The future of bioprocessing: closed single-use batch harvest system

Single-use or disposable bioprocessing equipment is now used for at least 85% of pre-commercial scale (i.e., preclinical and clinical, biopharmaceutical manufacturing) and is increasingly being adopted for commercial products manufacturing. — American Pharmaceutical Review, 2018

Single-use systems have brought about a revolution in an already-revolutionary field of work. You probably can look around your own workspace to understand why; the benefits of single use are obvious across pharmaceutical applications.

Single use allows greater flexibility and scalability. Specially-designed factories that, by necessity, once were monoliths on the urban horizon are now sized down for mobility and economy, allowing companies and researchers to go where the work is most needed with minimal disruption and ramp-up.

In some cases, dedicated factory setups can even be avoided altogether, with “normal” buildings substituting an appropriate work environment, allowing bioprocessing work to be done almost anywhere.

But it goes beyond the physical space a lab occupies. Changes in ownership, process or product — once vexing, time-consuming and expensive endeavors — can be managed with minimal complexity. The extensive cleaning and decontamination process for working with vaccines, for example, has been rendered mostly unnecessary, and validation for current Good Manufacturing Practice standards is built directly into the single-use system. Also, today’s accelerated approval processes demand small-batch work at high speeds, and time lost to setup and cleanup is irreplaceable and costly.

Resource cost savings are another benefit: the efficiency of cleaning means less water use, lower utility bills and a reduced need for chemicals.

There is no question that the advent of single use in pharmaceutical bioprocessing has changed how we work and supported breakthroughs undreamed of even a decade ago.

Not all parts of BioProcess have been available as single used options so far though. Specifically, at the start of the downstream process, where centrifugation plays, there was a gap in availability of products to match the single use – and more so the closed single use harvest needs.

Traditional open systems expose manufactured materials to the lab environment, increasing the risk of contamination. Migrating to a sterilized closed system reduces the risk of contamination and ensures a consistent, low-risk environment for your cell cultures throughout the workflow.

Thermo Fisher Scientific’s CentriPAK BioProcess Container (BPC) system enables biopharma researchers to fully reap the benefits of a closed system for centrifugation while producing up to 300 l high-volume batches with gentle centrifugation.

To be ready for the next revolution in bioprocessing, today’s researchers need to fully explore the current options for single-use, sterilized, closed systems in their labs production. The flexibility, efficiency and security — all benefits of single use for centrifugation — are accessible today through Thermo Fisher Scientific’s CentriPAK BPC system.

Be ready for the next revolution in bioprocessing. Explore the Thermo Fisher Scientific Centrifuges for Bioprocessing.