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Xuri™. Believe in better futures

Xuri™. Believe in better futures
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Xuri™. Believe in better futures

Product catalog summary
Introduction
GE Healthcare's Xuri™ cell therapy technologies are designed to enhance the development and manufacturing of cell-based therapies, aiming to accelerate access to innovative treatments for life-threatening diseases through integrated solutions from research to clinical application.
Engineering Innovation
The GE Global Research Center focuses on technological development to address global challenges and drive business growth, with operations in the USA, India, China, Germany, and Brazil.
Building the Infrastructure
GE's Enterprise Solutions team provides expertise in process development, product offerings, and facility planning to support cell manufacturing, as part of the Healthymagination initiative to improve healthcare quality, access, and affordability.
Collaborations
GE collaborates with institutions like Karolinska University Hospital and the University of California, San Francisco, to advance cell therapy technologies and address challenges such as the availability of blood-forming stem cells.
From Research to Manufacturing
Xuri technologies support all stages of cell therapy projects, adhering to USP<1043> standards to ensure a smooth transition from research to clinical application.
Faster to Clinic
GE's products are designed to expedite therapy delivery by easing regulatory paths and optimizing processes for scalable solutions, with technical support to maximize production efficiency and control costs.
Cell Isolation and Expansion
Ficoll-Paque™ PREMIUM and Percoll™ PLUS are used for cell isolation, offering flexibility and consistent performance. Xuri Cell Expansion Systems provide scalable solutions for cell culture, ensuring high cell densities and minimal contamination risk.
Cellbag Bioreactors
These single-use, functionally closed cell culture bags are designed to minimize cross-contamination and are equipped with sensors for optimal control, available in various sizes to accommodate different culture volumes.
Conclusion
GE Healthcare's Xuri cell therapy technologies offer comprehensive solutions for cell-based therapy development and manufacturing, focusing on innovation, scalability, and regulatory compliance.
Overview
The document provides an overview of the Xuri Cell Expansion System W25, highlighting its specifications, functionalities, and applications in cell therapy, particularly for T-lymphocyte expansion and mesenchymal stromal cell (MSC) isolation and expansion.
System Specifications
The Xuri W25 Base Unit includes features like rocking speed control, temperature measurement, and dual hard drives for data storage, designed for scalability with multiple unit connections for larger operations.
Functional Components
The system includes the Xuri W25 Pump for media perfusion, the Cellbag Control Unit for gas flow and pH/DO measurement, and the UNICORN software for process monitoring and remote operation.
Cell Expansion
The Xuri Cell Expansion System W25 is optimized for T-lymphocyte expansion, offering advanced control and traceability suitable for regulated environments, supporting scale-out and scale-up operations.
MSC Isolation and Expansion
Ficoll-Paque PREMIUM is used for MSC isolation, emphasizing the benefits of the 1.073 density medium for higher yield and reduced expansion time. The Xuri MSC Medium Serum-free/Xeno-free supports sustainable MSC cultures without animal-derived components.
Regulatory Compliance
The system and its components adhere to USP <1043> standards, facilitating regulatory submissions and ensuring reproducibility without revalidation.
Imaging and Analysis
GE's advanced imaging technologies, including the Cytell Cell Imaging System and IN Cell Analyzer, enhance disease understanding and support cell therapy research.
Environmental and Operational Parameters
The document specifies operational ranges for temperature, humidity, gas flow, and other critical parameters, ensuring optimal performance and accuracy in cell culture processes.
System Specifications
The Xuri Cell Expansion System W25 Pump operates with a flow-rate range of 100 ml to 144 l/d, with an accuracy of ± 0.1 ml/min plus 5% of the read value after calibration. It supports tubing dimensions with an inner diameter of 0.5 to 4.8 mm and a wall thickness of 1.6 mm. The Xuri Cell Expansion System W5 is designed for human cell expansion in suspension, with specific operational conditions and construction details.
Ordering Information
The document provides a detailed list of products, including Ficoll-Paque PREMIUM, Percoll PLUS, Xuri IL-2, Xuri MSC Medium, and various components of the Xuri Cell Expansion System, along with their catalog numbers.
References
The document cites studies related to cell expansion and immunotherapy, highlighting the use of bioreactors and automated systems in clinical-grade cell production.
Legal and Trademark Information
GE and its subsidiaries hold trademarks for various products mentioned, clarifying that the products are for research use only and not for therapeutic or diagnostic procedures.
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Catalog excerpts

Xuri™. Believe in better futures-1

Xuri . Believe in better futures. ™ Finding solutions. Advancing breakthrough cell therapies.

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Xuri™. Believe in better futures-2

Our commitment Engineering innovation GE Global Research Center is the hub of technology development for all of GE’s businesses with employees representing many disciplines of science and technology. Our scientists and engineers redefine what’s possible by finding answers to some of the world’s toughest problems and driving growth for our businesses. We innovate twenty-four hours a day, with sites in Niskayuna, New York; San Ramon, California; Bangalore, India; Shanghai, China; Munich, Germany; and Rio de Janeiro, Brazil. For more information visit www.ge.com/research Building the infrastructure...

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Xuri™. Believe in better futures-3

Seamlessly go from research to manufacturing To bring a cell therapy product from research to the clinic and into commercial-scale manufacturing quickly, on budget, and with minimal process optimization both the regulatory and technical requirements of increasing scale should be taken into account from the initial process setup. We understand the requirements for each phase of cell therapy production and our products and services ease the progression to commercialization because they can be readily incorporated in to cell manufacturing SOPs. .■Clinical research .-Process develoment • Facilitated...

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Xuri™. Believe in better futures-4

Immunotherapy: Cell isolation Making immunotherapy a reality GE Healthcare products maximize your chances of success in cell therapy manufacturing by helping to preserve as many precious cells as possible during both the initial cell separation and the expansion of immune cells. They can be readily included in cell manufacturing SOPs facilitating regulatory approval and easing the progression from research to manufacturing. Cell separation Cell selection Cell activation and expansion Cell harvest and concentration Cell infusion into patient Typical immunotherapy workflow. Cell isolation With...

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Immunotherapy: Cell isolation Ficoll-Paque PREMIUM Percoll PLUS Ficoll-Paque PREMIUM products are sterile, ready-to-use density centrifugation media solutions manufactured under a Quality Management System certified to ISO 13485:2003 and follow USP <1043> standards for facilitated adoption into cell therapy manufacturing protocols*. Ficoll-Paque PREMIUM solutions are optimized to obtain different types of mononuclear cells from peripheral blood, bone marrow, and umbilical cord blood by density gradient centrifugation. For flexibility and in order to maximize recovery of precious patient cells,...

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Immunotherapy: Cell expansion Cell expansion GE Healthcare cell expansion systems, bioreactors, and reagents are designed to address the technical and manufacturing needs of laboratories and units producing cells for cell therapy and progressing towards scale-out or scale-up. The systems are suitable for use in regulated environments and can be used in clinical research, process development, and manufacturing. Xuri Cell Expansion Systems help you progress the manufacture of cells from research to the clinic in a seamless way thanks to their scalability and the functionally closed Cellbag™ bioreactors....

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Immunotherapy: Cell expansion Xuri Cell Expansion System W5 Xuri Cell Expansion System W5 (formerly known as WAVE Bioreactor™ 2/10 System) is ideally suited to research-scale cell culture or for the early stage of scale-up and scale-out prior to the commercial manufacture of cell-therapy products. This easy-to-use system allows production of large numbers of cells in a single-use Cellbag bioreactor more efficiently and cost-effectively than manual tissue culture flask-based systems. The system is suitable for culture volumes from as low as 300 mL up to a total of 5 L. Its use has been optimized...

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Immunotherapy: Cell expansion Xuri Cell Expansion System W25 Xuri Cell Expansion System W25 has been specifically designed for cell therapy manufacturing applications. To allow for easy progress from the research environment without the need to re-validate, Xuri Cell Expansion System W25 utilizes the same single-use Cellbag bioreactors as the Xuri Cell Expansion System W5. The Xuri Cell Expansion System W25 is suitable for processing volumes from 300 mL up to 25 L using the appropriate base tray and Cellbag bioreactor. This functionally closed system is based on proven wave rocking technology...

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Immunotherapy: Cell expansion Xuri Cell Expansion System W25 offers the following advantages in addition to those provided by the Xuri Cell Expansion System W5. • Advanced control of cell expansion through process monitoring and remote operation with UNICORN software. • Suitability for use in a regulated environment with full operational traceability and adherence of the software to CFR part 11 and GAMP5. • Backup storage of data in the base unit. • Minimized hands-on time with control of up to three systems simultaneously from a single UNICORN client. Connection of up to 32 systems to one database...

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Immunotherapy: Cell isolation Making stem cell therapy a reality Mesenchymal stromal cell isolation The relatively easy harvesting and expansion procedures of mesenchymal stromal cells (MSCs) together with their ability to differentiate into osteoblasts, adipocytes, and chondroblasts under standard in vitro conditions, may make them suitable for several autologous and allogeneic transplantation settings. Factors challenging the adoption of MSCs for cell therapy at a commercial level are the variability in cell culture conditions, safety, and the long term supply issue, all of which result from...

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Xuri™. Believe in better futures-11

Immunotherapy: Cell expansion Xuri MSC Medium Serum-free/Xeno-free has been developed to ensure sustainability of MSC cultures when reaching higher volumes and broader applicability in cell therapy. It enables safe and efficient expansion of MSCs after isolation from different tissue origins (including bone marrow, adipose tissue, and umbilical cord) without the use of animal-derived components or undefined serum (Fig 8). Xuri MSC Medium Serum-free/Xeno-free is intended for use with Xuri MSC Attachment Solution for the expansion of cells to the high numbers required for therapeutic doses, without...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.