Sartorius Stedim Biotech (SSB) launches its next generation BIOSTAT STR, a fully scalable, single-use bioreactor family based on a conventional stirred-tank design.
Products feature upgraded hardware and software, as well as a fully integrated, new design of Flexsafe STR single-use bags for quick and easy bioprocess scale-up of biologics and vaccines.
The bioreactors are equipped with an improved stainless steel bag holder for user-friendly installation of the single-use Flexsafe STR bag. Five systems in the series vary in size with working volumes ranging from 12.5 L to 2,000 L. Designed with with the same geometries as SSB’s ambr 250 mini bioreactor, scale-down, linear scale-up and process transfer from 250 mL to 2,000 L can be achieved in weeks rather than months.
The newly introduced single-use Flexsafe STR bags with advanced single-use sensor solutions are manufactured from a proprietary, robust multilayer S80 polyethylene film. The formulation of resins and additives for the film are fully characterised, and extrusion process parameters are controlled within established ranges, providing consistent batch-to-batch extractable and leachable profiles. The fully self-contained design of the new bioreactor with its single-use bag prevents product cross-contamination, saving time in set-up, validation, clean-in-place procedures and sterilise-in-place operations.
Besides using bags of the highest purity, the system is designed for efficient oxygen transfer, mixing and CO2 stripping. These combined features are designed to ensure excellent cell culture performance with reproducible high-density growth of even sensitive cell lines. As a result, BIOSTAT STR bioreactors are ideal for achieving very high cell densities in continuous processes and for safe manufacture of vaccines and recombinant proteins in cGMP environments.
The bioreactor range provides greater flexibility in bioprocess control and data acquisition as software connectivity has been upgraded to allow integrated control by either BioPAT MFCS software or commonly used third-party industrial distributed control systems (DCS), such as Emerson DeltaV or Siemens SIMATIC PCS7.
Dr. Thorsten Adams, Director of Product Management for Fermentation Technologies at Sartorius Stedim Biotech, said: “Direct linear scalability is crucial for ensuring the efficiency and cost effectiveness of bioprocess development campaigns. Compared with conventional stainless steel vessels, our next generation BIOSTAT STR bioreactors in combination with the ambr 250 technology will help reduce process development timelines significantly. These highly scalable, single-use bioreactors are an intelligent, low-risk bioprocess development solution for use in multi-product facilities, as well as at contract manufacturing organisations, for the production of biologics and vaccines.”
For more information, contact: www.sartorius.com/biostat-str and www.connect-upstream.com
