21 Human blood plasma fractionation

SINGLE-USE PROCESSING

GEA kytero® Separator

GEA’s single-use separation concept transfers acclaimed disk stack separation technology as used throughout the GEA pharma aseptic and pure series – to single-use cell har- vesting and other applications for R&D, pilot plants and small production.

Add more yield to your process kytero® stands for maximum separation efficiency with extremely gentle product handling. This unit creates new ways for processing cell culture fermentation broths with a yield of 98 percent and more. This type of technology is in demand for pilot plants, uni- versity laboratories, and small-scale production with biopharmaceutical manufacturers worldwide, since it is based on the proven technologies of industrial disk stack separators.

No CIP/SIP required All materials in contact with the product – disk stack clarifier bowl, connection tubes and bags – are part of the single-use exchange set and form a closed system that is 100% bio- containment-proof. For every batch a new set is clipped on.

Scale up your success Use the GEA kytero® Separator 500 as R&D and small-batch machine and go into production with the kytero® 2000. The GEA kytero® 500 can process 500 L of input feed in a single batch. Test results from smaller batches can be upscaled to that capacity or transferred to the GEA kytero 2000 for higher capacities. Success is as simple as that.

Efficient cell harvesting in a snap

GEA kytero®: More yield. No CIP/SIP.

22 Single-use processing

Save filtration effort and cost in both clarification steps. The high separation efficiency of the GEA kytero® solution has been tested in cell-based immunoglobulin mAb production at Zurich University of Applied Sciences (ZHAW).

Reduce your dependency on filtration

The results show that facilities can reduce the amount of filter area for cell clarification by 100 % in the primary cla- rification step. Up to 50 % filter area can be reduced in the second clarification step. Apart from the cost of filter ma - terial, this saves considerable space and handling time as well as effort for backup systems, logistics and personnel.

Applications: • Cell harvesting • Gene therapy • e.Coli • many more

23 Single-use processing

Easy operating concept, saving time, space and labor The GEA kytero® solution offers minimum demands on space, time and labor in intensively used pharma produc- tion environments. Set up within minutes and without special tools, the machine operates in a continuous process with fully adjusted components to ensure controlled processing to the parameters set manually or by PLC. All process data are stored and digitally labeled for easy traceability of each batch.

100 percent biocontainment-proof GEA kytero® is equipped with a unique contact-free, no-con- tamination drive system. The revolutionary GEA breezeDrive® has been developed by GEA engineers and drives the bowl without any shafts and bearings or mechanical seals – the failsafe way to ensure an absolutely pure product. This GEA innovation is also appreciated for the very low noise level in the production or lab environment.

Fits into every cleanroom In contrast to conventional single-use solutions, the GEA kytero® skid includes connections, pumps, controls and HMI. The system can be stored outside of the cleanroom and set up for the next batch in only five minutes, with no utilities required other than power supply.

Easy handling – batch-ready in 5 minutes

24 Single-use processing