Xpansion Multiplate Bioreactor System

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1 USD939 (1) Xpansion Multiplate Bioreactor System Multiplate bioreactor for cell-based product manufacturing Features and Benefits USP Class VI certified materials Designed for adherent cell culture applications Single-use closed bioreactor, from vessel to sensors, reduces risk of contamination -D multiplate design allows easy adaptation from traditional multitray systems Real-time control and monitoring ensures reproducibility and traceability Reduced operations results in process simplification, flexibility, and assurance

2 The Xpansion multiplate bioreactor is part of the Pall Life Sciences single-use bioreactor family, designed for shear-sensitive adherent cell applications, such as cultivation of stem cells. The Xpansion multiplate bioreactor was developed for safe, large-scale production of traditional -D cell cultures. The multiplate structure is comprised of a large cell growth surface area (up to 1,400 cm ), while the compact design enables the elimination of the gas phase between the plates. This gas phase is replaced by an automatically controlled aeration system which provides advanced gas diffusion. Control is automatic via disposable ph and dissolved oxygen (DO) sensors. Temperature monitoring and agitation control are also included. Xpansion bioreactors offer the capability of monitoring cell morphology and density through the use of an optional digital holographic microscope Xpansion System Components 7 The Xpansion system includes a single-use bioreactor, docking station and a controller Single-Use Bioreactor with Stacked Multiplate Design Comprised of stacked hydrophilized polystyrene radial plates, the Xpansion bioreactor is designed to promote cell growth on the top of each plate; each plate has a hole in the center. The stacking of these plates forms the central column which allows circulation of the medium in the bioreactor and gas exchange. The plates are covered by an outer tube, a head plate on the top and a base plate on the bottom. On the head plate, there are: Six sensor connectors: ph, DO, and four optional sensors Three viewing windows for use with optional holographic microscope Two vent filters Two gas filters (in and out) for aeration system One thermowell port One sampling port In the bottom side of the bioreactor, there are: Two fluid operation ports (e.g., inoculation, harvest, etc.) One magnetic impeller The Xpansion Multiplate Bioreactor Gas lines C-Flex tubing and silicone 3/16 in. ID, 0. μm (in & out) hydrophobic filters (PTFE, polyester, polypropylene) Vent.1 C-Flex 3/16 in. ID, 0. μm hydrophobic filters (PTFE, polyester, polypropylene) 3 Sampling port C-Flex 3/16 in. ID with needleless connector for sampling with luer syringe + oneway valve 4 Top part Clear polystyrene 5 Cell surface Cell culture plasma-treated clear polystyrene plates 6 Aeration Polypropylene + polycarbonate support 7 Aeration tubing Silicone 0.58 in. ID x 0.77 in. OD 8 Outer tube Polyvinyl chloride 9 Stirrer cover Clear polystyrene 10 Impeller Ultra-high-molecular-weight polyethylene 11 Bearing Polyether ether ketone 1 Bottom part Clear polystyrene 13 Liquid in/out C-Flex Clear 374 Tubing 3/8 in. ID, CPC MPC male tubing connector, 0. μm hydrophobic filters Sealing material Resin An Xpansion Plate

3 Docking Station The bioreactor docks to a station that includes a magnetic drive stirring unit powering the magnetic impeller. Control of agitation speed is integrated in the controller. The setpoint is defined via the screen on the front side of the controller. Controller The controller has measurement/control hardware and a gassing system with a digital control. Features of the Xpansion controller include: Graphic user interface with color display and touch screen operation with Administrator and Operator security levels Integrated transmitters for temperature, disposable DO and ph sensors Integrated control loops for DO and ph Agitation control (speed range from 5 to 50 rpm) Temperature monitoring DO and ph sensor patches arrive precalibrated; data are transferred via a USB key to the controller In-process DO and ph can be recalibrated Trend display for up to four process values (ph, DO, T, gas flow rate) Controller Gas Module The controller is connected to the user s gas supply line. Its gas outlet is connected to the gas in filter of the bioreactor. Gas composition to be injected in the bioreactor is regulated by controller solenoid gas valves. The flow rate of the mixed gas is adjusted by a massflow controller (0-00 ml/min). The controller gas module contains: One gas diffuser outlet Four solenoid valves of Air, N, O, and CO One Mass Flow Controller for mixed gas flow control Data Management The Xpansion system has one ethernet port for data communication/ acquisition. It can be linked to egraph (optional software and computer provided by Pall Life Sciences). egraph is installed on a host PC and provides data acquisition for all process values. Xpansion Controller and Docking Station Controller Height Depth Width Weight Power supply Interface Stirrer speed Integrated measurement module One point recalibration function Gas options O N CO Air Temperature monitoring 50 cm (19.7 in.) 40 cm (15.7 in.) 5 cm (9.8 in.) 15 kg (33 lbs.) VAC, Hz Ethernet USB host 5 50 rpm Disposable DO sensor Disposable ph sensor Temperature Disposable DO sensor Disposable ph sensor 0 50 ºC (3 1 ºF) Gas Requirements Gases Application Specification Air ph control Compressed air medical grade Outlet pressure between 1 and bars ( PSI) CO ph control Pure CO Oxygen DO control Medical grade oxygen Nitrogen DO control Medical grade nitrogen (optional) 3

4 Performance Standard Cell Environment Preservation As in multitray stacks, cells adhere and grow on hydrophilized polystyrene plates and are harvested using a cell dissociation reagent. Because of its specific design, the system maintains the same environment as T-flasks or multitray stacks, and enables implementation of a process easily-adapted from these traditional methods. Cell Culture Parameters (ph, DO) Control and Temperature Monitoring The Xpansion head plate includes patch ports for optical non-invasive measurement of ph and DO. For contamination risk elimination, the determination of ph and DO is based upon the principle of fluorescence. Depending on the DO and ph measurement, gas regulation is activated via the controller according to users requirements. Temperature is measured for monitoring via a PT100 reusable sensor installed in a thermowell of the bioreactor. The heating is done via an incubator or in a warm room. Each measure (ph, DO and T) is associated with an alarm. Optical ph Sensor Performance Specifications Detection range ph Accuracy ph Precision ph 7.0 Response time (t90 ) 30 seconds Calibration Shipped pre-calibrated, (calibration files on USB key provided with the reactor). One point calibration required. USP Class VI certified Optical DO Sensor Performance Specifications Detection range 0-150% air saturation Accuracy +/- DO 15-75% air saturation Precision +/- DO % air saturation Response time (t90 ) < 15 seconds Calibration Shipped pre-calibrated, (calibration files on USB key provided with the reactor). One point calibration required. USP Class VI certified Aeration System Gas aeration occurs depending on ph and DO control limits set by the users. Gas composition control depends on ph and DO measurement in the bioreactor. The gas coming from the controller enters via the gas in filter of the bioreactor and passes through very thin silicone tubing placed in the central column. The gas inlet and outlet include pre- installed hydrophobic aeration filters. Gases diffuse through the tubing. Homogenization by Medium Circulation Medium circulation is coupled with the aeration system which depends on ph and DO control. The medium can also circulate in the bioreactor independent of gas aeration according to users requirements. Each plate contains 16 radial channels supporting media flow rate. The rotation of the impeller pushes the liquid upward, first vertically through the first plate channel, then horizontally over the plate, then up again to the second plate, etc. The Xpansion Bioreactor Aeration System Cell Morphology and Density Monitoring Cell density and morphology are monitored via a specialized holographic microscope developed by Ovizio Imaging Systems NV and available through collaboration with Pall Life Sciences. This technology provides a platform to observe cells on multiple layers with high image quality. Circulation of Culture Medium throughout the Xpansion Bioreactor Plates 4

5 Technical Specifications Bioreactors Xpansion MPB 10 Xpansion MPB 50 Xpansion MPB 100 Xpansion MPB 00 Number of plates Cell culture surface 6,10 cm (949 in. ) 30,600 cm (4,743 in. ) 61,00 cm (9,486 in. ) 1,400 cm (18,97 in. ) Media volume / surface 0.6 ml/cm 0.18 ml/cm 0.18 ml/cm 0.18 ml/cm area ratio Bioreactor volume 1.6 L 5.6 L 11. L 1.9 L Central column volume 6 ml 13 ml 63 ml 57 ml Overall weight.5 kg (5.6 lbs.) 6.9 kg (15. lbs.) 1.5 kg (7.5 lbs.) 3.4 kg (50.7 lbs.) Overall height 9 cm (11.4 in.) 47 cm (18.5 in.) 55 cm (1.6 in.) 81 cm (31.9 in.) Minimum space requirement 49 cm x 48 cm x 40 cm 67 cm x 48 cm x 40 cm 75 cm x 48 cm x 40 cm 99 cm x 48 cm x 40 cm for the bioreactor and (19 in. x 19 in. x 16 in.) (6 in. x 19 in. x 16 in.) (30 in. x 19 in. x 16 in.) (39 in. x 19 in. x 16 in.) docking station (H x W x D) Plate surface 61 cm (94.9 in. ) Plate thickness 0.1 cm (0.04 in.) Distance between each plate 0.16 cm (0.06 in.) Volume between each plate 98 ml Head space volume 50 ml Sterilization Gamma-irradiated to > 5 kgy Ordering Information Category Material Description Ref # Hardware Skid 1 controller, optical fibers for ph and DO, 1 temperature probe (PT-100), (EU) 1 driver (magnetic stirring plate), 5 M of Festo gas tubing (US) Docking station Bioreactor support for inside incubator Harvest station Mechanical cell detachment device for harvest SU D3HM microscope* Holographic; for observation of up to top 10 plates of the system (EU) (US) Lift* Safe movement of bioreactor from package to incubator and during (EU) observation under microscope (highly recommended for XP-100 and 00) (US) egraph computer* Process data recording (ph, DO, temperature and events); 1 computer can be used with up to 10 controllers Consumables Bioreactor XP-10: 10-plate bioreactor XP-50: 50-plate bioreactor 8101 XP-100: 100-plate bioreactor XP-00: 00-plate bioreactor Seeding manifold* L bottle with female MPC connector used to transfer cell suspension into seeding container S Note: for XP-10 the manifold can be directly connected to the bioreactor; for XP-50, XP-100 and XP-00, intermediate container must be used. Pooling manifold* Sterile 10 L bottle with female MPC connector used for pooling reagent bottles (cell culture medium, PBS, Trypsine,...) and transfer into Pall D BPV bag * Optional equipment and consumables Corporate Headquarters Port Washington, NY, USA toll free (USA) phone biopharm@pall.com European Headquarters Fribourg, Switzerland +41 (0) phone LifeSciences.EU@pall.com Asia-Pacific Headquarters Singapore phone sgcustomerservice@pall.com Visit us on the Web at us at bioreactors@pall.com International Offices Pall Corporation has offices and plants throughout the world in: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, New Zealand, Norway, Philippines, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam. Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly. 015, Pall Corporation. Pall,, and Xpansion are trademarks of Pall Corporation. indicates a trademark registered in the USA and TM indicates a common law trademark. Filtration. Separation. Solution. is a service mark of Pall Corporation. CPC and MPC are trademarks of Colder Products Company; C-Flex is a trademark of Cole-Palmer 3/15, PDF, GN USD939 (1)

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