Kytero 10 – Big changes start small

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.

“All beginnings are difficult” as the saying goes – but this was no acceptable state of affairs for development engineers at GEA. They put themselves in the shoes of creative product developers working on innovative pharma solutions with the help of centrifugal technology. How could the smallest quantities of product be reliably produced, tested and then scaled up – ideally as far as required? Time presented additional pressure. In 2020, Covid-19 vaccines had to be made available as quickly as possible. Single-use technology was in demand. This meant the GEA kytero, a new single-use disk-stack separator with an exceptionally compact design for use in laboratories and research facilities, came at just the right time. The first model in the series for bioreactors with a volume of 500 liters launched in 2021.

Single-use – the better way

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.

Research successes with kytero 500 in Berlin and Zurich

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.

The next chapter: GEA kytero 10, the world's smallest single-use disk-stack centrifuge

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.

Perfusion on a laboratory scale

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 reduces costs and increases 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.

Sustainability starts with collaboration

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.

Advantages of benchtop performance

World first on a laboratory scale: Compact benchtop device with high user-friendliness and advanced disk-stack technology
Central role in pharmaceutical development processes: Supports research and production of modern active ingredients in the smallest of spaces
Focus on new food: Process-safe basis for alternative nutrition concepts with minimal use of resources
Efficient cell and bacteria separation: Optimizes separation from fermentation broths for a wide range of cell cultures
Flexible and tailored to requirements: Also suitable for very small batches – ideal for early development phases and pilot trials
Seamless scaling: From laboratory size to large-scale production through consistent use of industrial standards
Cost and resource efficiency: Reduces the use of energy, water and auxiliary materials – even pure steam is not required
Maximum simplification: Reduced cleaning effort thanks to single-use concept – quick deployment with minimal space requirements