The device is suitable for animal cell and gene therapy processes, as well as for pilot plants, university laboratories, in R&D environments and small-scale production, and biopharmaceutical manufacturing
At the Single-Use Conference in the Netherlands in September, GEA introduced its kytero separator, designed for the biopharmaceutical single-use industry. The separator is designed for obtaining fermentation solutions and cell cultures and is equipped with the company's Westfalia Separator disk stack technology, which it says ensures increased yield, high separation efficiency and gentle product handling. The device is designed to combine the performance of the company's larger stainless steel pharmaceutical centrifuges with the benefits of disposable separation.
This type of equipment is suitable for animal cell and gene therapy processes, as well as for pilot plants, university laboratories, in R&D environments and small-scale production, and biopharmaceutical manufacturing, as it relies on centrifugation to significantly reduce filtration dependency. In centrifugation, unlike filtration, separation of the medium is not achieved by filter media (filter plates and filter cloths), but by utilising the centrifugal force that occurs in conjunction with the disc pack for increased clarification efficiency. The mobile plug & produce unit also fits into any cleanroom, the company says.
The company deliberately chose the conference in Leiden to unveil the technology. Andreas Biewald, GEA Product Manager Sales and Rüdiger Göhmann, GEA Product Group Manager and Edwin Telgenkamp, GEA Account Manager from the Netherlands, were highly satisfied with the response. "Immediately after our presentation, there were many inquiries. The response showed us that with the GEA kytero we are entering a real gap in the market and can cover an application that is new to us," Göhmann said.
The device is designed to be user-friendly and easy to handle. All elements in contact with the product, such as hoses and containers, are made of recyclable material and are replaced after use. This mitigates cross-contamination and enables hygienic harvesting of the cells. The change of the single-use parts is easy, the company says, owing to aseptic connector systems. The design of the aseptic connector system additionally makes the exchange of single-use components more efficient.
The device's small footprint makes it highly mobile and minimises the need for storage or production space. Buffer tanks are also not required. The elimination of CIP (clean-in-place) and SIP (sterilise-in-place) also eliminates the cost of chemicals and water, especially water-for-injection (WFI). In addition, the energy and labor required for cleaning and sterilisation are eliminated.
Set-up and changeover time (five to ten minutes for preparation) is minimal. No auxiliary equipment such as water, buffers or tanks are required.
The noise level is less than 69 dBA, while the unavoidable temperature increase of the product during centrifugation is less than two degrees.
On average, the company says, a 500-litre batch of animal cells is processed in about four hours.