As growing strain on pharmaceutical technology necessitates more efficient practice, Alfa Laval has launched the CultureOne, a premium separator system for single-use cell culture processing.
According to Bioplan Associates, single-use bioprocessing technologies now dominate the pre-commercial manufacturing space. However, Alfa Laval believes that many companies have not been able to make the transition to ‘full-single-use’ when harvesting proteins due to the lack of a single-use disc-stack centrifuge. The CultureOne overcomes this challenge and is said to make it easier for biopharmaceutical manufacturers processing smaller capacities.
Alfa Laval is also working to ensure that the launch of the product is backed by a resilient supply chain and continuously high stock levels of components, amid concern the pandemic is placing strain on supplies of single-use technologies.
While advocacy of single-use plastic centrifuges is growing, stainless steel culture separators remain the current industry standard. According to Alfa Laval, this is limiting operational time for many pharmaceutical companies, as well as adding costs for chemicals due to the need for sterilisation between each cycle.
Plastic systems, placing a new disk stack in the centrifuge bowl each cycle, bypass the need for sterilisation and offer greater flexibility when producing new medicines – a crucial consideration in the current climate.
However, traditional single-use centrifuges have also been subject to similar limitations on operating time. Though the need for sterilisation is negated, until now, these centrifuges have only been available in batch processing formats – requiring frequent manual ejection of waste material. Efficiency is once again hampered by the necessity for internal access mid-cycle.
In response to these challenges, Alfa Laval has developed a solution that effectively addresses the shortcomings of both traditional stainless-steel and existing single-use centrifuges, achieving maximum culture yields with minimal downtime between cycles.
The CultureOne is comprised of a portable metal frame that houses the Spinsert, the core centrifuge bowl containing multiple single-use plastic UniDiscs, which come pre-sterilised to circumvent the need for sanitisation between cycles.
Moreover, unlike existing batch processing systems, the CultureOne is able to operate continually without necessary access to the internal bowl. The TopStream feature discharges solids continuously without the need for any human interaction. UniDisc and TopStream are key technologies in allowing the centrifuge’s operating time to remain as long as possible.
Each piece of the Spinsert system, including pipes, pump and insert, is 100% recyclable and provides a lower environmental impact than stainless-steel models, while reducing the risk of cross-contamination between batches.
During each cycle, the centrifuge rotates at speeds of up to 5,000rpm, with contents experiencing up to 12,000g of force. The short settling distance and large separation area results in industry highs for biomass yields of up to 98% every cycle. Crucially, cell cultures are able to be recovered intact, allowing for later reprocessing if desired.