According to research from Bioplan Associates, single-use bioprocessing technologies are beginning to dominate the pre-commercial manufacturing space
Alfa Laval has launched the CultureOne, a separator system for single-use cell culture processing.
Many companies have not been able to make the transition to ‘full-single-use’ when harvesting proteins, Alfa says, owing to the lack of a single-use disc-stack centrifuge. The CultureOne system is designed to overcome this challenge and make it easier for biopharmaceutical manufacturers processing smaller capacities.
The company is working to ensure the system’s launch 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.
Plastic systems, placing a new disk stack in the centrifuge bowl each cycle, bypass the need for sterilisation and offer flexibility when producing medicines, Alfa says.
Traditional single-use centrifuges have also been subject to similar limitations on operating time. Though the need for sterilisation is negated, these centrifuges have only been available in batch processing formats, requiring frequent manual ejection of waste material.
The CultureOne is comprised of a portable metal frame that houses 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 system 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.
Each piece of the core centrifuge bowl system, including pipes, pump and insert, is 100% recyclable, while reducing the risk of cross-contamination between batches.
During each cycle, the centrifuge rotates at speeds of up to 5,000 rpm. The short settling distance and large separation area results biomass yields of up to 98% every cycle. Crucially, the company claims, 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, said: “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.”