Large-scale bioreactor for cell therapy manufacturing
Tackle the challenge of scaling therapeutic cell production with a high-capacity bioreactor designed for efficient large-scale manufacturing and precise process control, ensuring the quality and integrity of sensitive cell cultures.
Cultivates and Expands Therapeutic Cells at Scale
The PBS-80 Vertical-Wheel Bioreactor from PBS Biotech is engineered for large-scale manufacturing of therapeutic cells. It uses a unique vertical-wheel design that optimizes hydrodynamic conditions for anchorage-dependent human cells, such as cell aggregates and cells grown on microcarriers. With an 80-liter working volume, it meets the demands of both clinical stage production and commercial scale manufacturing. This bioreactor integrates seamlessly into your processing line, featuring an adjustable height harvest valve for efficient medium exchange and harvesting. Equipped with a touchscreen interface, it allows for intuitive customization and real-time process monitoring, including remote control capabilities. The PBS-80 supports advanced automation and ensures compliance with 21 CFR Part 11 cGMP standards. Available with single-use or reusable sensors, it offers flexibility in operation while being easy to clean and maintain. With PBS Biotech’s engineering support, you can tailor this bioreactor to meet specific production needs, making it ideal for producing CAR-T cell therapies, NK cell therapies, and other stem cell products.
Benefits
- Enhances production efficiency by enabling large-scale expansion of therapeutic cell cultures.
- Minimizes manual intervention with automated process customization and remote monitoring.
- Reduces cell loss and operational disruption with rapid medium exchange via adjustable height harvest valve.
- Ensures regulatory compliance with 21 CFR Part 11 cGMP standards.
- Provides versatility for diverse cell culture applications with configurations for both single-use and reusable sensors.
- Applications
- Cell therapy products,Msc manufacturing,Hipsc aggregates,Therapeutic cells,Cell aggregates,Clinical stage production,Commercial scale manufacturing,Anchorage-dependent human cells,Cells on microcarriers
- End products
- Car-t cell therapies,Nk cell therapies,Stem cell products,Large-scale cell aggregate products,Human ipsc-derived therapies,Mesenchymal stem cell therapies,Microcarrier-based cell culture products
- Steps before
- Process Development,Clinical Trials
- Steps after
- Medium Exchange,Harvesting,Data Storage,Data Access
- Input ingredients
- therapeutic cells,cell culture media,anchorage-dependent human cells,single-use sensors,dissolved oxygen,pH balance,cell aggregates,microcarriers
- Output ingredients
- expanded therapeutic cells,cell therapy products,spent cell culture media,data on process parameters
- Market info
- PBS Biotech is known for manufacturing single-use, scalable bioreactor systems designed for cell therapy and biologics production, featuring their innovative Air-Wheel mixing technology for efficient and consistent results.
- Working Volume
- 80L
- Touchscreen Interface
- Yes
- Adjustable Height Harvest Valve (AHHV)
- Yes
- Dissolved Oxygen Sensor Compatibility
- Single-use / Reusable
- PH Sensor Compatibility
- Single-use / Reusable
- Remote Process Monitoring
- Yes
- Process Data Storage
- Complies with 21 CFR Part 11
- Automation level
- Touchscreen interface
- Batch vs. continuous operation
- Batch
- Cell culture compatibility
- Anchorage-dependent human cells
- Scale-up capability
- 80L working volume
- Sensor type flexibility
- Single-use or reusable DO and pH sensors
- Remote monitoring
- Yes
- Data storage compliance
- 21 CFR Part 11 cGMP
- Height adjustment mechanism
- Adjustable Height Harvest Valve
- Installation qualification
- Protocols available
- Operation qualification
- Protocols available
- Biological compatibility
- Compatible with therapeutic cells
- Cleanability
- Designed for easy cleaning in bioprocess environments
- Corrosive resistance (e.g. acids)
- Suitable for bioprocess chemicals
- Density/particle size
- Optimized for cell aggregates and microcarriers
- Culture applications
- Anchorage-dependent human cells / Cell aggregates
- GMP Compliance
- Yes
- 21 CFR Part 11
- Yes
- CGMP Compliance
- Yes
- Footprint
- Floor-mounted with wheels
- Bioreactor size
- 80L working volume
- Harvest valve
- Adjustable Height Harvest Valve (AHHV)
- Impeller type
- Vertical-Wheel
- Single-use vessel option
- Floored or floorless
- Control Panel Type
- Touchscreen interface
- Integration Possibilities
- Remote monitoring and control
- Process Customization
- Intuitive process customization and control
- Sensor Configurations
- Single-use or reusable DO and pH sensors
- Data Compliance
- 21 CFR Part 11 cGMP Upgrade
- Harvest Mechanism
- Adjustable Height Harvest Valve (AHHV)