Sartorius Stedim Biotech (SSB), has launched its next generation BIOSTAT STR, a fully scalable, single-use bioreactor family based on a conventional stirred-tank design. This new bioreactor range features upgraded hardware and software, as well as an integrated, new design of Flexsafe STR single-use bags, designed to help ensure quick and easy bioprocess scale-up of biologics and vaccines. 
 
The BIOSTAT STR bioreactors are equipped with an improved stainless steel bag holder designed for user-friendly installation of the single-use Flexsafe STR bag. The bioreactor series consists of five systems in different sizes and offers working volumes from 12.5 L to 2,000 L. According to the company, because the bioreactors are designed with the same geometries as SSB’s ambr 250 mini bioreactor for scale-down, linear scale-up and process transfer from 250 mL to 2,000 L can be achieved in weeks using this technology platform. 
 
The Flexsafe STR bags with single-use sensor solutions are manufactured from a robust multilayer S80 polyethylene film. The formulation of resins and additives for the film are fully characterized, and extrusion process parameters are controlled within established ranges. According to the company, this provides consistent batch-to-batch extractable and leachable profiles. The self-contained design of the new bioreactor with its single-use bag prevents product cross-contamination, to help save time in set-up, validation, clean-in-place procedures and sterilize-in-place operations. 
 
BIOSTAT STR bioreactors are designed to achieve very high cell densities in continuous processes and for safe manufacture of vaccines and recombinant proteins in cGMP environments. 
 
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 organizations, for the production of biologics and vaccines.”