Step 6: Production
Minimize Time to Patients
Straightforward Scalability and Rational Process Development
The Biostat® STR family is the ideal platform for your single-use production needs, from preclinical supply to commercial production. Classic stirred tank design ensures straightforward scale-up and provides superior mixing and oxygen transfer for high cell density cultures. Our holistic process safety concept based on our Flexsafe® bags, easy installation and pre-use bag testing makes single-use bioreactor operation reliable, safe and easy.
Robust and Easy-to-Use Production Platform
Single use Manufacturing has Never Been Easier
Forget about cell growth issues due to plastic material inconsistencies and toxic leachables derived from antioxidants. Flexsafe® STR bags ensure lot-to -lot consistent growth performance due to control of the resin and additive package, film extrusion and bag manufacturing. Rely on proven and scalable stirred tank design with the BIOSTAT STR® for clinical and commercial manufacturing. First to market, Sartorius provides now also noninvasive and operator independent monitoring of viable biomass with BioPAT® Viamass to support advanced control strategies or just improving batch-to-batch consistency.
Enhance Productivity and Reduce Facility Footprint
Best Single-Use Bioreactor Solution for High-Cell Density, Intensified Cultures
Benefit from the excellent oxygen transfer, mixing and CO2 stripping of our Biostat® STR single-use bioreactors. Easily establish high cell density continuous fed-batch or classical perfusion processes and mitigate the risk of excessive foaming and exhaust filter blockage.
Reduce Risk of Batch Losses
Post-Installation, Pre-Use Leak Testing Takes Safety to the Highest Level
Our validated, automatic and fast method for non-destructive post installation bag testing verifies the intactness of the bag and the manual connections just before use. The pressure drop based technology helps you to detect manual errors or bag defects introduced during unpacking or any other operation after the bioreactor bag has left our facility to eliminate batch losses and keep your production timelines on track.
Publications
Continuous Processing at 2000L Single-Use Bioreactor Scale
Continuous culture provides high space time yields and a constant culture environment, positively affecting product quality. Especially, concentrated fed-batch mode enables single use commercial manufacturing of monoclonal antibodies at 2kL scale; previously only commercially viable in large stainless steel facilities. However, these high cell density cultures are very demanding regarding oxygen transfer and CO2 removal. The BIOSTAT STR® has demonstrated superior performance even for the most challenging processes.
- Continuous Cell Culture Operation at 2000L Scale PDF | 1.3 MB