Solutions for manufacturing cell therapy products must be designed for safety, process flexibility, and scale-up from research through commercial manufacturing. A counterflow centrifugation system designed for closed manufacturing reduces the risk of errors associated with manual cell processing to create a safer product. A system designed for process flexibility allows users to optimize protocols for cell separation, washing, and concentration, and closed single-use kits enable sterile processing to facilitate scale-up to manufacturing.
This resource guide outlines:
- The key benefits the versatile Gibco™ CTS™ Cell Therapy Systems (CTS™) Rotea™ Counterflow Centrifugation System
- How the combination of instrument, kits, and software scales from research through commercial manufacturing
- Performance data (including viability after T cell washing and concentration and high recovery from Leukopak bag)
Download this resource guide to learn how a closed cell-processing system for cell therapy manufacturing can seamlessly scale with your process from research through commercial manufacturing.
The CTS Rotea Counterflow Centrifugation System
Close your system, free your process
The CTS Rotea system—a closed cell-processing system for cell therapy manufacturing
The multipurpose Gibco™ Cell Therapy Systems (CTS™) Rotea™ Counterflow Centrifugation System offers unparalleled flexibility. This highly versatile system features user?programmable software to enable a broad range of cell processing applications.
The CTS Rotea system offers exceptional cell recovery, flexible input and output volume capability, and high throughput, making it ideal for cell separation, concentration, washing, and more. The compact footprint, process flexibility, and closed single?use kit allow the system to seamlessly scale with your process, from research through commercial manufacturing.
Key benefits
Process flexibility—user-programmable software enables you to create and optimize a broad range of protocols for cell separation, washing, and concentration
High cell recovery and viability—gentle processing enables >95% cell recovery while maintaining cell viability
Low output volumes—proprietary technology can deliver as little as 5 mL of concentrate
Research through commercial manufacturing—the closed single-use kit enables sterile processing, and an Open Platform Communications Unified Architecture (OPC-UA) interface enables connectivity to a 21 CFR Part 11–compliant system
Highly flexible system that scales with you from research through commercial manufacturing
Instrument
Compact
Multipurpose
Easily integrates into your process
Single-use kit
Sterile
Closed
Flexible input and output ports
Software
User-programmable
Preset protocols available
Suitable for GMP manufacturing
A versatile instrument with many possibilities for use throughout your workflow
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
RBC depletion
Low-volume recovery
QC sample prep and isolation
Small- to mid-scale cell processing
Formulation for cryopreservation
Cell therapy processing
The CTS Rotea Counterflow Centrifugation System is a highly versatile tool that is suitable for cell separation, as well as buffer exchange and cell concentration between cell therapy processing steps.What the CTS Rotea system does at each step
FEATURES
Instrument
Counterflow centrifugation (CFC)—improves your entire cell therapy workflow from research to
manufacturing by using powerful, scalable technology. The system suspends cells in a fluidized bed by exerting a constant flow force opposite centrifugal forces to provide capabilities impossible for traditional centrifuges. Fluid-suspended cells are gently concentrated without ever forming a pellet in the cone and washed quickly and efficiently at unmatched recovery rates. Due to their reduced cell density, dead cells can be removed to optimize viability before delivery. Cell types of different sizes can be separated by tuning centrifugal speed and flow rate to create an imbalance of forces.
Gibco™ CellCam™ video technology—visualizes cells live in a fluidized bed through color camera, enabling CFC parameter optimization. This allows users to easily fine-tune protocols for each application.
Gibco™ DirectDraw™ extraction technology—allows extremely low-volume output at up to 300M cells/mL.
Process monitoring—prevents and detects faults.
Compact footprint—fits on a benchtop.
Processing times and instrument specifications
Processing Times and Instrument Specifications 
Specifications
Instrument
Centrifugal force
3,000 x g
Peristaltic pump flow rate
5–110 mL/min (Standard Kit) 30–160 mL/min (Hi-Flow Kit)
Centrifuge chamber volume
10 mL
Cell count per chamber load
5 x 10?–5 x 10? cells*
Output cell concentration
5 x 10?–500 x 10? cells/mL
Recommended input volume range
50 mL–20 L
Minimum output volume
5 mL
Maximum fluid density
1.10 g/mL
Operating noise level
<70 dBA
Dimensions (H x W x D)
16 x 11.4 x 20 in. (body only), 30 x 11.4 x 20 in. (with bag poles)
40 x 29 x 50.8 cm (body only), 76.2 x 29 x 50.8 cm (with bag poles)
Weight
44 lb (20 kg)
Tablet accessory model
2-in-1 Dell™ system (laptop and tablet)
* Dependent upon cell type. Centrifuge can be filled multiple times to process larger batches.
Note: Instrument and Consumable Regulatory Support File available upon request at thermofisher.com/regulatory
Consumable kits
Single-use kit is simple to use, provides flexibility for process development, and can be customized to support commercial-scale manufacturing
Enable multiple batches to be processed in a shared, Class C–clean room leading to cost-effective transfer and scale-out
Compatible with Luer connectors and sterile welding
The CTS Rotea Counterflow Centrifugation System is a highly versatile tool that is suitable for cell separation, as well as buffer exchange and cell concentration between cell therapy processing steps.
Gamma sterilized
Tube material: DEHP-free PVC
Standard kit: flow rates of 5–110 mL/min
Hi-Flow kit: flow rates of 30–160 mL/min
Intuitive software
CTS Rotea system software interface
User-friendly graphical user interface (GUI) is capable of fine-tuning protocol parameters for each application
This OPC-UA allows connectivity to 21 CFR Part 11–compliant system or MES/LIS software
Easily switches between R&D and manufacturing operator modes
CTS Rotea system software and firmware updates are customer-installable through the GUI
Capability to connect to the Thermo Fisher Scientific cloud platform
Protocol Builder
Create/modify/save/upload protocols
A field application scientist from our global service and support team will guide you through each step to create a protocol that fits your application
Customizable settings provide flexibility to suit each unique application
Simulation software
Simulates a protocol in the absence of physical system; allows the user to troubleshoot a protocol
Helps user determine what bag volumes and run times are required to complete a specific protocol
Facilitates protocol functionality assessment prior to running the protocol on instrument
Process model
Advanced fluid dynamics model helps users determine, based on their cells and media/buffer, which counterflow centrifuge and pump parameters to start with
Commonly used reagents, buffer, and media are pre- installed in the model
10
% of cells
% of cells recovered
A library of cell types is pre-installed in the model, including: RBCs, lymphocytes, lymphocytes (small), monocytes, granulocytes, platelets, CHO, amnion, aggregates, T cells, B cells, NK cells, magnetic beads, and more
Gentle processing enables >90% cell recovery The CTS Rotea system was used to concentrate The CTS Rotea sytem can achieve while maintaining cell viability through 500 million T cells in a starting volume of approximately 90% PBMC recovery from a T cell washing and concentration. High 1,000 mL down to 5 mL achieving 97% cell Leukopak bag in combination with a red blood reproducibility was demonstrated over 10 runs. recovery while maintaining viability of 94%. cell lysis buffer across multiple donors (n=7).
For more data, go to thermofisher.com/rotea
10
95% viability
200X
concentration
94% viability
High PBMC recovery from a Leukopak bag
200X T cell concentration
Viability and recovery after T cell washing and concentration
Enabling GMP compliance Cost-effectiveness of closed
modular systems
Gibco™ Cell Therapy Systems (CTS™) products are specifically designed to enable clinical and commercial cell and gene therapy manufacturing and are backed by testing and regulatory support.
CTS Rotea Single-Use Kit Regulatory Support Files (RSF) are available by request at thermofisher.com/regulatory
The RSF includes detailed information about the single- use consumable, including materials of construction, biocompatibility, extractable testing summaries, integrity of consumable sterility, stability testing, and instrument safety compliance standards
The CTS Rotea Counterflow Centrifuge and CTS Rotea Single-Use Kit are manufactured under ISO 13485 regulations, adhering to all compliance guidelines
The CTS Rotea GUI software can be locked for operator manufacturing mode
The OPC-UA interface, the industry-standard machine communication language, enables connection to an MES/LIM or 21 CFR Part 11–compliant system
The CTS Rotea system is a modular, closed cell therapy instrument that can be utilized from research through commerical manufacturing, enabling efficiency and
cost savings.
Closed systems reduce the cost of clean room space—a closed system that operates in a
Class C manufacturing facility can reduce the size of Class B lab space required for open processing systems by 90%.*
Modular designs enable increased instrument efficiency and utility—manufacturing processes can be optimized using technologies that are ideally suited to each process step. Time-consuming processes such as cell expansion can be decoupled from rapid processes such as buffer change and concentration, reducing
the investment in facilities and capital equipment by up to 70%.*
Avoid process development delays—utilizing the same system from research through process development and commercial manufacturing can help you avoid process delays associated with changing systems.
* Claims based on CAR T therapy, 7-day incubation, 2,000 patients per year
(Source: https://pdfs.semanticscholar.org/1589/c6e2b45417f03f1014ed189c77dd0da8676a.pdf).
Getting started with the Rotea system
Customer experience and support
SmartStart orientation includes:
Rotea system software training—covers GUI, protocol builder, simulation software, and CFC process model
Rotea system protocol development training
Creation of one custom protocol to suit your cells and application
Step-by-step explanation of instrument and software available tools using your custom protocol as an example
Detailed protocol builder training to enable you to customize off-the-shelf protocols or create new customized protocols
General instrument setup and operation
IQ/OQ package available with additional AB Qualification service that provides an on-site Field Service Engineer visit within 2 years of installation.
Field application scientists will work together with you to provide ongoing protocol development support.
Annual preventative maintenance and instrument service will be available through the Instrument Services team.
- Closed system–compatible media and reagents
Cell therapy workflows are varied and complex. To meet the demand for media and reagents suitable for closed systems, the design of our bioprocess container is flexible and adaptable. Gibco™ CTS™ off-the-shelf bagged media support closed cell and gene therapy manufacturing from clinical translation through commercial manufacturing.
Moving from open systems to closed systems may reduce the risk of cross-contamination, alleviating events impacting quality and increasing clinical and commercial manufacturing success. Gibco™ CTS™ AIM-V™ Medium, without phenol red and without antibiotics; Gibco™ CTS™ DPBS, without calcium chloride and without magnesium chloride; Gibco™ CTS™ DPBS, with calcium chloride and magnesium chloride; and Gibco™ CTS™ NK-Xpander™
Medium will help scale up or scale out your manufacturing process. Each formulation is available in flexible bioprocess container format suitable for aseptic integration into your workflow through sterile welding, MPC quick-connect, or Luer lock connections.
Closed system compatible—tubing polymers are compatible with market-leading sterile welding equipment to enable use in upstream and downstream applications
Seamless translation—CTS reagents are now offered in closed packaging to help reduce lead times and scale and close your process
Quality testing and regulatory documentation— reagents and single-use technologies comply with industry standards and are backed by regulatory documentation and support (Drug Master File and/or a Regulatory Support File, Certificate of Analysis, and Certificate of Origin)
Products that meet your need at every step of the workflow, from research through commercial manufacturing
Clinical trial kit production
Cell collection and tracking
Cell isolation and activation
CTS Rotea Counterflow Centrifugation System
CTS media and reagents
Cell engineering
CTS Rotea Counterflow Centrifugation System
Lentiviral production and purification solutions
Cell expansion
CTS media and reagents
CTS culture supplement
Clinical packaging, labeling, and distribution
Custom media and reagents
Gene editing solutions
Invitrogen™ Neon™ Transfection System
Gibco™ growth factors
Single-use technologies and bioreactors
Cold-chain logistics and cryogenic storage
Adeno-associated virus solutions
Invitrogen™ Lipofectamine™ transfection reagents
CTS Rotea Counterflow Centrifugation System
Cell wash and cryopreservation
CTS wash and cryopreservation reagents
Qualification and validation services
Clinical trial kit production
Clinical packaging, labeling, and distribution
Cold-chain logistics and cryogenic storage
Invitrogen™ Attune™ NxT Flow Cytometer
Cell characterization
Invitrogen™ Countess™ II Automated Cell Counter
Invitrogen™ EVOS™ M7000 Imaging System
qPCR instruments and next-generation sequencing
Identity, purity, and contamination assays
Potency assays
Cell line authentication and HLA typing
Genomic, proteomic, and cellular analytical tools
Additional resources
See the CTS Rotea system in action. Check out how-to videos and virtual demos at thermofisher.com/rotea
To view protocols and learn more about how to use the CTS Rotea system in different applications, go to thermofisher.com/rotea
For more information, or to request a quote, go to
SmartStart orientation training enables your success. Every CTS Rotea Counterflow Centrifugation System comes with SmartStart
orientation training to help your lab quickly become efficient at using your new CTS Rotea system. Led by professional trainers, the orientation provides interactive education that includes theoretical and hands-on training. Field application scientists train in your lab or remotely and cover a variety of topics around the instrument, software, and applications.
View recent webinars, application notes, handbooks, posters, and more in our Cell and Gene Therapy Learning Center, at thermofisher.com/cgtlearningcenter
For technical support or help, contact us at thermofisher.com/us/en/home/technical- resources
To request Regulatory Support Files, contact us at
See our product and service selection tool for a complete list of cell and gene therapy products and services at thermofisher.com/cellgenetherapytool
High-quality materials, services, and support offered every step of the journey, from discovery to clinical research to commercial cell and gene therapy manufacturing. Learn more at thermofisher.com/ctssupport
Learn about our solutions to help you achieve your cell therapy goals from research to commercialization at thermofisher.com/cellandgenetherapy
For more information about our latest technology offerings, go to thermofisher.com/cgtask
Ordering information
Product Cat. No.
Consumables
A47695**
A47679**
CTS Rotea Counterflow Centrifugation System + 2 year warranty (including OQ after PM) + IQOQ A50757* CTS Rotea Counterflow Centrifugation System + 2 year warranty (including PM) A50760*
CTS Rotea Single-Use Kit (10 pk) A49585
CTS Rotea Single-Use Kit (5 pk) A49313
CTS Rotea Hi-Flow Single-Use Kit (10 pk) A46575
CTS Rotea Hi-Flow Single-Use Kit (5 pk) A49239
Closed system–compatible media and reagents
CTS AIM-V Medium, without phenol red, without antibiotics (2 L) A4672701
CTS DPBS, without calcium chloride, without magnesium chloride (2 L) A1285602
CTS DPBS, with calcium chloride and magnesium chloride (2 L) A4737901
CTS NK-Xpander Medium (5 L) A5019002
Accessories
Rotea Kit Tube Clamps (100 pk) A49127
Rotea Kit Sterile Connectors (10 pk) A50110
Rotea Kit Sterile Sample Ports (10 pk) A50111
* North America, Europe.
** Rest of world.
thermofisher.com/rotea