Cell Therapy Solutions
CTS™ Xenon™ Electroporation System
The Gibco™ CTS™ Xenon™ Electroporation System is a closed, modular, large-scale platform that offers full control over electroporation parameters for optimal performance. The system delivers exceptional transfection performance and viability, enabling electroporation of up to 2.5 billion cells in a 25 mL run to support both process development and manufacturing work in clinical cell therapy. Utilizing a user-programmable interface, it provides the flexibility needed to optimize protocols for a variety of cell types and payloads, ensuring high-quality results from research through commercialization.
High-Performance, Scalable Non-Viral Delivery for Clinical Manufacturing
The CTS Xenon System is specifically engineered to meet the rigorous demands of CAR T cell therapy and other advanced immunotherapies. By providing a closed and automated non-viral delivery workflow, it addresses critical challenges in cell therapy manufacturing, ensuring high-quality gene modification for both autologous and allogeneic cell-based products. The system allows for efficient delivery of various payloads, including DNA, RNA, and proteins, while providing the robustness needed for reliable therapeutic production.
Exceptional Transfection Performance and Viability
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High Efficiency: Achieve up to 90% gene knockout and up to 80% cell viability when used with Gibco CTS TrueCut Cas9 Protein.
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Proven Performance: Benchmarked against the Invitrogen Neon Transfection System, the CTS Xenon system enables seamless translation to large-scale processing without a drop in performance.
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Rapid Processing: Capable of transfecting up to 2.5 billion T cells in a 25 mL volume in less than 25 minutes.
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Precision Control: Delivers consistent results through an embedded graphical user interface (GUI) that allows for full optimization of electroporation protocols.
Integrated Fluidics and Parameter Management
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Automated Processing: Features intuitive software to manage all instrument actions, including voltage, pulse width, and pulse number.
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Full Control: Users can customize parameters such as voltage (500–2,500 V), pulse width (1–30 ms), and number of pulses (1–10) to suit specific cell types.
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Precooling Technology: Integrated Peltier technology for precooling (10–30°C) ensures optimal temperature control during the electroporation process.
Versatile Scalability and Optimized Consumables
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Scalable Consumables: Offers the CTS Xenon SingleShot chamber for rapid 1 mL process development and the CTS Xenon MultiShot cartridge for consistent, closed-system manufacturing volumes up to 25 mL.
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Flexible Buffers: Compatible with specialized buffers, including CTS Xenon Genome Editing Buffer and Lower Conductivity Buffer, designed specifically for high-energy electroporation needs.
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Seamless Translation: Facilitates a direct path from discovery to clinical manufacturing, allowing for process refinement at small scale before transitioning to large-scale production.
GMP-Compliant Manufacturing and Connectivity
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Sterile Environment: Closed, single-use MultiShot cartridges enable sterile processing within Class C cleanroom facilities.
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Regulatory Compliance: Manufactured in ISO 13485-certified facilities with software options designed to help enable 21 CFR Part 11 compliance.
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Digital Integration: Features an OPC UA interface for seamless communication with MES/LIMS platforms and DeltaV systems via CTS Cellmation Software.
CTS™ DynaCellect™ Magnetic Separation System
The Gibco™ CTS™ DynaCellect™ Magnetic Separation System is an automated instrument for T-cell isolation and activation, as well as magnetic bead removal. The instrument utilizes an integrated magnet-rocker and fluidics management for target-cell separation and subsequent bead removal in a closed system. The key design feature is the user-programmable software, which enables design flexibility, performance precision, and scalability from process development to commercial manufacturing. Together with the fit-for-purpose, sterile, single-use consumables, it delivers high cell purity, recovery, and viability.
Advanced Solutions for CAR T and Cell Therapy Manufacturing
The CTS DynaCellect System is specifically engineered to meet the rigorous demands of CAR T cell therapy and other advanced immunotherapies. By providing a closed and automated workflow, it addresses critical challenges in cell therapy manufacturing, ensuring high-quality starting material for gene modification and expansion. Whether you are working on autologous or allogeneic cell-based products, the system provides the robustness needed for reliable therapeutic production.
Isolation Efficiency, Purity, and Viability
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Exceptional Performance: Enables >88% isolation efficiency of target cells with 97% purity when used with CTS™ Detachable Dynabeads™ CD3/CD28.
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Cell Integrity: The magnetic separation process maintains cell viability and phenotype throughout the workflow.
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Precision: Delivers highly reproducible results with a coefficient of variation (CV) of 3%.
Integrated Fluidics and Magnetics Management
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Automated Processing: Features intuitive software to manage all instrument actions, including magnet engagement, pinch valve control, and pump speeds.
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Rocker Mechanism: Integrated rocker with adjustable angles (-30° to 30°) and speeds (1–30 cpm) for optimal cell and bead interaction.
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Flow Control: Precise fluidics management with pump speeds ranging from 1 to 150 mL/min.
Versatile Scalability and Speed
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Scalable Volumes: Supports a flexible reaction volume from 10 mL up to a 1,000 mL maximum working volume, equivalent to approximately 10 billion T cells as input for cell isolation.
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Rapid Isolation: Typical processing time for isolation is between 70 and 100 minutes.
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High-Volume Bead Removal: Verified bead removal for volumes up to 10 L using a continuous flow process.
GMP-Compliant Manufacturing and Connectivity
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Sterile Environment: Closed, single-use kits enable processing within Class C cleanroom facilities.
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Regulatory Compliance: Manufactured under ISO 13485 standards with an optional software module for 21 CFR Part 11 compliance.
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Digital Integration: Features an OPC-UA interface for seamless communication with DeltaV™ systems and MES/LIMS platforms.
CTS™ Rotea™ Counterflow Centrifugation System
The Gibco™ CTS™ Rotea™ Counterflow Centrifugation System is an award-winning, highly versatile tool designed for cell separation, concentration, washing, and buffer exchange. Utilizing innovative Counterflow Centrifugation (CFC) technology, the system suspends cells in a fluidized bed by exerting a constant flow force opposing centrifugal forces. This unique mechanism provides capabilities beyond traditional centrifuges, delivering high cell recovery and viability in a closed, automated environment from process development through commercialization.
Versatile Applications in Cell and Gene Therapy
The CTS Rotea System is engineered to support a broad range of functionalities across the cell therapy workflow:
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Advanced Cell Processing: Optimized for T cell, NK cell, and MSC wash and concentration.
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Specialized Harvesting: Enables MSC harvesting from Cell Factory Systems and iPSC aggregate processing.
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Viral Vector Manufacturing: Suitable for Lentiviral vector clarification and residual wash out applications.
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Precision Separations: Facilitates PBMC/monocyte separation, RBC depletion, and elutriation.
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Quality & Research: Ideal for QC sample prep, isolation, and small- to mid-scale cell processing.
High Efficiency and Integrated Technology
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Superior Recovery and Viability: Gentle processing enables >95% cell recovery while maintaining high cell viability.
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Low-Volume Output: Proprietary DirectDraw extraction technology can deliver as little as 5 mL of concentrate, providing highly concentrated cell populations.
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Live Visualization: Integrated Gibco™ CellCam™ video technology allows users to visualize cells live in the fluidized bed for precise parameter optimization.
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Customer-Controlled Development: User-friendly software enables the creation, modification, and assessment of custom protocols to suit unique applications.
Scalability and Speed
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Flexible Input Range: Supports a wide recommended input volume range from 50 mL up to 20 L.
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Rapid Processing: Capable of washing and concentrating 1 L of cells in approximately 18 minutes or isolating PBMCs from a full leukopak bag in about 85 minutes.
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Modular Integration: Designed for easy integration into existing workflows, allowing for a seamless transition from research to GMP manufacturing.
GMP-Compliant Manufacturing and Connectivity
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Sterile, Closed System: Single-use kits enable sterile processing in Class C cleanroom facilities, reducing the requirement for high-grade lab space by up to 90%.
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Regulatory Support: Manufactured in an ISO 13485-certified facility with software options designed to help enable 21 CFR Part 11 compliance.
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Digital Connectivity: Features an OPC-UA interface for connection to MES/LIMS platforms and available CTS™ Cellmation™ Software for integration with DeltaV™ systems.
CTS™ Compleo™ Fill and Finish System
Automated, flexible formulation and fill system designed for cell therapy manufacturing
The Gibco™ CTS™ Compleo™ Fill and Finish System is a functionally closed, automated system that reduces variability to help better control formulation and filling as compared to manual processing. It enables solutions to help overcome common challenges that arise during the manual workflow, streamlining the process from process development to commercial manufacturing.
Key Features and Benefits
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Functionally Closed Automation: Reduces formulation and fill process variability while maintaining aseptic integrity through closed-system processing.
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Intelligent Formulation Software: A proprietary algorithm automates complex calculations, reducing manual errors and optimizing cell usage to minimize unnecessary cell waste.
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High Dosing Accuracy: Delivers a volumetric accuracy of ±10% even at ultra-low fill volumes as small as 0.5 mL.
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Modular Integration: Designed to work in harmony with the CTS™ Rotea™ system, allowing the output bag to be placed directly onto the Compleo™ system.
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System-Agnostic Flexibility: Can be implemented with other cell processing platforms to enhance formulation and filling efficiency across diverse workflows.
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Operational Speed: Automates air removal and processing, reducing formulation and filling time from an average of 45 minutes to approximately 15 minutes.
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GMP-Ready Compliance: Supports 21 CFR Part 11 compliance via an optional SAE software solution and an OPC-UA interface for seamless integration with DCS/MES systems.
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Real-Time Flexibility: The user-friendly Protocol Builder software handles variable batch sizes in real time without requiring manual protocol modification or requalification.
Technical Specifications
Input Capacity: Up to 4 inputs depending on in-process sample allocation Input Volume: 10 mL (minimum), 750 mL (maximum) Flow Rate: 5–50 mL/min Number of Outputs: 1–10 depending on number of input bags and orientation Output Volume Range: 0.5 mL to 750 mL per individual dose Output Volume Accuracy: ±10% across the full range (0.5 mL to 750 mL) Volume Verification: Independent volume checking mechanism; bubble sensors measure the volume transferred based on the volume of fluid pumped Output Container Compatibility: Compatible with most cryobags and vials; supports connection via luer lock fittings or direct sterile weld to the bag inlet line In-process Sampling: Can dispense multiple samples with as little as 0.2 mL per sample Air Removal (Burping): Automatic (pre- and/or post-fill) and manual Connectivity: OPC-UA interface Operating Noise Level: 65 dBA (typical) to 70 dBA (maximum) Dimensions (H x W x D): 31.5 x 11.4 x 18.0 in (80 x 29 x 46 cm) Weight: 55.0 lb (25.0 kg)
Cell Therapy Solutions
Discover Thermo Fisher Scientific integrated cell therapy solutions to support your development efforts at every stage. Through high-quality tools and services, our goal is to enable you from initial discovery through clinical trials to commercially viable cell therapies.
Cell Therapy Systems (CTS): from high-quality cGMP manufactured cell therapy ancillary materials to regulatory documentation and safety testing, find out how our CTS products can connect your clinical stem cell therapy and immunotherapy research to the clinic, and beyond.
• CTS Media and Supplement GMP manufactured designed for cell and gene therapy to support your transition from discovery through clinical and commercial manufacturing.
• Cell Therapy Instruments, supporting consumables and software products enable CGMP compliant, closed system manufacturing and allow for physical and digital integration.
• Viral vector systems cost-effective, scalable solutions designed to transition your gene therapy workflow from discovery to commercial manufacturing.
Download Cell Therapy Brochure and connect with the solutions and guidance you need to advance your cell therapies.
PeproGMP Recombinant Proteins
Recombinant proteins are often among the key raw materials used in clinical manufacturing of biotherapeutics, so strong supply chain continuity and scaling capabilities are important considerations when choosing a GMP cytokine or other GMP protein supplier.
Thermo Fisher Scientific offers GMP proteins that can help you seamlessly scale your cell production process while meeting all clinical requirements. Gibco PeproGMP cytokines are designed and manufactured to support end-to-end manufacturing of cell therapies and other biotherapeutics.
All PeproTech GMP proteins are manufactured in E. coli using defined media, enzymes, and chemicals that are animal- and human-origin free. GMP recombinant proteins are available for a wide range of applications, including culture and modification of stem cells, immune cells, and organoids.
PeproTech GMP recombinant proteins are manufactured for use as ancillary materials by applying applicable principles of GMP and quality control requirements from USP (United States Pharmacopeia) Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products.
PeproGMP cytokines are developed and manufactured with quality, scale, and regulatory compliance in mind. Thermo Fisher Scientific has a dedicated 65,000 square foot facility for recombinant protein development and manufacture. All PeproTech recombinant proteins are now manufactured at this facility for high quality and consistency.
PeproTech proteins manufacturing facility features:
- Controlled and certified ISO Class 7 and Class 8 cleanrooms for GMP manufacturing
- Dedicated animal-free labs
- Centralized manufacturing to ensure lot-to-lot consistency
Download the PeproGMP brochure to view the full list of products.
Dynabeads Magnetic Beads
Dynabeads products center around the goals to provide reliable and reproducible results for the purification and analysis of cells, proteins, exosomes, DNA, RNA, and other molecules. Dynabeads magnetic beads and products deliver highly cited results in the research industry across multiple application areas. Meanwhile, Thermo Fisher Scientific provides exceptional service and support backed by over 30+ years of knowledge and expertise.
What are Dynabeads magnetic beads?
- Dynabeads magnetic beads are superparamagnetic particles—they exhibit magnetic properties when placed in a magnetic field but retain no residual magnetism once removed from the magnetic field
- Unique batch-to-batch reproducibility secures reproducible, quality results
- Spherical shape and defined surface chemistry minimizes chemical agglutination and non-specific binding
- Polymer shell on each bead protects your target from toxic exposure to iron
- Bioreactive molecules can be absorbed or coupled to their surface, and used to separate biological materials (cells, proteins, nucleic acids, etc.)
Dynabeads magnetic beads come in several sizes and different surface functionalities for use in a wide variety of applications. Some beads are precoupled with a biomolecule (ligand). The ligand can be an antibody, protein or antigen, DNA/RNA probe, or any other molecule with an affinity for the desired target.
Gibco LV-MAX Lentiviral Production System
Lentiviral vector production suspension solutions, for research and therapy:
The Gibco LV-MAX Lentiviral Production system is the first optimized system that provides all the high-quality components you need in a chemically defined, serum-free environment.
- High titers—greater than 1 x 108 TU/mL (unconcentrated)
- Research-grade and CTS options—seamlessly transition from discovery to commercial production
Optimized and fully integrated system includes:
HEK 293–derived suspension cells, serum-free media, proprietary transfection reagent, supplement, and our novel enhancer. Gibco HEK 293 derived viral production cells have been optimized for viral production in suspension culture.
