Step 6: Production
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.
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 to support advanced control strategies or just improving batch-to-batch consistency.
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.
Validate the viral reduction performance of Virosart® HF with our Confidence® Services: Highly purified viruses and expert knowledge.
Rapid and cost-effective single-use / hybrid solutions from early phase development through scale-up to commercial manufacturing.
Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical Biopharmaceuticals
Pressure Decay Method for Postinstallation Single-Use Bioreactor Bag Testing
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.
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