The CTS Rotea Counterflow Centrifugation System offers a variety of features, all of which work together to provide a closed system able to integrate smoothly at multiple points in cell therapy processing workflows. The gentleness of counterflow centrifugation using the Rotea system helps to ensure high levels of cell recovery and viability. The single-use kits provide sterile tubing with flexible ports for input and output of media and reagents, and the intuitive software runs on an adjacent computer, allowing protocols to be viewed and modified while visually monitoring processes in real time.
Functionalities and capabilities of the CTS Rotea Counterflow Centrifugation System | |
Low-volume recovery | Customer-controlled protocol development |
Small- to mid-scale cell processing | T cell, NK cell, and MSC wash and concentration |
Cell wash/buffer exchange | iPSC aggregate processing |
Cell concentration | PBMC/monocyte separation |
Elutriation and cell separation | RBC depletion |
Residual wash out | QC sample prep and isolation |
MSC harvesting from Cell Factory Systems | Lentiviral vector clarification |
Counterflow centrifugation (CFC) is an effective method for gently separating cells based on their sedimentation characteristics (size and density). The Rotea Counterflow Centrifugation 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. By tuning centrifugal speed and flow rate to create an imbalance of forces, cell types of different sizes and densities can be separated.
The CTS Rotea counterflow centrifugation process is efficient 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 counterflow centrifugation, confirming that the process minimally perturbs cells.¹
Watch to learn more about how the Rotea system and gentle counterflow centrifugal elutriation can help revolutionize cell therapy workflows.
The automated, multi-purpose CTS Rotea system is designed to fit within multiple stages of existing workflows and offers high throughput and exceptional cell recovery. These features allow the Rotea system to easily serve a variety of processes including cell separation, concentration, washing, and buffer exchange. This versatile system can process small-to-large input volumes (50 mL to 20 L) and output concentrations (5 to 500 x 10⁶ cells/mL). All cell processing is contained within a closed, sterile single-use kit, which is designed to be gentle on cells and allow for easy recovery of cells from the CFC chamber.
The CTS Rotea system’s onboard CellCam (1-megapixel camera) allows cells to be viewed live in the fluidized bed during counterflow centrifugation (CFC). This live visualization allows for confirmation 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 various applications.
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 500 million cells/mL. These highly concentrated, low-volume cell outputs contain very little buffer or carryover, making them excellent for autologous cell therapy.
Due to the modularity of the system, rapid process steps such as cell separation, wash, and concentration can be decoupled from lengthy process steps like cell expansion. When scaling up, simply add as many CTS Rotea instruments as needed for each step in the workflow, reusing a single piece of equipment for multiple workflow operations. Although it can be used with biosafety cabinets and large, costly class A and B rooms, the modular, closed process minimizes the need for them. With the closed operation of the Rotea system, simultaneously process multiple batches in a shared grade C clean room using the single-use kits.
Often, laboratory processes are not suitable for commercial manufacturing because they are not reproducible at large 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, making it useful not only for different tasks in the cell processing workflow but also for different stages in the development and manufacturing process. Use the system to develop, refine and automate processes, then later transition those processes seamlessly and confidently with Thermo Fisher Scientific’s software for enabling 21 CFR Part 11 compliance (Rotea SAE software or Cellmation software) to support GMP manufacturing requirements. This smooth transition also reduces the costs of moving to another system.2
Additionally, use CTS Rotea instruments for key processes to supplement, streamline, and help improve existing manufacturing workflows in fully integrated cell therapy processing systems.
² James D. How short-term gain can lead to long-term pain. Cell Gene Therapy Insights. 2017; 3: 271–284.
Choosing a system that meets regulatory requirements is critical for the long-term success of 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 manual systems during the progression from process development to commercialization. A Gibco CTS Rotea system supports efficient and effective cell therapy by reducing human error and allowing scientists to spend their time on critical thinking steps while the system provides reliable and reproducible results that do not sacrifice the quality of manual processing.
Cell therapy systems (CTS) products are designed to enable GMP cell and gene therapy manufacturing. They are backed by testing and regulatory support to support customers from discovery to clinical and commercial cell therapy development.
Regulatory Support Files (RSF) are available upon request and include:
For the instrument | For single-use kits |
---|---|
Instrument safety compliance standards | Materials of Construction |
Validation testing summary | Biocompatibility |
Extractable data | |
Sterilization and sterility data | |
Accelerated and real-time stability data |
CTS Rotea Counterflow Centrifuge and CTS Rotea Single-Use Kits are manufactured in an ISO 13485 facility adhering to all compliance guidelines.
Rotea graphical user interface software has multiple user privileges, including enhanced security, auditing, and e-signature functionality through the Rotea SAE software upgrade.
OPC-UA interface, an industry-standard machine communication language, enables connection to a MES/LIM or 21 CFR Part 11 compliant system.
The CTS Cellmation Software is powered by the DeltaV™ DCS from Emerson and has been developed following GAMP5 methods to help ensure compatibility with cGMP-compliant processes.
Catalog number | Description | Item Count | Price |
---|---|---|---|
A50760* A47679** |
CTS Rotea System + 2-year service | 1 each |
Get a quote |
A50757* A47695** |
CTS Rotea System + 2-year service (including OQ after PM) + IQOQ | 1 each | Get a quote |
* North America, Europe
** Rest of World
For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products.