The complete ScaleReady workflow: how everything fits into one scalable process
Built around the breakthrough advantages of G-Rex® closed-system bioreactors, the ScaleReady workflow was created specifically to produce immune cells such as T cells, natural killer (NK) cells, and hematopoietic cells. True linear scalability means that the same protocols established during research will work during large-scale production.
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The LOVO and Cue Cell Processing Systems are for laboratory use only. Unless the user has obtained advance clearance or approval from the appropriate regulatory agency, cells processed on this system are not intended for diagnostic purposes, direct transfusion, or for use in the production of therapeutic products or vaccines for clinical use. For applications requiring regulatory clearance or approval, users may request the required LOVO or Cue technical documentation from Fresenius Kabi to support their submissions. Refer to the LOVO Cell Processing System Operator’s Manual and Cue Cell Processing System User’s Guide for a complete list of warnings and precautions associated with the use of these products. The Cue Cell Processing System, with use of Research Use Only (RUO) disposable product, is not for human use. Cells processed using the RUO set are not for production of a therapeutic product or vaccine, clinical use, or direct transfusion to a patient. The sterility of the RUO set pathway cannot be guaranteed.