Wave-mixed bioreactor for shear-sensitive cell cultures

Optimize cell cultivation with a modular, wave-induced mixing system, designed for seamless scaling and precise process control, ensuring conditions ideal for sensitive therapies like CAR-T and stem cell treatments.

Cultivates and Scales Up Cell Therapies

The Biostat® RM from Sartorius is a GMP-compliant, wave-mixed bioreactor that solves key challenges in cell therapy production. This system employs a rocking motion to create an optimal environment for shear-stress-sensitive cell lines, crucial for high-quality yields in products like CAR-T cells and monoclonal antibodies. Ideal for biopharmaceuticals, vaccines, mAbs, and gene therapies, the Biostat® RM integrates seamlessly into your production line with its flexible single-use design.

With a working volume up to 200 liters, it supports scale-up from process development to commercial manufacturing, reducing time and costs associated with expanding production capabilities. Powered by the Biobrain® automation platform, this bioreactor allows for advanced process control with integrated BioPAT® sensors, ensuring consistent operational parameters across all production stages.

Its single-use design minimizes contamination risks and simplifies cleaning processes, while the modular architecture offers configurability to suit varied production scenarios, thus enhancing process intensification. The Biostat® RM meets rigorous industry standards, making it suitable for stringent environments in pharmaceutical and biotech manufacturing.

Benefits

  • Enhances cell growth with optimal wave-mixing motion, particularly crucial for shear-sensitive lines.
  • Reduces contamination risks with single-use Flexsafe® RM bags, streamlining the validation process.
  • Facilitates seamless scale-up from development to manufacturing, saving time and resources.
  • Integrates advanced process control through Biobrain® automation, ensuring precise and reliable operations.
  • Complies with GMP standards, supporting rigorous pharmaceutical manufacturing environments.

General


Applications
Vaccines,Cell therapy,Regenerative medicine,Biopharmaceuticals,Monoclonal antibodies (mabs),Gene therapy
End products
Car-t cell therapies,Allogeneic cell therapies,Autologous cell therapies,Stem cell therapies,Bispecific antibodies,Mrna vaccines,Viral vector-based gene therapies,Influenza vaccines,Monoclonal antibody drugs
Steps before
Media Preparation,Cell Culture Expansion,Inoculation,Seed Train Preparation,Process Development
Steps after
Harvesting,Purification,Analytical Testing,Storage,Bioprocess Scale-up
Input ingredients
CHO cell lines,HEK293 cells,stem cells,CAR-T cells,culture media,flexsafe RM bag,glucose,lactate
Output ingredients
cell cultures,monoclonal antibodies,proteins,viruses,bioconjugates,regenerative medicine products
Market info
Sartorius AG is renowned for manufacturing high-precision laboratory and bioprocess equipment. They specialize in filtration, fermentation, and cell cultivation systems, known for their innovation and reliability in the pharmaceutical and biotech industries.

Technical Specifications


Bioreactor Type
Wave-mixed,rocking motion
Automation
Biobrain® platform
Working Volume
1 L to 100 L
Capacity
2 L to 200 L
Compliance
GMP compliant
Sensor Type
pH,DO,viable biomass,glucose and lactate
Bag Type
Flexsafe®RM
Tray Size
20 L,50 L,200 L
Environmental Conditions
Control of pressure,temperature,gassing,rocking angle
Process Intensification
Seed Train Intensification (N-1 Perfusion),High Cell Density Cell Banking
Single-Use Technology
Flexsafe®RM bags

Operating Characteristics


Working Mechanism
Rocking motion,wave-mixed
Automation Level
Biobrain® automation platform
CIP/SIP Capability
Not applicable (single-use bags)
Batch vs Continuous Operation
Batch
Scalability
2L to 200L
Flexibility
Modular rocker platforms
Process Control
Uses BioPAT® sensors
Parameter Definition
Advanced with BioPAT® sensors
Cleaning Method
Single-use,disposable bags

Material Compatibility


Biological compatibility
Compatible with multiple cell lines including CHO,HEK293,stem cells,CAR-T cells
Cleanability
Sterile cultivation chamber with integrated control measurements
Corrosive resistance (e.g. acids)
Not Applicable
Density/particle size
Not Applicable

Product type Characteristics


Cell Type Compatibility
CHO,HEK293,Stem Cells,CAR-T Cells
Disposable Bag Type
Basic,Optical,Perfusion

Physical Characteristics


Machine footprint
Compact,space-saving design
Rocker size
20 L,50 L,or 200 L platform
Bag size (Total Volume)
1 L,2 L,10 L,20 L,50 L,100 L,200 L
Tray size
20 L or 50 L tray
Control panel type
Biobrain® automation platform
Working volume range
100 ml to 100 L
Discharge method
Single-use Flexsafe®RM bags

Custom Options


Control panel type
Biobrain® automation platform
Integration possibilities
Native connectivity to BioPAT®MFCS4,SCADA,DCS
Modular design
Rocker platforms for 20 L,50 L,and 200 L configurations
Single-use sensor integration
pH,DO,glucose,lactate,BioPAT®Viamass
Bag configuration options
Basic,Optical,Perfusion configurations
Automation level
Flexible process setup with Biobrain®
Tray size options
20 L,50 L,200 L
System scalability
2 L to 200 L with only two rocker platforms