Bioreactor

Orbital shaken benchtop bioreactor for single-use bags
The SB10-X is an orbital shaken benchtop bioreactor system for the cultivation of human, mammalian and plant cells in a single-use bag. It consists of six modules (excluding the bag) and has a working volume from 4 litres up to 12 litres. The SB10-X can be used in research, process development or as a pilot scale bioreactor.

Performance characteristics

• Cultivation of human, mammalian and plant cells

• Fast, simple set up

• Easy scale-up

• Online measurement and control of pH and DO

• Three different types of single-use bags available
Single-use bag for a fast and simple set up
The cylindrical vessel accepts a single-use 3D bag. This bag requires no additional mixing device, enables quick set up times and eliminates elaborate cleaning and sterilising procedures. Various ports are incorporated to allow feeding, inoculation, harvesting and sampling. The standard bag has built-in optical sensors for pH/DO allowing online measurement and control of pH and DO in the medium. Two other bag types are available: a basic single-use bag with no optical sensors and a perfusion bag for ATF and TFF perfusion.

• Orbital motion
The orbital motion of the SB10-X ensures efficient liquid mixing. It facilitates high oxygen transfer rates with low shear forces. Mechanical stress on the cells is reduced thanks to bubble-free surface gassing with almost no frothing. This motion is particularly suitable for microcarrier cultivation. The SB10-X uses the unique Kuhner direct drive which is very robust and provides accurate control of the orbital speed.

• Trouble free scale-up
The SB10-X fills a gap in the scale-up chain from commonly used single-use flasks all the way up to 50 L and 200 L bioreactors. The consistent hydrodynamics of shaken bioreactors provide reproducible cultivation conditions throughout the volume range. The culture from the SB10-X can serve as a preculture for the SB50-X and SB200-X. The SB10-X can also be used as a pilot scale bioreactor.

• Heating and online pH & DO measurement
The tray module, which is fixed onto the ES-X shaker module, contains integrated heating and the connections for online pH and DO measurement.

•Vessel module
Special emphasis has been placed on developing a user-friendly vessel module. The vessel together with its bag can be easily detached by the user and carried to the clean bench.

• Filter heater
A filter heater for one exhaust filter is placed above the vessel module. The magnetic mounting makes handling the filter heater very simple and allows its location in various places. The filter heater combats water vapour condensation in the outlet air preventing blockages in the membrane.

• Control unit and software
The compact and functional design of the control unit provides easy handling and monitoring of the bioprocess parameters. The control unit has an integrated and adjustable 12” touch screen with USB and Ethernet connections. The Kuhner Insight application software for data recording, calibration, programming and controlling is user-friendly and 21 CFR Part 11 compliant. Control of pH/DO, medium temperature, shaking frequency and gas flow rate and mixture is possible.

• Pumping system
The control unit incorporates three peristaltic pumps which allow aseptic fluid management. This enables simple regulation of the pH-value, feeding and the transfer of the culture media (scale-up or processing).

• Gas mixing (FlowCon)
The SB10-X control unit has an integrated gas mixing device (FlowCon).
Whether stabilizing the pH with CO2, or preventing low dissolved oxygen concentrations, the gas mixer meets all user needs. Four mass flow controllers (N2, O2, CO2 and air or gas mixture) ensure highly accurate and reproducible gas mixing. An integrated pressure sensor prevents over pressure in the bioreactor. Step limits can be freely programmed by the user. Integrated air filters and back pressure valves ensure interference free and long operating times for the FlowCon.

Detailed technical data can be found in the product catalog.

Orbital shaken bioreactor for single-use bags

The SB50-X is an orbital shaken bioreactor for the cultivation of human, mammalian and plant cells in a single-use bag. A working volume from 15 litres up to 50 litres for the SB50-X ensures easy scale-up from microtiter plates to shaking flasks and all the way up to 200 litres. The SB50-X can be used in research, process development or production.
The SB50-X was developed and tested in collaboration with ExcellGene SA (Monthey, Switzerland) and the Swiss Federal Institutes of Technology EPFL (Lausanne, Switzerland).

Performance characteristics

• Large capacity (50L working volume)

• Single use bioreactor system

• Cultivation of human, mammalian and plant cells

• Fast, simple set up

• Easy scale-up

• Online measurement of pH and DO

Single-use bag for fast and simple set up
The cylindrical vessel accepts a single-use bag. This bag requires no additional mixing device, enables quick set up times and eliminates elaborate cleaning and sterilising procedures. Various ports are incorporated to allow feeding, inoculation, harvesting and sampling. The bag has built in optical sensors for pH and DO.

Orbital motion
The orbital motion of the SB50-X ensures efficient liquid mixing. It allows high oxygen transfer rates with low shear forces. Mechanical stress on the cells is reduced thanks to bubble-free surface gassing with almost no frothing. This motion is particularly suitable for microcarrier cultivation. The SB50-X uses the unique Kuhner direct drive which provides accurate control of the orbital speed.

Trouble free scale-up
The SB50-X fills a gap in the scale-up chain from microtiter plates all the way up to 200 litres. The consistent hydro-dynamics of shaken bioreactors provide reproducible cultivation conditions throughout the volume range. The culture from the SB50-X can also serve as preculture or inoculum for the SB200-X.

Control unit and online measurement
The bespoke control unit, designed by Kuhner, uses the latest touch-screen technology and Kuhner Insight software for data recording, calibration, programming and controlling. Technical controls for 21 CFR Part 11 compliance are built into the software.
The SB50-X can be heated or cooled. Temperature ramps are easily programmed and processed.
Online measurement of each parameter (dissolved oxygen and pH-value in the medium) is available.

Pumping system
The control unit incorporates two small and one big peristaltic pump. This enables simple regulation of the pH value, feeding and the transfer of the culture media (scale-up or processing).

Gas mixing
The SB50-X has an integrated gas mixing device (FlowCon).
Whether stabilizing the pH with CO2, or preventing low dissolved oxygen concentrations, the gas mixer meets all user needs. Four mass flow controllers ensure highly accurate and reproducible gas mixing. An integrated pressure sensor prevents over pressure in the bioreactor by reducing the gas flow in the first step (1. limit) and shutting off the gas flow in the second step (2. limit). Step limits can be freely programmed by the user. Integrated air filters and back pressure valves ensure interference free and long operating times for the FlowCon.

Filter heater
A height adjustable filter heater, with up to two exhaust filters, is installed above the cylindrical vessel. Special emphasis has been placed on developing a user friendly unit. The filter heater combats any water vapour condensation in the outlet air which might cause the membranes to block. The temperature is monitored and controlled by Kuhner Insight software.

Detailed technical data can be found in the product catalog.

Orbital shaken bioreactor for single-use bags
The SB200-X is an orbital shaken bioreactor for the cultivation of human, mammalian and plant cells in a single-use bag. A working volume from 50 litres up to 200 litres for the SB200-X ensures easy scale-up from microtiter plates to shaking ­ asks and all the way up to 200 litres. This user friendly system can be easily deployed in research, process development or production.
The SB200-X was developed and tested in collaboration with ExcellGene SA (Monthey, Switzerland) and the Swiss Federal Institutes of Technology EPFL (Lausanne, Switzerland).

Performance characteristics

• Large capacity (200L working volume) single use bioreactor system

• Cultivation of human, mammalian and plant cells

• Fast, simple set up

• Easy scale-up

• Online measurement of pH and DO

Single-use bag for a fast and simple set up
The vessel accepts a single-use bag. This bag requires no additional mixing device, enables quick set up times and eliminates elaborate cleaning and sterilising procedures. Various ports are incorporated to allow feeding, inoculation, harvesting and sampling. The bag has built in optical sensors for pH and DO.

Orbital motion
The orbital motion of the SB200-X ensures efficient liquid mixing. It allows high oxygen transfer rates with low shear forces. Mechanical stress on the cells is reduced thanks to bubble-free surface gassing with almost no frothing. This motion is particularly suitable for microcarrier cultivation. The SB200-X uses the unique Kuhner direct drive which provides acurate control of the orbital speed.

Trouble free scale-up
Another advantage of the SB200-X is easy scale-up from microtiter plates all the way up to 200 litres. The consistent hydro-dynamics of shaken bioreactors provide reproducible cultivation conditions throughout the volume range.

Control unit and online measurement
The bespoke control unit, designed by Kuhner, uses the latest touch-screen technology and Kuhner Insight software for data recording, calibration, programming and controlling. Technical controls for 21 CFR Part 11 compliance are built into the software.
The SB200-X can be heated or cooled. Temperature ramps are easily programmed and processed.
Duplex online measurement of each parameter (dissolved oxygen and pH value) is available ensuring greater process safety.

Pumping system
The control unit incorporates two small and one big peristaltic pump. This enables simple regulation of the pH value, feeding and the transfer of the culture media (scale-up or processing).

Gas mixing
The SB200-X has an integrated gas mixing device (FlowCon).
Whether stabilizing the pH with CO2, or preventing low dissolved oxygen concentrations, the gas mixer meets all user needs. Four mass flow controllers ensure highly accurate and reproducible gas mixing. An integrated pressure sensor prevents over pressure in the bioreactor by reducing the gas flow in the first step (1. limit) and shutting off the gas flow in the second step (2. limit). Step limits can be freely programmed by the user. Integrated air filters and back pressure valves ensure interference free and long operating times for the FlowCon.

Filter heater
A height adjustable filter heater, with up to two exhaust filters, is installed above the vessel. Special emphasis has been placed on developing a user friendly unit. The filter heater combats any water vapour condensation in the outlet air which might cause the membranes to block. The temperature is monitored and controlled by Kuhner Insight software.

Detailed technical data can be found in the product catalog.

Orbital shaken bioreactor for single-use bags with a working volume up to 2500 litres
The next generation of manufacturing-scale orbital shaken bioreactor (OSB) SB2500-Z is now available for the cultivation of human, mammalian, plant, and insect cells in a single-use bag. The bioreactor system has a working volume of 500 to 2500 liters. This user-friendly system has comparatively short set-up times and can be easily deployed in production. The SB2500-Z complies with GMP requirements and regulations.

Performance characteristics

• Large range of working volume: 500-2500 L

• Cultivation of human, mammalian, plant, and insect cells

• User-friendly & fast and simple set-up

• 3D single-use bag

• Trouble-free scale-up

• Online measurement and control of pH and DO

• Qualification for GMP production processes

Single-use bag for a fast and simple set up
The gamma irradiated 3D single-use bag for the Kühner orbital shaken bioreactor requires no additional mixing device and is therefore light and easy to handle. This enables quick set up times and eliminates elaborate cleaning and sterilizing procedures. The single-use bag has a working volume from 500 liters up to 2500 liters. Various ports are incorporated to allow inoculation, feeding, sampling, pH regulation, and harvesting. Two optical sensors each for pH and for DO measurement are built in. Customized bags are easily available on request.

Orbital motion
The orbital motion of the SB2500-Z ensures efficient liquid mixing with low localized power input per unit volume. It allows high oxygen transfer rates with low shear forces. Mechanical stress on the cells is reduced thanks to bubble-free surface gassing with almost no frothing.

Trouble free scale-up
Another advantage of the SB2500-Z is the easy scale-up from microtiter plates over shake flasks to shaken bioreactors all the way up to 2500 liters. The consistent hydro-dynamics of shaken bioreactors provide reproducible cultivation conditions throughout the scaling process.

Good Manufacturing Practice (GMP) and IQ/OQ Documentation
The SB2500-Z complies with GMP requirements and regulations. Kuhner products have established a global reputation of excellence under GMP requirements. Documentation, development and production along with the full life cycle of our products are continuously enhanced to match the requirements of 21 CFR and GAMP 5.
IQ-OQ (Installation Qualification and Operation Qualification), an equipment qualification required for GMP procedures, is available from Kuhner and qualification services can also be provided at the customer's premises.
We subject all our shaking machines to an elaborate final test before delivery and send the test protocols to our customers.

Reliable and monitored drive system
The shaking unit of the SB2500-Z uses a robust and long-lasting drive system which guarantees accurate control of the orbital speed and low energy consumption. The drive system (agitation) requires zero bag penetrations and runs without belts, meaning no abrasion or particle generation, an important factor for production processes in cleanrooms. Motor-specific parameters are constantly monitored, allowing for predictive maintenance and failure prevention. The entire drive unit may be exchanged with a process in place in less than 2 hours.

Control unit
The bespoke control unit, designed by Kuhner, uses the latest touch-screen technology and Siemens SCADA for data recording, calibration, programming and controlling. Technical controls for 21 CFR Part 11 compliance are built into the software.

Temperature regulation
The SB2500-Z can be electrically heated or (optionally) cooled. If cooling is chosen as an option, a cooling ring is embedded in the base plate of the SB2500-Z. Cooling is achieved by connecting an external cooling device. An integrated valve, controlled by the software, regulates the set point temperature. Temperature ramps are easily programmed and processed.

Online measurement and control of pH and DO (dissolved oxygen)
The single use bag has built in pre-calibrated, optical sensors for pH and DO (two of each). The duplex online measurement of both parameters in the medium ensures greater process safety. The pH value can be controlled by the addition of acid/base via peristaltic pumps or stabilized via dosage of CO2. To control the DO, the gas flow of the inlet gas can be increased or decreased, the percentage of oxygen in the inlet gas can be varied (via the gas mixing device), and the shaker speed can be adjusted.

Pumping system
There are three peristaltic pumps, which can be placed external, mobile and can be controlled by the bioreactor software. The control unit incorporates two smaller and one large peristaltic pump. This enables simple regulation of the pH value, feeding and the transfer of the culture media for downstream processing.

Gas mixing (FlowCon)
The SB2500-Z has an integrated gas mixing device (FlowCon). Whether stabilizing the pH with CO2, or preventing low dissolved oxygen concentrations, the gas mixer meets all user needs. Four mass flow controllers ensure highly accurate and reproducible gas mixing. An integrated pressure sensor prevents over pressure in the bioreactor by reducing the gas flow in the first step and shutting off the gas flow in the second step. Step limits can be freely programmed by the user. There is also another pressure sensor directly connected to the bag via the filter. Integrated gas filters ensure interference free and long operating times for the FlowCon.

Filter heater
A height adjustable filter heater, with up to two exhaust filters, is installed above the vessel. Special emphasis has been placed on developing a user-friendly unit. The filter heater combats any water vapor condensation in the outlet air which might cause the membranes to block. The temperature is monitored and controlled by the Siemens SCADA software of the control unit.