In the biopharmaceutical industry, in which demand for highly varied monoclonal antibodies (mAbs) and vaccines continues to rise, fast product development and production rollout is paramount.
The yearly output of biopharma protein products amounts to more than 17 million litres worldwide.1 Surviving in this dynamic market offers manufacturers significant growth opportunities … but also presents considerable challenges.
In this production landscape, innovative solutions such as GEA kytero single-use perfusion separators offer a transformative approach to processing that’s setting new standards in terms of productivity and cost-effectiveness.
Addressing industry challenges
Biopharmaceutical production is characterised by intricate planning and substantial investment. Both are necessary to cope with the complexity of sensitive processes in research and development (R&D) facilities and cleanrooms.
Added to this are the high costs associated with providing fresh cell cultures, maintaining an extensive infrastructure and running operations with highly qualified personnel.
Operators must strike a balance between cost optimisation and the need for flexible and productive processes. Integrating new technologies into process lines to increase efficiency is not an easy feat; it often requires additional investment and could, potentially, adversely affect R&D, rollout and scale-up.
Advanced process technology concepts, as demonstrated by the GEA kytero separator range, mark a significant step forward by providing pharmaceutical manufacturers with avenues to improve their operations with less risk.
Disk stack single-use centrifuges for perfusion
The new GEA kytero perfusion separators enable the concept of continuous processing during the crucial phase of cell separation in biopharmaceutical processes.
At this stage, after exponential cell growth in the reactor, the cells are taken from the bioreactor, separated from the culture medium — which contains the target product — and returned to the bioreactor.
Introducing a continuous process can significantly improve both productivity and cost-efficiency, enhance product output and reduce operating costs, especially when the benefits of perfusion are combined with single-use disk stack separation technology.
The perfusion process: a game-changer
The economic potential of the perfusion method is widely recognised, offering increased output, shorter time-to-market and significantly lower operating costs.
GEA responded to the needs of the market by being the first technology company to produce single-use separators for perfusion.
The proven technology used in large-scale pharmaceutical centrifuges from GEA — the revolving separating bowl with an integrated disk stack — has been transformed into an easy-to-handle single-use element with corresponding feed and discharge lines that is simply replaced after a production run.
As no hygienic cleaning or autoclaving is required, the machine can be ready for the next continuous process run in just a few minutes.
The separators do not require any utilities except power and an air supply; plus, they occupy significantly less floorspace than comparable alternating tangential flow (ATF) systems.
The compact, closed, 100% biocontainment-proof separating unit and the innovative non-contact drive system are ideal for biopharmaceutical applications.
Facilitating start-up and scale-up
For the biopharma industry, this type of single-use system can be seen as an opportunity to implement perfusion processes with comparatively little effort and cost — and remove many of the typical entry barriers.
GEA kytero separators are available for bioreactors with capacities of 500 L and 2000 L, thus enabling process trials to be done with reduced quantities of expensive cell cultures.
A new separator for smaller R&D applications — suitable for both batch and perfusion test processes — is expected to be available in early 2025.
The test and production results achieved with the kytero 500 can be scaled-up to the larger kytero 2000 — and even to industrial production with stainless-steel plant — by maintaining the technical principle of disk stack separation, which ensures safe tech transfer and facilitates validation.
Manufacturers aiming to implement perfusion processes and expand their position in the dynamic pharmaceutical market are encouraged to explore the benefits of single-use perfusion technology in their operations.
GEA will showcase the GEA kytero Separator 500 Perfusion at ACHEMA 2024 in Frankfurt, Germany (10–14 June), in Hall 4 on Booth G66.
Reference
- www.bioprocessonline.com/doc/s-bioprocessing-year-in-review-key-takeaways-0001.
