Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has introduced 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. Therefore, these increasingly higher concentrations place growing challenges on the purification process. As body feed filtration has proved to be the best solution to solve similar challenges in related industries, Sartorius Stedim Biotech has now developed this robust technology for biotech applications.
Specially designed for cGMP processing, the clarification system consists of prefilled single-use bags containing ultrapure diatomaceous earth (DE) in a choice of 0.5 kg to 10 kg. With a new quick-connect adapter for dust-free powder transfer, DE can be directly mixed into the cell culture fluid. This porous filter aid prevents blockage of the filters. As the system maintains a constant ratio of biomass and filter aid, users will benefit from continuous maximum filter performance.
Consistent results, ease of use, tremendous speed and linear scalability are the key characteristics of the technology. Used in combination with precipitation, this technology transforms harvesting from a two-stage process into a single-stage operation, saving valuable footprint – and time.
Stefan Schlack, the Senior Vice President of Marketing at SSB, comments: “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.”
The ready-to-use clarification system enables harvesting of high cell density cultures up to 2,000 liters.
Sartorius Stedim Biotech, +49.(0)551.308.3324, www.sartorius.com
