Flexible, scalable, closed cell processing system for cell therapy manufacturing.

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Features


Comprehensive, closed cell processing system

The CTS Rotea Counterflow Centrifugation instrument, single-use kit, and software work together seamlessly to provide a closed cell processing system. The Rotea instrument is compact and versatile and integrates smoothly at multiple points in your workflow. The single-use kit includes all tubing and the rotating centrifuge chamber. Compatible with Luer connectors and sterile welding to the fluid containers, the gamma-irradiated kits help to ensure a closed system. Finally, the Rotea software runs on an adjacent tablet computer, allowing you to view and modify protocols and visually monitor the process in real time.

A complete closed cell processing system

Highly flexible instrument and software with sterile, single-use kit that scales with you from research through commercial manufacturing.

Gibco CTS Rotea Counterflow Centrifugation Instrument

Instrument

  • Compact
  • Multi-purpose
  • Easily integrates into your process
Gibco CTS Rotea Single-use kit

Single-use kit

  • Sterile closed kit
  • Flexible inputs and output ports
Screen showing Rotea software where you can view and modify protocols

Software

  • Intuitive user-programmable interface
  • Preset protocols available
  • Suitable for GMP manufacturing

“Rotea is exactly what the cell therapies sector has been waiting for: a flexible, single-use system that is aggressive on efficiency but gentle on cells.” Rebecca Lim,
Hudson Institute of Medical Research


Gentle counterflow centrifugation for viability, recovery, and small output volume

The CTS Rotea system separates cells using the principle of counterflow centrifugation (CFC), a versatile method for separating cells based on their sedimentation characteristics (size and density). The system suspends cells in a fluidized bed by exerting a constant flow force against centrifugal forces. The fluid-suspended cells are gently concentrated without ever forming a pellet in the cone and washed efficiently at unmatched recovery rates. Using elutriation, dead cells can be removed to optimize viability. Cell types of different sizes and densities can be separated with the Rotea system by tuning centrifugal speed and flow rate to create an imbalance of forces.

Diagram depicting cell loading step in counterflow centrifugation process

Cell loading

With “balanced” g-force and counterflow parameters, input material comprising media and cells is introduced to the CFC chamber via the central tube.

Diagram depicting elutriation step in counterflow centrifugation process

Elutriation

Larger/denser cells are captured in the fluidized bed, while smaller/less dense cells and debris pass through and are “eluted” through the top of the CFC chamber.

Diagram depicting media exchange/washing step in counterflow centrifugation process

Media exchange/washing

Wash buffer is pumped through the fluidized bed, replacing the original media in the input product. Note: The fluidized bed enables very fast and efficient washing.

Diagram depicting cell concentration step in counterflow centrifugation process

Cell concentration

Washed and concentrated cells are now recovered from the CFC chamber using proprietary Gibco Direct Draw Extraction Technology.

The CTS Rotea CFC process is powerful yet extremely gentle on cells compared to other separation methods. The fluidized bed supports low-shear processing, enabling over 95% cell recovery while maintaining cell viability and achieving high throughput. Research shows that cell morphology and viability of cells are similar before and after CFC, confirming that the process minimally perturbs cells.1

1Majore I, Moretti P, Hass R, Kasper C. Identification of subpopulations in mesenchymal stem cell-like cultures from human umbilical cord. Cell Commun Signal. 2009; 7: 6.


See counterflow centrifuge elutriation in action

The CTS Rotea system is designed to handle a wide range of input volumes from 50 mL to 20 L, and produce output volumes as low as 5 mL at concentrations up to 300 million cells/mL. These highly concentrated, low-volume cell outputs contain very little buffer or carryover, making them ideal for autologous cell therapy.


Exceptional process flexibility

The multipurpose CTS Rotea system is designed to fit within multiple stages of your existing processes and offers exceptional cell recovery and high throughput, making it easily serve a variety of processes including cell separation, concentration, washing, buffer exchange, and cryopreservation. This highly versatile system can process small-to-large input volumes (50 mL to 20 L) and output concentrations (5–300 x 106 cells/mL). All of the cell processing is contained within a closed, sterile single-use kit, whose fluid path is designed to be gentle on cells and allow easy recovery of cells from the processing chamber.

Create and optimize your own protocols

A user-friendly graphical user interface controls the CTS Rotea system. Choose from a menu of preset protocols or create and optimize your own protocol for cell separation, washing, and concentration. The on-board protocol builder guides you through the development process, and simulation software helps to ensure the protocols you create will perform as you intend before you try them on your samples. Additionally, the software is easily locked, so that when you’re ready to move your optimized process to manufacturing, users can no longer adjust the process settings.

Explore more about CTS Rotea software

Live view of your process

Live CellCam view of cells in the fluidized bed during counterflow centrifugation

The CTS Rotea system’s on-board CellCam (1-megapixel camera) lets you see cells live in the fluidized bed during counterflow centrifugation (CFC). This live visualization allows you to confirm that the programmed CFC parameters are accurately separating, concentrating, or elutriating the cells. If needed, users can then easily modify CFC parameters to create optimized protocols for multiple individual applications.

Utility at multiple stages of your process workflows

Example CAR-T workflow. The CTS Rotea CFC system is a highly versatile tool that is suitable for washing and concentration between multiple cell therapy processing steps. Common uses in a CAR-T workflow include isolating PBMCs from the apheresis product; isolating immune cells such as CAR-T and CAR-NK; isolating engineered cells such as CAR-T and CAR-NK; and cell wash and fill/finish.

Using counterflow centrifugation and elutriation of smaller cells, the CTS Rotea Counterflow Centrifugation System is designed to separate cells, aggregates, or beads based on size and is very gentle on fragile cells such as primary cells and iPSC aggregates. Labs using the Rotea system can take advantage of its utility at multiple stages of their existing process workflows.

Rotea system offers superior utility in these applications:

  • Cell wash/buffer exchange
  • Cell concentration
  • Elutriation/cell separation
  • Cell isolation and selection
  • Low-volume recovery
  • Small- to mid-scale cell processing
  • T cell and MSC wash and concentration
  • iPSC aggregate processing
  • PBMC/monocyte separation
  • RBC depletion
  • QC sample prep and isolation
  • Formulation for cryopreservation


Scalable from research to commercial manufacturing

Often, laboratory processes are not suitable for commercial manufacturing because they are not reproducible at that scale. Such processes can be difficult and costly to scale up or to transfer to a different commercial system.

The CTS Rotea Counterflow Centrifugation System can readily process a wide range of input and output volumes. That makes it useful not only for different tasks in the cell processing workflow, but also for different stages in the development and manufacturing process. You can use the system to develop and refine your processes, then later transition the processes seamlessly and confidently, locking protocols to meet clinical GMP manufacturing requirements and dramatically reducing the costs of transitioning to another system.2 Alternatively, you can use CTS Rotea instruments for key processes to supplement, streamline, and even improve existing manufacturing workflows in fully integrated cell therapy processing systems.

CTS Rotea systems offer the flexibility to explore, experiment, and refine your processes and protocols during R&D. When you’re ready to manufacture, lock down the settings to maximize reproducibility every time.

Because the system is modular, you can separate rapid process steps such as cell separation, washing, and concentration from lengthy process steps such as cell expansion. As you scale up, simply add as many CTS Rotea instruments as you need for each step to keep up with the workflow. If needed, you can transition from standard single-use kits (flow rates 5–110 mL/min) to high-flow kits (30–160 mL/min), while all processes remain exactly the same.

The modular, closed process minimizes the need for biosafety cabinets and large, costly class A and B clean rooms. With single-use kits, you can simultaneously process multiple batches in a shared grade C clean room. Only the more hazardous processes need to be contained and mitigated.

Download our article on cell therapy scale-up

2James D. How short-term gain can lead to long-term pain. Cell Gene Therapy Insights. 2017; 3: 271-284.


Regulatory documentation and support

Choosing a system that meets regulatory requirements is critical for the long-term success of your therapeutic development and has significant implications for clinical translation and manufacturability. Investing in the development of a closed, scalable automated system prior to regulatory approval can reduce risk and potential time lost to changing systems as you progress from research to commercialization. A Gibco CTS Rotea system can streamline and expedite your cell therapy development.

CTS reagents are backed by testing and regulatory support

Cell therapy systems (CTS) products are designed to enable GMP clinical and commercial cell and gene therapy manufacturing. They are backed by testing and regulatory support to help reduce risk and enable you to confidently move from research to clinical and commercial cell therapy development.

See the quality, testing and support behind our Gibco CTS reagents

Designed to meet cell therapy regulatory requirements

Regulatory Support Files (RSF) are available upon request and include:

  • For the instrument
    • Instrument safety compliance standards
  • For single-use kits
    • Materials of Construction
    • Biocompatibility
    • Extractable and sterility assurance summary data
    • Detailed lot-specific Certificate of Analysis

CTS Rotea Counterflow Centrifuge and CTS Rotea Single-Use Kit are manufactured under ISO13485, adhering to all compliance guidelines.

Rotea graphical user interface software has multiple user privileges, including locked manufacturing operator mode.

OPC-UA interface, industry-standard machine communication language, enables connection to a MES/LIM or 21 CFR Part 11 compliant system.

Contact us for more information on meeting regulatory requirements