Scaling up is all about being able to do on a large scale what is already possible on the small scale. But sometimes you need to take a different route to ensure that the steps you take on the lab scale are immediately compatible with the rest of the trajectory. This realization stimulated the team at GEA to extend their range of Kytero single-use centrifuges with a smaller version specifically designed for the first steps in the process development trajectory.  

These centrifuges are developed for Pharma and Biotech, but also for New Food applications, such as cultured meat and precision fermentation. Here, separating and/or concentrating cells from a culture medium is an essential step. ‘For a long time, filtration was the dominant separation technology, but it comes with many disadvantages’, says Rüdiger Göhmann, Product Group Manager Pharma, Extraction, Chemicals & Minerals at GEA. ‘This created strong market demand for alternative techniques such as single-use centrifuges. We responded by developing our Kytero line, and to be honest, in the past we have underestimated the need for scalability of our stainless steel centrifuges to smaller lab sizes.’  

For industry, the development of a production process starts in the lab. Whatever is developed there, should be fit to translate to pilot scale and then to commercial production volumes. ‘But that implies that the technology you aim to use for production is also available on a lab scale’, Göhmann explains. ‘Because otherwise, you will have to change the technology along the way and that is undesirable, particularly when it comes to Pharma and Biotech because of the strict regulatory requirements for these products and processes. It is therefore essential that you can use the same technology on every production scale, allowing you to make relevant predictions on a lab scale.’ 

Lowering speed

GEA, like many other equipment manufacturers, has a long history of working with stainless steel. Therefore, the development of single-use technology and products came with quite a learning curve. Göhmann: ‘Working with plastics means working with completely different parameters. For example, when it comes to mechanical stress on your materials. That’s why you have to reduce speed. That took some getting used to, because with stainless steel the mantra was always: the faster, the better. But with our single-use centrifuges we see that the results are mostly as good at lower rpms, especially when it comes to mammalian cells.’  

The Kytero line employs a completely new drive system that offers important advantages, says Edwin Telgenkamp, Account Manager Netherlands at GEA. ‘We use a so-called breezeDrive® system, in which all rotating parts move contactless, and no mechanical seal is required and therefore biocontainment proof, so it’s a 100% closed system.’ The 10L lab version can already run continuously for 28 days in perfusion processes without any problems and according to Göhmann, it can continue for much longer. ‘It’s just that the cells don’t last forever, but the technology can continue to run indefinitely.’  

With this new addition to the Kytero line, customers can make very conscious choices, Telgenkamp emphasizes. ‘We have no preference; it is up to the customer to decide whether they prefer stainless steel or single-use. But whatever they choose, we now enable them to continue working with exactly the same technology throughout the entire scale-up process.’ They just have to wait for a little while; market launch of the Kytero 10L is planned for Q1 2025.