Alfa Laval makes ‘full-single-use’ cell harvesting possible amid industry challenges

As growing strain on pharmaceutical technology necessitates more efficient practice, Alfa Laval has launched the CultureOne™, the industry’s first 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 states 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 CultureOne™ 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 the first single-use culture separator that 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.

Ian Forrester, Business Unit Manager for Separation and Food Systems at Alfa Laval, commented on what the CultureOne’s™ launch could mean for the pharmaceuticals industry: “Minimising downtime between cycles while achieving consistently high yields has the potential to revolutionise the pharmaceutical industry. Effective application of the CultureOne™ can greatly accelerate the production of vital proteins, which form a key component of many common vaccines.”

“Hygiene has been propelled back under the spotlight since the pandemic started, particularly within medical environments. However, repeated sterilisation of stainless-steel equipment has a negative impact on overall lab efficiency. Going forwards, single-use, pre-sterilised Spinserts™ will be a key technology in adhering to hygiene standards while allowing the culture harvesting process to remain as productive as possible.”

Alfa Laval is offering a free white paper that explores the intricacies of the CultureOne’s™ robustness and interior design, as well as its unique Hermetic Design and TopStream™ features. The white paper, which also provides key insights on how the centrifuge is able to achieve such consistently high yields and recover cell cultures without damaging protein-producing mechanisms, can be downloaded here.

For more information on the CultureOne™, click here.