May 19, 2025
In a world of change, in which sustainability and resource efficiency are central pillars of responsible corporate strategies, innovative solutions are increasingly important. What can be done to make the development faster, more cost-efficient and environmentally friendly? With the GEA kytero 10, researchers and developers in the biopharmaceutical, food and new food industries now have the latest generation of a powerful accelerator at their disposal.
The principle of single-use for components that come into contact with cells, culture media or product has been a central feature of the kytero product line ever since. On the one hand, it simplifies process validation considerably: Cleaning, sterilization and qualification are no longer necessary. This enables fast, flexible product and process changes. On the other hand, single-use is also convincing in terms of resource efficiency: Complex automatic cleaning systems such as Cleaning in Place (CIP) and Sterilizing in Place (SIP) become superfluous – including their consumption of energy, water and cleaning agents. The cell treatment itself is so gentle and efficient that it ensures both a high yield and a viable cell harvest.
The single-use system demonstrates its strengths in intensive research applications. For example, the GEA kytero 500 proved its worth in a cell harvesting setup as part of a 200-liter cell fed-batch process as well as a 100-liter perfusion process over 14 days at ProBioGen AG in Berlin. The internationally active company for contract development and manufacturing (CDMO) services challenged the system with demanding parameters – including high cell densities – to see if it could overcome the current limitations of conventional depth filtration systems. The outcome: very good results as a primary clarification system. It also excelled in intensified processes with higher cell densities, remarkably low space requirements and easy handling. The sophisticated plug-and-play design made everyday laboratory work much easier.
ProBioGen in Berlin and the Zurich University of Applied Sciences (ZHAW) tested the kytero 500.
The kytero 500 was also successfully used at the Zurich University of Applied Sciences (ZHAW). The aim was to optimize clarification efficiency and reduce filter systems as well as the amount of material, space and work required. Specifically, the separator was used to separate immunoglobulin G – antibodies that fight pathogens in the blood – from the cultivation medium previously produced in a disposable bioreactor. The system was ready for operation after just five minutes. The subsequent analysis showed that the medium was completely free of solids – the cell biomass was efficiently and completely separated.
It’s a big sensation in the small package. GEA’s next iteration is a user-friendly benchtop device with state-of-the-art, high-performance disk-stack separation technology that can be connected to bioreactors with a capacity of 1 to 10 liters. Thus, kytero 10 continues the path of the single-use systems and closes the gap to the smallest production and development approaches. There is no better way to save resources and achieve high-quality results with minimal quantities of expensive product. All this comes with reliable upscale and the certainty that researchers and developers will have the best starting conditions to make the world a little better with their ideas and innovations.
The new kytero 10 separators enable continuous operation over the perfusion period and continuous clarification of the fermentation broth. The clarified liquid, which usually contains the product, is continuously removed from the process and fed to the next process stages. Exceptions are bacterial processes and new food applications, where the cells are the valuable product. In these cases, the concentrated biomass is gently returned to the bioreactor, ensuring high vitality and productivity.
Continuous processing not only reduces the size of the bioreactor and cuts costs, but it also significantly increases productivity per liter of reactor volume (thanks to the higher cell density). Cells are returned to the bioreactor while the clarified liquid is removed with the product; production can run continuously for weeks. This makes it possible to bring new products to market more cost-effectively and quickly.
One highly anticipated use of the kytero 10 is in the development of vaccines and cancer-targeting monoclonal antibodies (mAbs). The GEA kytero 10 separator is designed for exactly the high-intensity, continuous cell separation these processes require. Life-saving drugs can now be developed and produced faster and more cost effectively.
GEA pursued the goal of developing technology together with practitioners – in close cooperation with CDMOs, research institutions such as the ZHAW and numerous laboratories worldwide. The continuous exchange with specialist users has contributed significantly to the further development of the kytero product line. Today, kytero 10 and the larger models kytero 500 and kytero 2000 are available for flexible use in conventional batch mode as well as in extended perfusion mode – as reliable tools for more efficient, faster and more resource-efficient product development.