New generation of bioreactors combined with new Flexsafe STR bags offer a fully scalable, single-use system¬†¬†
Sartorius Stedim Biotech (SSB), a¬†leading international supplier to the biopharmaceutical industry, announces the launch of its¬†next generation BIOSTAT STR, a fully scalable, single-use bioreactor family based on a¬†conventional stirred-tank design.
This new bioreactor range featuring upgraded hardware and¬†software, as well as a fully integrated, new design of Flexsafe STR single-use bags, ensures quick¬†and easy bioprocess scale-up of biologics and vaccines.¬†
The BIOSTAT STR bioreactors are equipped with an improved stainless steel bag holder for user-friendly¬†installation of the single-use Flexsafe STR bag.
The bioreactor series consisting of five¬†systems in different sizes offers working volumes from 12.5‚Äď2000L.
Because the bioreactors¬†are designed with the same geometries as SSB‚Äôs ambr 250 mini bioreactor, the industry gold¬†standard for scale-down, linear scale-up and process transfer from 250mL to 2000L can be¬†achieved in weeks rather than months using this innovative technology platform.¬†
The new bioreactors and the newly introduced single-use Flexsafe STR bags are a perfect match.¬†
The 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 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 new 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, stated: ‚ÄúDirect linear scalability is crucial for ensuring the efficiency and costeffectiveness¬†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¬†multiproduct facilities, as well as at contract manufacturing organisations, for the production¬†of biologics and vaccines.‚ÄĚ