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Xuri™ Cell Expansion System W5
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Xuri™ Cell Expansion System W5 - 1

Cell expansion Xuri™ Cell Expansion System W5 Xuri Cell Expansion System W5 is a cell expansion system for small-scale cell culture or for the early stage of scale-up and scale-out for manufacturing of cell-therapy products. This easy-to-use, reliable system allows the manufacture 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 0.3 l up to a total of 5 l. Xuri Cell Expansion System W5 offers the following benefits: • Minimized risk of culture contamination and cross-contamination of samples • Production of high cell densities with confidence • Easy protocol optimization for future commercial-scale manufacture • Minimal cost of disposables System benefits Fig 1. Xuri Cell Expansion System W5 is an easy-to-use system for cell culture of volumes from 0.3 l up to 5 l. Minimized risk of culture contamination and cell cross-contamination Easy protocol optimization for commercial manufacture The system is functionally closed and cells are grown in a single-use Cellbag bioreactor, which reduces the risk of contamination. Minimal validation is required. Cells only come into contact with disposable, sterile biocompatible plastics. This system can be easily connected to other closed cell-culture units using sterile welding. With an easy-to-use interface, simple setup, and robust build, Xuri Cell Expansion System W5 is well suited for researchscale production of cells and for protocol optimization in preparation for future commercial-scale manufacture of celltherapy products. Production of high cell densities with confidence Rapid production of up to 107 viable cells/ml of culture is easy when using perfusion. This means that the entire dose of cells for one patient can be obtained in one bag instead of being divided between multiple tissue-culture flasks. This also reduces the risk of contamination. Minimized cost of disposables Since cell cultures can reach target concentrations in one Cellbag bioreactor, the costs of disposables can be a fraction of those incurred when using other methods. Cellbag bioreactor can be customized, allowing Xuri Cell Expansion System W5 to be easily incorporated into existi

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Xuri™ Cell Expansion System W5 - 2

Cellbag bioreactors The rocking motion of the platform induces waves to mix and transfer oxygen to the culture medium to create an optimal environment for cell growth (Fig 2) and to reach high cell densities. The gentle wave action limits shear stress on the cells in comparison to traditional stirred-tank bioreactors. Cellbag bioreactors (Fig 3) are intended for single-use and are suitable for cGMP production of human cells for cell-therapy applications. The components are similar to those used for biological storage bags and meet USP Class VI specifications for plastics. Inflated plastic...

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Xuri™ Cell Expansion System W5 - 3

Quantity Code number 1 29-0368-37 Ordering information Product Xuri Cell Expansion System W5, Base Unit Xuri Cell Expansion System W5, Perfusion Controller Xuri Cell Expansion System W5, CO2/Air Controller Xuri Cell Expansion System W5, Lid Xuri Cell Expansion System W5, Filter Heater Xuri Cell Expansion System W25, Data file 29-0618-52 Disposable Cellbag bioreactors for 28-9511-36 WAVE Bioreactor™ systems, Data file

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Xuri™ Cell Expansion System W5 - 4

For local office contact information, visit www.gelifesciences.com/contact www.gelifesciences.com/xuri GE Healthcare UK Limited Amersham Place Little Chalfont Buckinghamshire, HP7 9NA UK Xuri Cell Expansion System W5 is not a medical device nor CE marked and should not be used in diagnostic processes. Drug manufacturers and clinicians are responsible for obtaining the appropriate IND/BLA/NDA approvals for clinical applications. GE and GE monogram are trademarks of General Electric Company. Cellbag, and Xuri are trademarks of GE Healthcare companies. Cellbag bioreactors with integrated...

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