Description
This functionally closed system is based on established WAVE rocking technology that provides gentle mixing and aeration to the culture, resulting in high cell densities whilst minimizing the risk of contamination. Seeing is believing Watch the video How to best culture T cells for cell therapy manufacturing for a step-by-step guide on how to optimize your cell therapy manufacturing process with Xuri Cell Expansion System W25. Goodbye to manual transfers Scale-up without tedious sequential transfers using single-use Cellbag bioreactors that can accommodate working volumes up to 25 L, ensuring an entire therapeutic dose can be obtained in a single bioreactor. This not only reduces the risk of contamination and operator variability but frees up your time and work space too. Take control of process parameters Process parameters such as rocking speed, dissolved oxygen (DO), pH, and perfusion rate are monitored and controlled either locally or remotely. Methods can be created, edited and saved while alarms can be configured to alert you when pre-set conditions are met or deviations from defined parameters occur. Learn how to write a customized expansion protocol in our advanced UNICORN™ Method Editing for Cell Therapy on Xuri™ W25 (UNI2) online course. Supports regulatory compliance Included and supplemental documentation, optional installation and operational qualification (IQ/OQ) services, plus 21 CFR Part 11 and Good Automated Manufacturing Practice (GAMP) 5 compliant ready UNICORN software ensure your system meets the demands and standards of a regulated envfironment. Equipment services Opti Run service solutions offer a comprehensive range of options that can be customized to your asset-management needs and desired outcomes. Learn more about service agreements and lifecycle support for your equipment. Change Control Notifications Our web-based Change Control Notification (CCN) service ensures that you are notified about changes that could potentially impact your product or process. The CCN service is available for free by subscription at the Regulatory Support website.
