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