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The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.
Sartorius Stedim Biotech, a supplier for the biopharmaceutical industry, has launched Sartoclear Dynamics, a clarification system featuring new single-use technology for harvesting mammalian cell cultures with high cell densities.
Continuous improvements in growth media and cell lines have elevated biomass concentrations in bioprocesses. The increasingly higher concentrations pose challenges in the purification process. Body feed filtration is a recognized solution for solving similar challenges in other related industries. Sartoclear Dynamics is a robust technology developed by Sartorius for biotech applications. It is specially designed for cGMP processing. Sartoclear Dynamics consists of prefilled single-use bags containing ultrapure diatomaceous earth in a choice of 0.5 kg to 10 kg.
With a new quick-connect adapter for dust-free powder transfer, diatomaceous earth can be directly mixed into the cell culture fluid. This porous filter aid prevents blockage of the Sartoclear Dynamics filters. The system maintains a constant ratio of biomass and filter aid, allowing users to benefit from continuous maximum filter performance.
According to Sartorius, this new technology gives consistent results, is easy to use, has tremendous speed, and linear scalability. Used in combination with precipitation, this technology transforms harvesting from a two-stage process into a single-stage operation, saving valuable footprint and time.
“With Sartoclear Dynamics, we are closing one of the biggest gaps in the single-use product offering. Nowadays, 2,000 L is a standard size for single-use bioreactors, but a centrifuge is still required for removing cells from such volumes. This technology now enables a fully single-use process, which brings enormous flexibility to our customers’ facilities. It also eliminates considerable capital investments, which is attractive for newcomers from emerging biotech markets,” Stefan Schlack, senior vice president of marketing of the company, commented in a press release.