GEA: new kytero® single-use perfusion separators

GEA is a pioneer in cell separation and recycling in biopharmaceutical perfusion processes. For the first time, perfusion disc separators for continuous production and faster processing can be implemented in biopharma cell harvesting processes based on labour-saving, easy-to-use single-use devices.

No time-consuming CIP and SIP cleaning and a contactless drive system

The newly introduced perfusion separators in this series offer the same advantages as classic disc separators for fed-batch processes: However, CIP and SIP cleaning is no longer necessary, meaning that the machine is ready for the next continuous process run in just a few minutes. The separators do not require any media other than electricity and air supply. Their compact design and operation from one side enable operation in any plant, especially in comparison to classic ATF or depth filtration systems. As with all comparable technologies, neither floor space nor personnel resources need to be reserved for changing the single-use parts. In addition to the innovation of a compact, closed, 100 per cent contamination-protected separation system, the GEA kytero® centrifuges have an innovative, non-contact drive system, which ensures safe operation even with high biocontainment requirements.

Great demand, especially in the production of vaccines and monoclonal antibodies (mAbs)

GEA developed the new kytero® single-use perfusion separators to optimally support the biopharmaceutical industry in the dynamic biopharmaceutical market with robust and easily scalable upstream processes. The new kytero® single-use perfusion separators are designed for high-intensity, continuous cell separation. With good reason, as the demand for vaccines and various monoclonal antibodies (mAbs) is continuously increasing in the biopharmaceutical industry. Monoclonal antibodies are known as ‘targeted therapies’ because they target specific proteins on the surface of cells. They are successfully used to treat cancer and other serious diseases. The annual production of biopharmaceutical protein products amounts to more than 17 million litres worldwide.

First single-use disc centrifuge for perfusion

The cultivation of cells in the bioreactor and the subsequent extraction of the product protein is the most important upstream process in biopharmaceutical production. In a continuous perfusion process, fresh culture medium is regularly added and an equal amount of clarified fermentation broth is removed from the process without damaging cells. The new GEA kytero® single use perfusion separators enable continuous operation over the perfusion period and continuously clarify fermentation broth. This contains the product and is removed from the process and fed to the next process stages.  The concentrated biomass is gently returned to the fermenter, ensuring high vitality and therefore high productivity.

Continuous means cost-efficient

Continuous processing optimises production time and reduces the effort involved in starting biopharma processes. Operators no longer have to wait for the end of a batch run to separate the cells and extract the target protein - the active pharmaceutical ingredient (API) - from the product-containing medium. Instead of discarding the cells, they are returned to the bioreactor so that production can run for weeks rather than days, delivering a product from day one.

This innovation allows new products to be brought to market faster and proven products to be delivered without losing valuable time. Importantly, the same cultured cells are reused throughout the multi-week process and do not need to be re-cultured for successive batches.

Great potential of the perfusion process for the biopharmaceutical industry

The economic potential of the perfusion method is globally recognised: Higher productivity, shorter time-to-market and significantly lower operating costs are achievable. GEA has responded to the needs of the market: GEA kytero® perfusion separators for single use production are the first of their kind. The proven technology of GEA pharmaceutical centrifuges in large-scale production, the rotating centrifuge bowl with integrated disc pack, has been transformed into an easy-to-handle single-use separator unit with corresponding inlet and outlet lines, which is simply replaced after a production run. As CIP and SIP cleaning is no longer required, the machine can be ready for the next continuous process run within five minutes. Apart from electricity and air, the separators do not require any further operation and take up significantly less floor space than comparable ATF systems. The compact, enclosed bowl system and an innovative, non-contact drive system are ideal for biocontainment biopharma applications.

Pioneering single-use convenience

In the GEA kytero® series, GEA's proven disc technology has been implemented in particularly compact machines with an easy-to-handle single-use separation unit that contains the entire disc pack. This separating unit and all associated feed and discharge lines - i.e. parts that come into contact with the product - are simply replaced in one go after a production run, thus offering maximum convenience and protection against contamination. Gamma-treated exchangeable cartridges are available as an option.

GEA kytero ® separators for the smallest P&C set-ups up to 500 and 2000 litre variants

The GEA kytero ® separators are available in 500-litre and 2000-litre versions and thus enable process trials with economically reduced quantities of expensive cell strains. A new Separator R, which is suitable for both batch and perfusion fermenters, will be launched in early 2025.

Test users: upscaling enables previous limits to be overcome

Test users of GEA kytero® single-use centrifuges have found that this concept is capable of overcoming previous limitations. The test and production results achieved with these process components can be scaled up to the larger single-use model variants and even to industrial production with classic, self-cleaning stainless steel separators from the renowned GEA pharma aseptic and GEA pharma pure series - always while retaining the market-proven principle of separation using a disc centrifuge, which ensures safe process transfer and facilitates validation.