Xuri™ Cell Expansion System W25
Contents
1. Client computer Tray Xuri Cell Expansion System W25 Base Unit Xuri Cell Expansion W25 Installed with Rocker temperature sensors Environmental Control Unit UNICORN software scale embedded controller Gas flow mix controller and dual hard drives pH and DO sensors System setup and integration of subunits Xuri Cell Expansion System W25 Base Unit Xuri Cell Expansion W25 Pump e Acid base flow e Rocking e Feed harvest flow ae e Weight a a e Media addition measurement e Temperature UNICORN software measurement Administration Xuri Cell Expansion W25 Environmental Control Unit System control Method editor e Gas flow mix Controller with dual hard drives Evaluation e pH measurement e DO measurement TE I o otaa cu S UNICORN J SCADA database l not included n TTT en a i sar gt ome gt UNICORN software E mail At home or within notifications enterprise network Fig 2 Xuri Cell Expansion System W25 overview The System Control module on the client computer is used to start and monitor the cultivation process One UNICORN client can control up to three Xuri Cell Expansion W25 systems simultaneously SCADA supervisory control and data acquisition OPC open platform communications LAN local area network 2 29 0618 5 AA Designed for use in a regulated environment The Xuri Cell Expansion System W25 is designed to meet the demands and standards that are2. 1 7 kg 3a ko 3 9 kg 4 8 kg 3 8 kg 100 to 240 V 50 to 60 Hz 1500 VA IP 21 Normal capacity Fast fill capacity 1 3 l min 3 5 l min 0 2 I min 0 5 I min 0 7 I min 1 7 l min 15 C to 32 C 20 to 80 noncondensing 2 to 40 rom 2 to 12 15 to 100 0 5 t025 kg 0 050 kg 1 of load kg Pt100 Class A 2 C tO 50C 20 C or ambient temperature 5 C to 40 C 0 57 multiplied should not exceed 240 rpm degrees For example if the rocking angle is set to 12 degrees the rocking speed should not be set higher than 20 rpm Xuri Cell Expansion W25 Environmental Control Unit Gas flow control range O to 1000 ml min Gas flow total accuracy process value to reference flow 10 ml min 3 of read value Fast fill flow 3 min CO control range 0 to 15 0 3 3 of read value when mixed only with air N CO measurement accuracy Total CO accuracy process value to reference CO content 0 7 3 of read value O control range 0 to 50 when mixed with N 21 to 50 when mixed with air 0 6 1 of read value within 0 to 50 when mixed only with air N OF measurement accuracy Total O accuracy 1 2 1 of read value pH measurement range 4 5to 85 OH measurement accuracy 0 05 for pH 6 75 t0 7 25 0 1 for pH 6 5 to 7 5 PH control range 6 0 to 8 0 Total pH accuracy process value to reference pH 0 1 for pH 6 75 to 7 25 0 15 for pH 6 5 to 7 5 DO measurement r
3. CO concentrations and transmitters for pH and DO Table 1 Two Environmental Control Unit configurations are available e CO 0 and pH e CO 0 pH and DO The most suitable Environmental Control Unit configuration will depend on the specific application Xuri Cell Expansion W25 Pump The Xuri Cell Expansion W25 pump is a peristaltic unit incorporating two roller pumps for feed harvest and PH control The pump design makes tubing installation convenient and easy Tubing sizes from 0 5 mm 1 50 to 4 8 mm 3 16 internal diameter can be used to support flow rates fom 0 07 to 100 ml min Flow rate is regulated by weight feedback from the scale and is controlled by automatic adjustments of the pump speed Manual adjustment of the flow rate is also possible Media handling and perfusion using calibrated pumps Calibration of pumps can be performed manually or automatically during an ongoing perfusion process Automatic calibration is possible for flow rates above 3 5 l d and is easily managed by entering the tubing diameter Automated pH control To minimize fluctuations in pH during adjustments with CO base or acid base the flow rate of the acid base pumps needs to be rigorously monitored The Xuri Cell Expansion System W25 uses combined information from the load cells the current process pH value the pump tubing diameter and the acid base molarity for calculation of the needed flow rate during the run UNICORN softw
4. 5 is a single use Cell Expansion Cell Expansion System W25 Fig 1 Xuri Cell Expansion System W25 bioreactor system functionally closed system meaning that the chance of contamination between different patient samples or with adventitious agents is minimized Reach high cell densities with confidence Perfusion is easy on the Xuri Cell Expansion System W25 Perfusion allows high cell densities to be obtained in the Cellbag This means that an entire therapeutic dose can be obtained in one closed bioreactor system eliminating the difficulties with combining culture vessels as is required with manual systems High cell density and reduced manufacturing footprint allows you to maximize use of your limited manufacturing space Be in charge of your cell expansion with process monitoring and remote control The Xuri Cell Expansion System W25 is designed to put complete control of the culture in your hands whether you are standing next to the bioreactor or at home in the evening By giving you control of process parameters such as rocking speed DO pH and perfusion rate you can optimize your cell culture protocol to obtain therapeutic cells in the most efficient manner for you Once the culture is setup remote monitoring gives you the peace of mind to leave it Knowing that you will be alerted if anything changes from the limits you set Lid Graphical user interface Xuri Cell Expansion W25 Pump Peristaltic pump
5. GE Healthcare Life Sciences Data file 29 0618 52 AA ur The single use Xuri Cell Expansion System W25 is a reliable and intuitive cell expansion device for working volumes up to 25 Fig 1 The system is based on the well known WAVE rocking technology that provides mixing and aeration to the culture With the Xuri Cell Expansion System W25 the rocking is enhanced with features such as advanced sensors and intelligent control strategies System operation is easily managed via the intuitive and user friendly UNICORN system control software The system is designed for fast installation and convenient handling and delivers a reliable and accurate performance suitable for research process development and manufacturing operations eTM Xuri Cell Expansion System W25 offers the following benefits e Minimize the risk of cell contamination with a functionally closed system e Reach high cell densities with confidence e Be in charge of your cell expansion with process monitoring and remote control e Designed for use in a regulated environment Applications Xuri Cell Expansion System W25 is intended for a variety of cell culture applications incuding e Rapid production of clinical grade T lymphocytes e Perfusion culture of T lymphocytes e Perfusion culture of human natural killer cells System benefits Minimize the risk of cell contamination with a functionally closed system The Xuri Cell Expansion System W2
6. access to all operations data and alarm conditions A dynamic graphical user interface shows the real time status of the run while data are automatically saved From the UNICORN software the system is easily configured to trigger an alarm when certain conditions are met Individual deviation alarms can be set for all essential 29 0618 5 AA 5 parameters heating gas flow CO2 pH and DO Alarm sensitivity and delay is defined by the user If such an alarm condition is triggered the source of the alarm is highlighted in the graphical user interface and an alarm dialog is displayed The alarm dialog displays information about the alarm such as date and time of occurrence as well as a help text describing the cause and how to solve the problem The system is easily configued to send email notifications of alarms and errors Regulatory readiness The Xuri Cell Expansion System W25 is suitable for biomanufacturing of regulated products under various Quality Management Systems The use of UNICORN software in a 21 CFR Part 11 and GAMP 5 compliant manner enables use of the system in a regulated environment Individual user access permissions can be set and individual users are password protected Active processes can be locked to enable unattended operations without the risk of unauthorized interference All records are stored in a single unalterable database including results and extended run documentation Additional validation suppor
7. ange 0 to 250 air saturation 5 air saturation excl atmospheric pressure variations DO measurement accuracy DO control range 0 to 100 air saturation 10 air saturation excl atmospheric pressure variations Total DO accuracy process value to reference DO Xuri Cell Expansion W25 Pump 100 ml to 144 l d 0 07 to 100 ml min Pump flow rate range 0 1 ml min 5 of read value after calibration Pump flow accuracy Accumulated pumped volume accuracy 10 of measured volume i d 0 5 to 4 8 mm 1 50 to 3 16 wall thickness 1 6 mm 1 16 Supported tubing dimensions 29 0618 5 AA 7 system components Product Description Xuri Cell Expansion System W25 Base unit Base Unit Xuri Cell Expansion System W25 Gas flow mix and pH Environmental Control Unit pH Xuri Cell Expansion System W25 Gas flow mix pH and DO Environmental Control Unit Full Xuri Cell Expansion System W25 Pump Pump UNICORN 6 3 2 WrkStn pure BP Software and license UNICORN 6 3 Remote License UNICORN 6 3 Dry license Tray 10 Tray 20 Tray 50 Lid 10 Lid 20 Lid 50 Filter heater Bag sensor adaptor 2 5 m assembly Fiber cable for pH and DO control Related literature Code number UNICORN 6 3 Manual Package 29 0234 67 UNICORN 6 control software data file 28 9573 46 Validation Support File UNICORN 6 3 11 0029 94 For local office contact information visit www gelifesciences com contact www gelifescien
8. are UNICORN system control software consists of four modules Administration Method Editor System Control and Evaluation A comprehensive help tool is also included Administration The Administration module is used to administer all functions of the UNICORN software Available functions include user and email setup controlling access to groups and network users defining and editing system properties database management and logging records of usage and activity Method editor Instructions to control a bioreactor run can be defined in a method The Method Editor module is used to create edit save and work with methods An existing method can be changed to simplify the editing process Individual changes can be saved for later use on systems having the same instrument and component configuration System control The System Control module is used to connect to the system as well as to start view and control a run Fig 7 Default parameter values for an instrument can be viewed and edited in the System Settings dialog before a run is started Or during an ongoing run using manual instructions It is also possible to connect to other systems The user friendly and intuitive Process Picture pane enables manual interaction with the system and provides status of the run parameters Data is shown in the process picture but can also be viewed as curves in the Charts tab and as numerical values in the Run Data pane Curves and infor
9. ces com GE Healthcare UK Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA UK imagination at work GE imagination at work and GE monogram are trademarks of General Electric Company Cellbag UNICORN WAVE and Xuri are trademarks of GE Healthcare companies DeltaV is a trademark of Emerson Electric Co Windows and Windows XP are registered trademarks of Microsoft Corporation Any use of UNICORN software is subject to GE Healthcare Standard Software End User License Agreement for Life Sciences Software Products A copy of this Standard Software End User License Agreement is available on request Cellbag bioreactors with integrated optical sensors are sold under a sublicense from Sartorius Stedim Biotech under US patent numbers 6 673 532 7 041 493 and or its foreign equivalents 2013 General Electric Company All rights reserved First published Jul 2013 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them A copy of these terms and conditions is available on request Contact your local GE Healthcare representative for the most current information GE Healthcare UK Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA UK GE Healthcare Europe GmbH Munzinger Strasse 5 D 79111 Freiburg Germany GE Healthcare Bio Sciences Corp 800 Centennial Avenue P O Box 1327 Piscataway NJ 08855 1327 USA GE Hea
10. de a suitable environment for cell growth while minimizing the cross contamination risk The bags are manufactured from multilayer laminated clear USP Class VI plastics and are easily connected to the full suite of Xuri Cell Expansion cell culture purification and fluid handling products The selection of Cellbag bioreactors is listed in Table 2 For more information about Cellbag bioreactors see data file 29 0618 52 Optical DO sensor embedded A Air outlet filter Optional tubing Air inlet filter Inoculation harvest lines Optical pH sensor embedded in bag Cellbag rod Optional tubing Optional Needleless tubing sampling port Fig 8 Presentation of typical Cellbag bioreactor fittings Table 2 Selection of Cellbag bioreactor sizes Cellbag bioreactor Working volume Cellbag 2 300 ml to 1 Cellbag 10 500 ml to 5 Cellbag 20 Lio 10 Cellbag 22 1to 101 Cellbag 50 5 0 25 All Cellbag bioreactor sizes are available with internal perfusion filter for perfusion cultures and or can be equipped with single use optical pH pHOPT and DO DOOPT II sensors t Cellbag bioreactors with optical sensors require 300 ml minimal working volume Depending on application and configuration it might be possible to cultivate below the recommended minimum volume However it is highly recommended to stay above this volume for applications that require high agitation and pH and DO control The
11. i Cell Expansion W25 Environmental Control Unit Table 1 Environmental Control Unit overview Feature CO O air mix controller Description Depending on the configuration air is mixed with CO and or O according to the set points Nitrogen may be used instead of air for maintaining a low oxygen environment for near anaerobic applications Gas flow controller The gas mix flow is measured and controlled by a mass flow controller MFC A correct volumetric flow is achieved by compensation for CO concentration Quick filling of gas into the Cellbag bioreactor enabled by the fast fill function significantly reduces start up time An alarm will inform the user if pressure sensors detect under or overpressure at the gas inlets or within the Cellbag bioreactor pH The pH is measured with optical pH sensors measurement preinstalled in Cellbag bioreactors of DHOPT type The sensor is connected to the Environmental Control Unit via an optical fiber cable DO The DO level is measured with optical DO sensors measurement preinstalled in Cellbag bioreactors of DOOPT type The sensor is connected to the Environmental Control Unit via an optical fiber cable The Xuri Cell Expansion W25 Environmental Control Unit is a compact unit with multiple functions The unit is primarily used for providing gas to the culture and for monitoring of pH and DO The unit contains a controller for mass flow sensors for gas pressure and O and
12. lthcare Japan Corporation Sanken Bldg 3 25 1 Hyakunincho Shinjuku ku Tokyo 169 0073 Japan 29 0618 5 AA 07 2013
13. mation about the run are saved in a database which can be opened in the Evaluation module The default view shows the most commonly curves used The user may customize which curves to display and the color and style of the displayed curves gt J I gt r p PX wave ings G ED 00 MORo aE D z o baa e 02 21 B Sampling 60 min IN Reading On Off Vz Cycle time 60 s S o Gas flow 0 00 L min Rocking 20 rpm gt iceci_ i Angie 6 j ae arrose Temp 31 8 P Setpoint Alert 00 Temp Cellbag controller CHP 1B Media control eee M Cellbag Media control Weight 10 45 Weight Fed Batch I p E Rocking Feed 20 00 L gt ll cee 2a sd Harvest Daa a S Fig 7 Monitoring and controlling all aspects of the culture is managed through the user friendly interface Evaluation In the Evaluation module content of the result files can be viewed analyzed and compiled as reports Reports can be customized saved and printed Automation of process parameters in pH and DO control The UNICORN software automatically sets the desired PID control parameters based on Cellbag bioreactor size and gas flow set point The system also adapts the parameters during the run for optimization to reach a new set point or to maintain a current set point Proportional integral derivative Alarms notifications and data logging The UNICORN software allows easy
14. required in a regulated environment The documentation is extensive and includes material certificates system specifications installation and operational qualification IQ OQ protocols and a detailed user manual The UNICORN software Is suitable for use in a manner that complies with 21 CFR Part 11 and Good Automated Manufacturing Practice GAMP 5 System overview Xuri Cell Expansion System W25 components The Xuri Cell Expansion System W25 consists of a base unit a gas mixer and a pump all operated by the UNICORN software installed on a client computer The base unit is the main unit and is used together with a tray and a disposable Cellbag bioreactor The base unit has multiple functions amongst them heating culture mixing and weight measurement The gas mixer delivers gas of a defined composition to the culture and is used together with the optical sensors of the Cellbag bioreactor for online control of culture pH and DO Liquid is delivered accurately to the culture by the Xuri Cell Expansion W25 pump The pump unit has a flow range covering multiple applications from additions of acid and base to fresh medium for perfusion culture An overview of the Xuri Cell Expansion System W25 is shown in Figure 2 The individual components are described in detail below A B Fig 3 A Xuri Cell Expansion System W25 in tilt position B The ergonomic design makes activities such as sampling and harvest convenient and ea
15. size and the media volume Temperature sensors Fig 5 Integrated temperature sensors for convenient handling and reliable temperature control 29 0618 5 AA 3 Mixing and gas transfer The adjustable rocking parameters are speed angle and motion The parameter settings in combination with the cell culture volume affect the mixing and gas transfer rate in the Cellbag bioreactor The speed parameter determines the number of rocking cycles per minute and the angle parameter relates to the tray s degree of tilting at the turning Rocking profile 15 10 10 Angle An Oo Ww O 0 5 1 0 1 5 2 0 2 5 3 0 Time s 20 10 10 Angular velocity s O 20 O 0 5 1 0 1 5 2 0 2 5 3 0 Time s Rocking profile 100 10 Angle n o o 10 O 0 5 1 0 1 5 2 0 2 5 3 0 Time s Q 20 gt 10 O Ke w Q 5 gt 10 oO Cc S0 O 0 5 1 0 1 5 2 0 2 5 3 0 Time s Fig 6 A user defined rocking motion can be selected in UNICORN system control software The wave can be aggressive or gentle with subsequent impact on mixing and gas transfer in the culture points The motion parameter determines the acceleration profile The lowest motion parameter setting 15 gives an almost constant speed throughout the rocking cycle whereas the highest setting 100 gives a faster speed in the middle of the cycle and slower at the turning points Fig 6 A lower percent setting will give a more aggressive mixing
16. sy Xuri Cell Expansion W5 base unit The base unit is the main hardware unit of the system and provides mixing through the rocking reliable temperature measurement from integrated sensors and accurate weight measurement from integrated load cells The ergonomic design makes handling convenient and easy The ability to handle the bioreactor in a tilt position facilitates sampling and harvest Fig 3 The minimal footprint facilitates placement when space is limited Trays and lids Trays are available in three different sizes for culturing of up to 51 101 and 25 The trays are easily attached to the base unit when in the tilt position A snap lock mechanism allows Cellbag bioreactors to be correctly installed and rapidly changed Fig 4 To protect light sensitive components of the culture medium and to prolong the life of the optical sensors lids are available for all tray sizes Snap locks Fig 4 The tray has an easy lock mechanism for convenient and proper attachment of Cellbag bioreactors Temperature control Reliable efficient and evenly distributed heating is provided by the tray heater plate The temperature measurement is managed by sensors integrated in the rocker base unit Fig 5 To minimize the risk for overheating heating is only enabled when the base unit is in motion For an accurate stable and fast temperature control the heater power output is automatically adjusted based on the Cellbag bioreactor
17. t includes comprehensive documentation on control system validation as well as IQ OQ services Available validation support documentation includes e Detailed description of the development model used for UNICORN software e 21CFR Part 11 system assessment in checklist format e Audit report and 21 CFR Part 11 conclusion on functionality by an external independent expert Networking capabilities UNICORN software operates in Windows XP and Windows 7 environments and the network ability allows real time control from a remote or local computer Communication is Ethernet based and each instrument is controlled by a dedicated instrument server One database can be connected to 32 systems and up to three instruments can be controlled simultaneously from one UNICORN client Results are saved locally in the base unit during the run and then stored on the database server Because results and instructions are saved locally on the embedded drives a run can continue even in the event of a network communication failure UNICORN software can be integrated in a supervisory control and data acquisition SCADA system such as the Emerson DeltaV control system using the UNICORN OPC server 6 29 0618 5 AA Cellbag bioreactors Cellbag bioreactors are single use bags for the noninvasive mixing of culture medium and cells during cultivation Fig 8 Cellbag bioreactors require no sterilization or cleaning steps The disposable bioreactors provi
18. temperature pH and DO sensors need to be submerged in liquid throughout the complete rocking cycle to function correctly System specifications System specifications are listed in Table 3 Table 3 Xuri Cell Expansion W25 specifications General system specifications Control system Dimensions W x H x D Base unit Tray 10 Tray 20 Tray 50 Lid 10 Lid 20 Lid 50 Environmental Control Unit Pump 25 Weight Base unit Tray 10 Tray 20 Tray 50 Lid 10 Lid 20 Lid 50 Environmental Control Unit Pump 25 Power supply Power consumption Enclosure protective class Gas supply External air supply 1 0 to 1 5 bar External CO supply 1 0 to 1 5 bar External O supply 1 0 to 1 5 bar Environmental aspects Operating ambient temperature range Operating humidity range Xuri Cell Expansion System W25 base unit Rocking speed control range Rocking angle control range Rocking motion control range Media weight control range Scale absolute accuracy Temperature sensor Temperature measurement range Temperature control range Temperature control accuracy incl measurement error 1 When cultivating in a 50 Cellbag bioreactor at maximum working volume of 25 rocking speed and angle UNICORN 6 3 or later version 404 x 560 x 205 mm 475 x 430 x 60 mm 740 x 480 x 70 mm 800 x 610 x 70 mm 475 x 430 x 230 mm 740 x 480 x 245 mm 800 x 610 x 260 mm 276 x 360 x 117 mm 275 x 280 x 115 mm 24 kg 4 5 kg 7 3 kg 9 5 kg
19. with higher gas transfer rates A higher setting will result in a smoother wave suitable for more delicate applications such as adherent cultivation on microcarriers 4 29 0618 5 AA Weight measurement Load cells integrated in the base unit provide accurate and continuous weight measurement of the culture and eliminate the need for external scales The load cells communicate with the system control function for proper media handling and for tailored regulation of pH and temperature The weight measurement functionality is also used for automatic calibration of the pump in perfusion cultures Adjustable feet enables equal weight distribution between the load cells also on non level surfaces for increased precision of the weight measurement Data storage and communication All run data and control parameters are stored on two independent mirrored solid state drives integrated in the base unit Thus once cultivation has been started and data from the instrument modules have been collected the run can continue without the need for a network connection The use of two solid state drives enables culturing without losing any data even if only one drive is functional After a run data is stored in a UNICORN database on an external computer For facilitated integration into a larger manufacturing operation the base unit also contains software for enabling direct communication with the system via an open platform communication OPC link Xur
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