Comprehensive, closed cell processing system

The CTS Rotea Counterflow Centrifugation instrument, single-use kit, and CTS Rotea software work together seamlessly to provide a closed cell processing system. The CTS 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 CTS Rotea software runs on an adjacent computer, allowing you to view and modify protocols and visually monitor the process in real time. 

Awards & Recognition

The Gibco CTS Rotea Counterflow Centrifugation System has been recognized as a 2021 - 2022 Winner of the following industry awards:

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.

Instrument

  • Compact
  • Multi-purpose
  • Easily integrates into your process

Single use kit

  • Sterile closed kit
  • Flexible inputs and outputs ports

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

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 high recovery rates. Using elutriation, dead cells can be removed to optimize viability. Cell types of different sizes and densities can be separated with the CTS Rotea system by tuning centrifugal speed and flow rate to create an imbalance of forces.

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.

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.

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.

Cell concentration

Washed and concentrated cells are now recovered from the CFC chamber by simply reversing the pump and extracting the concentrate via the internal tube.

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

¹ Majore 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. Full text

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.

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 Rotea Protocol Builder software guides Rotea users 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.

Live view of your process

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 T and NK cells; isolating engineered cells such as CAR-T and CAR-NK; and cell wash.

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 CTS Rotea system can take advantage of its utility at multiple stages of their existing process workflows.

The CTS Rotea system offers superior utility in these applications:

Cell wash/buffer exchange T cell and MSC wash and concentration
Cell concentration iPSC aggregate processing
Elutriation/cell separation PBMC/monocyte separation
Cell isolation and selection Dead cell removal and depletion
Low-volume recovery QC sample prep and isolation
Small- to mid-scale cell processing Customer controlled protocol development

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 can reduce the costs of transitioning to another system.² Alternatively, you can use CTS Rotea instruments for key processes to supplement, streamline, and help improve existing manufacturing workflows in fully integrated cell therapy processing systems.

CTS Rotea systems flexibility 

 

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.

 

² James 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.

 

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

Software to help enable 21 CFR part 11 compliance

When scaling up to commercial manufacturing, we recommend purchasing one of the two software options available, the CTS Rotea SAE Software or the Gibco CTS Cellmation Software for DeltaV Systems to help enable 21 CFR part 11 compliance. Both software options help customers prepare for audit and regulatory filing processes. Customers maintain the final responsibility for 21 CFR Part 11 compliance. 

 

The Rotea SAE Software is designed for customers who want to upgrade a single, standalone instrument. The capabilities include password policies, user role designations, role permissions, tracking of actions and information via an audit log, and electronic signature configuration for specific functions. Customer preferences for these SAE settings are managed within the SAE Administrator Console, which is recommended to be installed on the co-located computer to ensure uninterrupted communication between the system and the software for continuous tracking.

 

 

Functionality of the SAE Administrator Console

Function Description
System security Controls user access to the software through user IDs, passwords, roles, and permissions. Three default user roles are provided, one with full privileges (Administrator), one with some privileges removed (Lead scientist) and the other with no privileges (Technologist). Default user roles can be edited, and additional user roles and permissions can be created.
Auditing Tracks actions performed by users, and changes to the SAE Admin Console settings. The software automatically audits some actions silently. You can select other items for auditing and specify the audit mode. The auditing function provides reports for audited SAE Admin Console changes and actions.
Electronic signature (e-signature) Determines the functions for which users are required to provide a username and password. You can configure e-signatures so that a user can export a signed file and print a signed report. You can also configure the e-signature to require multiple signatures and to require users with specific permissions to sign.

 

The Gibco CTS Cellmation Software for the DeltaV System is for customers who want to enable 21 CFR part 11 compliance across multiple CTS Systems with the help of a DeltaV distributed control system (DCS).

 

 

Ordering information for available software upgrades

The Rotea SAE Software or the Cellmation Software for DeltaV Systems can be purchased as part of an initial instrument purchase or as a separate, standalone purchase. Both software options require a system upgrade service by a member of the Global Service and Support team to enable the software.

For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. Caution: Not intended for direct administration into humans or animals.