Unique agitation improves cell culture performance
The XRS 20 Bioreactor System is a new single-use bioreactor system with unique agitation and control properties designed for the cultivation of mammalian cells in suspension culture under controlled conditions and suitable for applications ranging from general life sciences research to seed train operations and full GMP production at the 2 to 20 liter scale.|
Comprised of three components (XRS 20 Platform, XRS 20 Controller, and Allegro™ XRS 20 Biocontainers), the XRS System produces superior performance (as measured by higher density, better cell viability, and higher expression levels) compared to competitor rocker systems because its unique Bi-Axial agitation produces shorter mixing times and higher mass transfer properties. The XRS 20 Bioreactor System incorporates a number of other features to ensure easy operation, robust performance, and suitability for GMP operations: |
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| 特点 | 优势 |
| XRS 20 Platform | |
| Bi-axial agitation (rocking motion on two horizontal axes at 90 degrees separation) | Improved agitation properties:shorter mixing times and higher mass transfer rates |
| Fully enclosed platform with safety interlock | Improved operator safety, suitable for production environments, protects light sensitive culture media |
| Allegro XRS 20 Biocontainer | |
| 3 dimensional biocontainer design | Superior mixing (with bi-axial platform), robust in operation |
| Biocontainer with integrated optical sensors, integrated filters, pre-assembled tubing sets | True single use system, ease of installation, minimal turn-around time |
| Gas inlet and exhaust filters are integrity testable, sterilizing grade 0.2 μm | Improved suitability for GMP operations |
| Integrated bottom drain with rotary lift valve | Improved suitability for GMP operations, minimal hold up volume, ease of use |
Multiple liquid addition ports:
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Improved ease of use, easily handles fed batch operations, acid/base pH control feeds |
| Integrated single use pH and Dissolved Oxygen (DO) sensors | Ease of use and reduced probability of contamination |
| Integrated sampling port | Ease of use - Very low hold up volume (less than 5 mL), capable of sampling without stopping agitation |
| Single-use biocontainer built with Allegro film | Assurance of robustness, quality and supply, track record of use of film in GMP operations, validation guide available |
| FeatureBenefits | |
| Advanced, full function, small footprint controller with touchscreen interface | Easy to use, but with powerful control capabilities (below).Touchscreen simplifies setup, calibration, operation, alarms, trending and process data collection |
| 3 thermal mass flow gas controllers | Accurate 3 gas mixing and flow control, programmable |
| Full function control software |
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| Integrated USB ports | Rapid, easy data collection and software updates |
| Convenient access to utility connections | Quick set up and easy maintenance |
| In-line container pressure monitor with relief valve | System robustness – prevents over pressuring of biocontainer |
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| Tubing management system | In-process sampling | Drain and optical sensors |
XRS 20 Bioreactor System Specifications
| Allegro XRS 20 Biocontainer | Minimum Working Volume | 2 L |
| Maximum Working Volume | 20 L | |
| Irradiated | Gamma:dose 25-40 Kgray | |
| 控制员 | Control Station | Controls up to 32 control loops; stores 10 recipes and 8 process variables for trend graphing.Includes an industrial touchscreen monitor/user interface, 3 built-in pumps & connectors for all utilities & communications signals. |
| Touchscreen Interface/Display | 25.4 cm (10 in.)LED monitor | |
| Temperature | Indication | Digital display in 0.1 °C increments |
| Range | From 8 °C above ambient temperature to 40 °C (ambient temperature defined as 10 to 30 °C) | |
| 控制 | P&I control for heating.Heating is assured via the heater mat and cooling via ambient temperature. | |
| Sensor | Platinum RTD probe | |
| Agitation | Drive | Stepper motors |
| Indication | Digital display in 1 rpm increments. | |
| Range | 1 - 35 rpm | |
| Angle | -15° to +15° in both X and Y directions | |
| 控制 | Stepper motor controlled | |
| Exhaust | 过滤器 | 0.2 μm disposable filter (integrated with biocontainer) |
| Exhaust Heater | Silicone heater mat | |
| Aeration | 3-Gas System | Up to 3 gases (Air, O2, CO2, or Mixture), Thermal Mass Flow Control |
| Sparger | Gas sparged into biocontainer headspace | |
| Inlet Filter | 0.2μm disposable filter (integrated with biocontainer) | |
| pH | Indication | Digital display in 0.01 pH increments |
| Range | 6 - 8 pH | |
| 控制 | P&I | |
| Sensor | Non-invasive optical pH probe | |
| DO | Indication | Digital display in 0.1% increments |
| Range | 0 - 200% | |
| 控制 | 3-gas P&I control | |
| Sensor | Non-invasive optical DO probe | |
| 泵 | Pump 1 |
Assignable peristaltic pump Fixed speed (14 rpm) or variable duty cycle Available control modes:Off, On, Prime. |
| Pumps 2 & 3 |
Assignable peristaltic pumps Fixed speed (109 rpm) or variable duty cycle Available control modes:Off, On, Prime. |
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| 公用设施 | 气体 | 68.9 mbar (1 PSIG) maximum |
| Electrical Requirements | Control Station | 100-240 VAC, 50/60 Hertz, Single phase, 13 amp |
| Reactor Platform | 105-230 VAC, 50-60 Hertz, Single phase, 13 amp | |
| Power Rating, Reactor Platform | 1150 W | |
| Net Weight | Control Station | 20 kg (44 lb) |
| Reactor Platform | 78 kg (171.6 lb) | |
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Overall Dimensions XRS Control Cabinet |
29.5 cm W X 40.6 cm D X 66.8 cm H (11.6 in. wide X 16 in. deep X 26.3 in. high) |
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Overall Dimensions Reactor Platform |
90 cm W X 60 cm D X 62 cm H (35.4 in. wide X 23.6 in. deep X 23.6 in. high) Allow for the lid's 20cm overhang at the rear of the platform, and factor in an additional 37 cm to the overall height when the lids are open. |
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| External Computer Connections | Ethernet port supplied for future connection to supervisory host computer | |
| Fuses | 2 Cooper Bussmann S505-10-R 5 x 20 mm 10 A fuses | |
| 合规性 | See Section 5.1 Instructions For Use USD 2875 | |
| Ambient Operating Conditions | 10 – 40 °C, up to 80% relative humidity, non-condensing | |
Allegro XRS 20 biocontainer supplied as a complete, ready-to-use, single-use system
Allegro XRS 20 Biocontainer Tubing & Connection Specifications
| 用途 | Tubing Type | Length | 尺寸 | 连接 |
| Spare addition port | Thermo-elastomer | 50 mm (2 in.) |
4.8 mm ID x 7.9 mm OD (3⁄16 in.ID x 5⁄16 in.OD) |
Swabable female luer |
| Gas inlet tube | Thermo-elastomer | 858 mm (34 in.) |
4.8 mm ID x 7.9 mm OD (3⁄16 in.ID x 5⁄16 in.OD) |
0.2 μm filter with tapered hose tail |
| Platinum Cured Silicone | 50 mm (2 in.) |
6.35 mm ID x 11.11 mm OD (1⁄4 in.ID x 7⁄16 in.OD) |
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| Main liquid addition tube | Thermo-elastomer | 800 mm (32 in.) |
3.18 mm ID x 6.4 mm OD (1⁄8 in.ID x 1⁄4 in.OD) |
6.35 mm (1⁄4 in.)MPC |
| Platinum Cured Silicone | 500 mm (20 in.) |
6.35 mm ID x 11.11 mm OD (1⁄4 in.ID x 7⁄16 in.OD) |
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| Addition tube 2 | Thermo-elastomer | 800 mm (32 in.) |
3.18 mm ID x 6.4 mm OD (1⁄8 in.ID x 1⁄4 in.OD) |
Female luer |
| Platinum Cured Silicone | 500 mm (20 in.) |
3.18 mm ID x 6.4 mm OD (1⁄8 in.ID x 1⁄4 in.OD) |
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| Sampling tube | Thermo-elastomer | 685 mm (27 in.) |
4.8 mm ID x 7.9 mm OD (3⁄16 in.ID x 5⁄16 in.OD) |
Swabable female luer |
| Platinum Cured Silicone | 100 mm (4 in.) |
3.18 mm ID x 6.4 mm OD (1⁄8 in.ID x 1⁄4 in.OD) |
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| Addition tube 1 | Thermo-elastomer | 800 mm (32 in.) |
4.8 mm ID x 7.9 mm OD (3⁄16 in.ID x 5⁄16 in.OD) |
Female luer |
| Platinum Cured Silicone | 500 mm (20 in.) |
4.8 mm ID x 7.9 mm OD (3⁄16 in.ID x 5⁄16 in.OD) |
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| Gas vent tube | Thermo-elastomer | 913 mm (36 in.) |
6.35 mm ID x 11.11 mm OD (1⁄4 in.ID x 7⁄16 in.OD) |
0.2 μm filter with downstream check valve with 1.3 mm (1⁄2 in.) hose tail |
| Drain tube | Platinum Cured Silicone |
1283 mm (50.5 in.) |
6.35 mm ID x 11.11 mm OD (1⁄4 in.ID x 7⁄16 in.OD) |
6.35 mm (1⁄4 in.)MPC |
Bi-Axial Rocker for Better Mixing and Mass Transfer
The XRS bioreactor system rocks on two axes simultaneously (Bi-Axial agitation), producing a low turbulence, swirling pattern within the 3-dimensional XRS 20 Biocontainer.Under similar agitation conditions, the XRS system mixes almost 3 times faster than conventional rockers, and demonstrates much higher mass transfer properties as measured by kLa values.Summary of best mixing times observed in pH equilibration studies, 20 liter working volumes with conventional pH probes1
| 系统 | 条件 | Mixing Time (s) |
| Conventional | Maximum speed and rock angle = 42 rpm, 10.4° | 50 to 98 seconds3 |
| XRS 20 | 75% Max speed, maximum long axis angle, 1/3 short axis angle = 30 rpm, 15° long, 5° short | 16 seconds |
Summary of mass transfer coefficients observed in 20 liter working volumes as measured with nitrogen purge and recovery2
| 系统 | 条件 | KLa per Hour |
| Conventional | Maximum speed and rock angle = 42 rpm, 10.4° | 42 |
| XRS 20 | Maximum speed and angle = 40 rpmv, 15° long, 15° short | 73 |
1 Mixing trial results from 3 repetitions for each device
2 Mass transfer results from 3 repetitions for each device
3 Times significantly different for edge/center measurements
Better Mixing, Better Cell Culture Performance
The superior mixing properties due to the design of the 3-D biocontainer and the bi-axial agitation leads to superior cell culture performance in mammalian suspension systems.With faster delivery of nutrients to the cellular micro-environment (and faster removal of metabolites), the XRS 20 System allows cells to attain higher densities, and with higher overall viabilities, leading to much significantly higher protein expression levels.In the batch culture example cited below, with identical media inputs and seeds, the 颇尔 XRS Bioreactor System produced 18% higher cell densities, and 30% more antibody titer compared to conventional rocker technologies.Summary of side-by-side growth and viability experiments (n=3) at 20 liter working volumes comparing conventional rocker system and 颇尔 XRS 20 system.Simple batch culture of a CHO (Chinese hamster ovary) cell line expressing a monoclonal antibody.
| Part Number | 描述 |
| XRS20BR | XRS 20 生物反应器系统 |
| XRS20IQOQ | XRS 20 Bioreactor System Validation Package IQ/OQ Documentation Package |
| XRS20REGTREE | XRS 20 Bioreactor System Installation Kit |
| 609-40A | Allegro XRS 20 Biocontainer (with User-Fit pH Sensor Probe) Pack of 4 each |
| Allegro XRS 20 Biocontainer Accessories | |
| 509-2297 | 20 Liter, 2D Biocontainer bag with integrated sterilizing filter, Male CPC Connector, gamma irradiated |
| 509-2296 | 5 Liter, 2D Biocontainer with integrated sterilizing filter, Male Luer Connector, gamma irradiated |
| 509-2295 | 1 Liter, 2D Biocontainer with integrated sterilizing filter, Male Luer Connector, gamma irradiated |
| 509-2294 | 500 mL, 2D Biocontainer with integrated sterilizing filter, Male Luer Connector, gamma irradiated |
| 509-0283 | “Y” linker, with 2 Female Luer Connections, 1 Male Luer Connector, gamma irradiated |
| XRS20FOCAB | Spare Fiber Optic Cables |
