeing durability and compliance with GMP standards. Customizable features and engineering support further enable specific process optimizations, making it an indispensable asset for high-throughput and batch operations in advanced therapy labs.
Benefits
- Enhances production capacity by resolving incubation bottlenecks and optimizing workflow integration.
- Maintains sterile conditions with efficient vapor phase hydrogen peroxide decontamination, ensuring product integrity.
- Reduces labor costs and operational errors through full PLC automation and user-friendly HMI interface.
- Supports scalable operations with customizable modular design tailored for cell and gene therapy needs.
- Complies with stringent GMP standards, ensuring regulatory alignment in pharmaceutical and biotech applications.
- Applications
- Cell,Regenerative medicine,Gene therapy,Tissue engineering,Advanced therapy medicinal products (atmp)
- End products
- Personalized cancer vaccines,Bioprinted organs,Ipsc-derived cardiomyocytes,Car t-cells,Engineered tissue scaffolds,Gene-edited t cells,Tcr-t cells,Mesenchymal stem cells,Genetically modified hematopoietic stem cells,Exosome-based therapeutics
- Steps before
- Material Preparation,Incubation,Cell Culturing
- Steps after
- Decontamination,Quality Control,Data Analysis
- Input ingredients
- cell cultures,laboratory materials,production materials
- Output ingredients
- processed cell therapies,analyzed culture samples,decontaminated materials
- 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.
- Laminar airflow
- High Efficiency
- Control System
- Fully PLC controlled
- Software Compliance
- GAMP 5 compliant,21CFR Part 11 available upon request
- Decontamination System
- Vapor Phase Hydrogen Peroxide
- Material Internal
- High grade stainless steel AISI 316L
- Material External
- AISI 304
- Chamber Construction
- Fully welded with 20 mm radius
- Manufacturing Intelligence Platform
- Illuminate™ MI
- Pressure System
- Positive pressure chambers
- RTP Connections
- Sealed RTP for FlexyCult™ integration
- Sampling Ports
- Single use sampling ports
- Incubation System Integration
- Supports FlexyCult™
- Automation level
- PLC-controlled
- Airflow
- Laminar Airflow
- Decontamination method
- Vapor Phase Hydrogen Peroxide (VPHP)
- Isolation environment
- Grade A aseptic conditions
- Chamber pressure
- Positive pressure
- Integration capability
- Flexycult incubation system
- Process configuration
- Modular
- Customizable integrated cells incubator
- Integrated instruments
- Centrifuge,freezer,peristaltic pump,refrigerator
- Parallel processing
- Multiple processes in parallel sessions
- Abrasion resistance
- Yes
- Biological compatibility
- Yes
- Cleanability
- High grade stainless steel (AISI 316L)
- Corrosive resistance (e.g. acids)
- Highly resistant
- Density/particle size
- Compatible with various densities and sizes
- 21 CFR Part 11
- Available upon request
- Material
- High grade stainless steel AISI 316L internally and AISI 304 externally
- Design
- Fully welded chamber with 20 mm radius
- Isolator Chambers
- 3 chambers with positive pressure
- Footprint
- Modular and compact for space saving
- Connectivity
- Sealed RTP connections with FlexyCult
- Interface Type
- Friendly operator interface (HMI)
- Control panel type
- PLC-controlled,HMI
- Integration Possibilities
- Flexycult integration
- Modular Design
- Yes,various module combinations
- Interface Connectivity
- RTP with FlexyCult™
- Decontamination System
- Vapor Phase Hydrogen Peroxide (VPHP)
- Material Construction
- Stainless Steel AISI 316L / AISI 304
- Manufacturing Intelligence System
- Illuminate™ MI Platform
- Integrated Equipment
- Centrifuge,Freezer,Peristaltic Pump,Refrigerator