Sartorius Stedim Biotech BIOSTAT STR bioreactors and Flexsafe STR single-use bags

Sartorius Stedim Biotech has launched its next-generation BIOSTAT STR, a fully scalable, single-use bioreactor family based on a conventional stirred-tank design. The bioreactors are an intelligent, low-risk bioprocess development solution for use in multiproduct facilities, as well as contract manufacturing organisations.

The bioreactor series, consisting of five systems in different sizes, offers working volumes from 12.5 to 2000 L. Featuring upgraded hardware and software, as well as fully integrated Flexsafe STR single-use bags, the range ensures 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 bag, which is manufactured from a robust multilayer S80 polyethylene film. The formulation of resins and additives for the film is 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 bioreactor and its bag prevents product cross-contamination, saving time in set-up, validation, clean-in-place procedures and sterilise-in-place operations. Scale-down, linear scale-up and process transfer from 250 mL to 2000 L can be achieved in weeks rather than months.

The system is designed for efficient oxygen transfer, mixing and CO₂ stripping. These features ensure good cell culture performance with reproducible high-density growth of even sensitive cell lines. As a result, the bioreactors are suitable for achieving high cell densities in continuous processes and for safe manufacture of vaccines and recombinant proteins in cGMP environments.

The bioreactor range provides 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.