Biostat® RM TX Bioreactor
Automated, wave-mixed and closed environment suitable for optimal growth of cell products in working volumes up to 5 L.
The Ideal Combination for Your Cells
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.
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.
Learn More about Flexsafe® Technology
* Perfusion bag design protected by patents US 9 017 997 B2 and EP 2 268 788 B1
Conventional harvesting procedures can reduce the number of live cells and affect cell viability. Since cell yield is critical for autologous cell therapies, we have designed our Flexsafe® RM TX bags with a special port for hands-free gravity harvesting. This unique gravity harvesting concept in combination with the Flexsafe® RM TX Harvest Device allows the safe recovery of as many cells as possible by reducing shear stress on these delicate cells and minimizes contamination risks from manual handling.
Our Biostat® B control unit is ideal for walk-away automated analysis and control of perfusion cultures.
Benefit from:
Safety Bellow
Protects operator and tubing from mechanical hazards of moving tray
Temperature Control
Together with the control tower the integrated temperature control is optimized for small working volumes and perfusion membrane bags.
Connectivity to Supervisory Systems
The BioPAT® MFCS multi fermenter control system or third party SCADA system integration (DeltaV™) ensures reliable data management and automation.
Configurable Control Tower
Contains aeration, pumps and temperature control modules for various application needs. The BioPAT® MFCS multi fermenter control system ensures reliable data management and automation.
Load Cells
The integrated precise load cells are ideal for small volume perfusion processes.
12” Touch Screen
Easy-to-use and reliable operation of your Biostat® RM TX system due to intuitive design of human-machine interface and advanced touch-screen technology.
Flexsafe® RM TX Bags
Integrated perfusion membrane; Integrity tested Sartopore® Air vent filters; Industry leading Flexsafe® film; Single-use pH, DO and online biomass sensors.
US
US 6,673,532 B2
US 7,041,493 B2
US 8,304,231 B2
Europe
EP 1 309 719 B1
EP 1 778 828 B1
EP 2 268 788 B1
EP 2 945 978 B1
EP 2 945 801 B1
China
CN104995239B
CN104995029B
Japan
JP6362620B2
Disclaimer: BIOSTAT ® RM TX and Flexsafe® RM TX bags are for research use or further manufacturing use only – not for use in therapeutic or diagnostic procedures. They are not CE marked for in vitro diagnostic use nor are they medical devices. Drug manufacturers and clinicians are responsible for obtaining the appropriate IND | BLA | NDA approvals for clinical applications.
We provide a unique implementation methodology for your bioprocess using SU technologies and hybrid solutions for your type & scale of process.
Sartorius offers comprehensive workflow packages for cell and gene therapy research and manufacturing.
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