The Biostat® RM TX system consists of an automated control unit and a rocking platform, for gently agitating a single-use Flexsafe® RM bag. Enabling the ex vivo expansion of patient-specific T cells or other types of immune cells, the Biostat® RM TX is suitable for process development, as well as for the expansion of relevant cell numbers. Fed-batch, perfusion processes or a combination of culture modes are all possible with this system.
Regenerative Medicine therapeutics repair, replace and engineer human cells, tissues and organs to restore their normal function. The discipline has great potential to address clinical needs that are currently unmet by conventional pharma or biopharmaceutical products. Rocking motion bioreactors are widely used for the expansion step during stem and T-cell cultivation processes, incl. CAR-T. Companies are actively approaching us to work on the integration of our rocking motion bioreactors into their process environment and explore the PAT capabilities coming with our single-use systems. Tests that these customers perform with Flexsafe® RM bags continue to be successful, even for the most sensitive cells.
The Right Solution for Your Needs
At Sartorius, we help you develop a scalable, cost-effective process and combine this with the security of our worldwide supply chain and manufacturing capabilities. Our expertise and experience allow us to support early stage process development and establish scalable processes.
The complete control of our raw materials, the extrusion process and the bag assembly, provides lot-to-lot product consistency.
In collaboration with our resin and film suppliers, we have optimized the resin and minimized the additives in our Flexsafe® film technology ensuring excellent, reproducible batch-to-batch culture performance of even the most sensitive cells.