32
WAVE BIOREACTOR™
CELLBAG™
HOT LIPS TUBE SEALER™
WAVE MIXER™
STERILE TUBE FUSER
WAVEPOD™
c2
Innovate, never imitateGE Healthcare (GEHC) WAVE Products Group is a research-based company that develops and manufactures
innovative process equipment for the pharmaceutical and biotechnology industries. Since 1999 our focus has
been on developing disposable bioprocess equipment for operations traditionally requiring stainless-steel
tanks and piping. Key products, such as the WAVE Bioreactor, WAVE Mixer and Sterile Tube Fuser, feature
disposable contact materials that eliminate cleaning and validation, thereby reducing costs in operations ranging
from cell culture, media preparation, buffer dissolution and thawing process intermediates to patient-specific cell
therapy in hospitals. These unique, patented devices can be installed and commissioned rapidly, drastically
reducing the time-to-market for biological products. Our equipment is in use in hundreds of companies
worldwide, both for R&D and commercial applications.
OUR PHILOSOPHY
CONTENTS
2 TESTIMONIALS
4 WAVE BIOREACTOR
12 WAVE MIXER
18 TUBE FUSER & TUBE SEALER
22 DISPOSABLE BIOPROCESSING
24 TRAINING & SERVICE
28 HISTORY
INNOVATEA LONG LIST OF FIRSTSFirst scalable disposable bioreactor l First
disposable bioreactor for large-scale virus
production l First disposable large-scale
bioreactor suitable for cGMP production of a
commercial therapeutic l First disposable bioreactor
for large-scale attachment culture l First disposable
bioreactor with internal perfusion filters l First
disposable bioreactor for cell and gene therapy l
First disposable bioreactor for large-scale plant
culture l First disposable bioreactor for microbial
culture l Extensive culture protocols and
technical support for many different cell lines and
applications l First flexible oxygen and pH sensors
for bioreactors l First automated perfusion
controllers l First user-customized disposable
bioreactors l First ultra-low cost disposable
bioreactors for vaccine production l First
calibratable and reusable optical oxygen sensors l
First mixing systems for flat bags to 500 liters l
First thawing systems for bags without a water
bath l First validatable aseptic tube welders l
First automated aseptic tube sealers
1
“The Wave Bioreactor has a lower requirement for facility utilities and can be retrofitted into our existing facilities.”
P. CLARKE, VP PRODUCTION AND TECHNICAL PROCESSES
Introgen Therapeutics, 2006
“I am amazed at how easy this reactor is to use...”
P. PIERGIOVANNI, PROFESSOR OF CHEMICAL ENGINEERING
Lafayette College, 2006
“We are very pleased to be able to work with WAVE as we proceed to expand the production of our pandemic and seasonal flu vaccine candidates. The process is reliable and can be readily scaled up.”
R. SINGHVI, PRESIDENT AND CEO
Novavax, 2005
2
“A disposable bioreactor offers advantages in the areas of cleaning, sterilization, validation, set-up and turn-around time between runs...we have demonstrated that systems run with a 25L, 100L or 500L working volume are comparable for cell growth, protein production, glucose consumption and lactate production.”
L. PIERCE & P. SHABRAM
PacificGMP/Ventana Biosciences, 2004
“One reason for...rapid maturity is that it cultures trillions of drug-producing cells in disposable plastic bags instead of using costly stainless steel vats...”
V. CICCARONE, ASSOCIATE DIRECTOR, GENE EXPRESSION
Macrogenics, 2005
REALIZE
3
The Ideal Device for Cell CultureWAVE Bioreactor is the ideal device for cell culture. Culture medium and cells contact only a presterile, disposablechamber called a CellbagTM that is placed on a special rocking platform. The rocking motion of this platform induceswaves in the culture fluid. These waves provide mixing and oxygen transfer, resulting in a perfect environment for cell growth that can easily support over 10 x 106 cells/ml. The bioreactor requires no cleaning or sterilization, providing the ultimate ease in operation and protection against cross-contamination.
CELL CULTURE
WAVE BIOREACTOR™
4
Cell culturemedia
WaveRockingmotion Wave
Wave action sweeps up cells and prevents settling
GROWCELLS
5
6
Features Applications
LitersSYSTEM 20/50
1-25
LiterSYSTEM 2/10
0.1-5 LitersSYSTEM 200
10-100
SINGLE USENo cleaning, cross-contamination, or validation. Cells contact only disposable sterile biocompatible plastics. All materials conform to USP Class VI and ISO 10993.
CLOSED SYSTEMCellbag bioreactors, including all fittings and filters, aredelivered sterile and ready for use. Suitable for cGMPcommercial production. No biosafety cabinet is requiredfor inoculation or sampling.
VERSATILEMultiple instrument configurations specifically designed for suspension, microcarrier, batch, fed-batch or perfusion culture.
SCALABLESpinners, roller bottles, and similar systems are not scalable due to inherently limited mass transfer surface area. The WAVE Bioreactor has no such limits. Operation up to 580 liters working volume has been demonstrated.
MONOCLONAL ANTIBODIESThe WAVE Bioreactor has been used extensively for monoclonal antibody production. Culture can be started at low volume and then fresh media added whenever thecell count is sufficiently high. This enables inoculum scaleup without transfers.
Batches ranging from 100ml to 580 liters have been runwith cell densities over 10x106 cells/ml and productivityand product quality comparable to stirred tank bioreactors.Dissolved oxygen concentrations are not limiting andremain above 50% saturation.
ANCHORAGE DEPENDENT CELLS Agitation in the WAVE Bioreactor is powerful enough to mix and aerate the culture, yet it is gentle enough to cultivate anchorage dependent cells on various microcarriers. The wave motion prevents settling and provides oxygenation without bubbles.
CELL CULTURE
WAVE BIOREACTOR
7
VIRUS PRODUCTIONThe WAVE Bioreactor provides a closed system that is idealfor virus production. In a gene therapy application, human293 cells have been grown in suspension and then infectedwith recombinant adenovirus. Cells grew to 4x106/ml andvirus production was 100,000 virus particles/cell.
The WAVE Bioreactor produces viruses under complete containment without the need for a biosafety cabinet.
cGMP PRODUCTIONWAVE Bioreactors are in use in cGMP applications producing inoculum for large conventional bioreactors, and also for clinical and commercial production of human therapeutics.
Reduced cleaning and validation requirements make thisan ideal system for cGMP applications.
CUSTOM USES The WAVE Bioreactor has many other uses, such as keeping in-process inoculum pools agitated and aerated prior to use; bead-to-bead transfer; thawing, and media mixing. Custom Cellbags can be provided for the WAVE Bioreactor for any working volume between 100ml and 500 liters.
INSECT CELL/BACULOVIRUS The high oxygen supply capability of the WAVE Bioreactormakes it ideal for insect cell culture. Cell densities over9x106 cells/ml are routinely achieved.
Baculovirus yields are higher than with conventional bioreactors. The WAVE Bioreactor system is extremely easyto operate and inoculum scale-up and infection can bedone inside the bioreactor, reducing the need for transfers.
LitersSYSTEM 500/1000
100-500
PROVEN FOR: Insect Cell/BaculovirusPlant CultureCHOHELANS0Microbial
cGMP ProductionMicrocarriersPerfusion CultureMonoclonal AntibodiesYeast
T-CellsHEK293/AdenovirusPrimary Cell LinesProtein ExpressionVaccines
WAVEPOD INTEGRATED CONTROLLERThe new WAVEPOD instrument module integrates allinstrumentation associated with the WAVE Bioreactor:dissolved oxygen, pH, and CO2/O2 gas mixing controls.
Developed in response to customer demand, this unit combinesthese four key instruments, previously available as separatecontrollers, into a single, compact device. The WAVEPODconnects via a digital link to a WAVE Bioreactor BASE, and itslarge color touchscreen allows easy access to all parameters,including data from the bioreactor. By integrating all thecontrols associated with a bioreactor it is possible to developcomplex control schemes such as dissolved oxygen control byautomatically varying rocker speed or oxygen concentrationsupplied to the Cellbag. The WAVEPOD and WAVEBioreactor form a control cluster that can be accessedremotely over the built-in Ethernet interface for remote dataacquisition and supervisory control. The WAVEPOD isdesigned for use with WAVE Bioreactor System2/10EH andSystem20/50EHT.
Multiple POD configurations are available to meet individualcell culture needs, for insect cell, mammalian cell, perfusionor cell therapy applications. PODs are available with left- orright-facing probe connections for ease of use.
WAVE BIOREACTOR INSTRUMENT MODULES*CO2MIX Infrared CO2 sensor and aeration system providesa continuous supply of CO2 conditioned air to the Cellbag.
O2MIX Oxygen-air mixing controller provides continuoussupply of O2 enriched gas to the Cellbag for insect cell, virus,and high cell density applications. O2MIX can also be usedto maintain low-oxygen environment for near-anaerobicapplications.
DOOPT Unique optical dissolved oxygen monitor withminiature fiber-optic microprobes allow real-time measurementof dissolved oxygen. DOOPT is the only optical DO detectorresistant to photobleaching and ambient light, and capableof high accuracy measurement.
pH Enables continuous pH measurement and control usingCO2 or acid/base addition. Electrochemical probe is singleuse, and available pre-installed in Cellbags.
LOADCELL Module enables on-line measurement of weightand can be used for automated fill/harvest, and perfusionoperations whereprecise volumecontrol is critical.
*Instrument Modules are available in WAVEPOD or as standalone units for System2/10 &System20/50. Fully integrated modules are available for System200 & System500/1000.
Accessories
CELL CULTURE WAVE BIOREACTOR
WAVEPOD™
CONTROL MODULES
CO2 Gas MixingO2 Gas MixingOptical Dissolved OxygenpH Control
Touchscreen access to all parameters
FEATURES
Multiple configurations ofsensor/control modules:
pH, DOOPT, CO2 and O2pH, DOOPT and CO2DOOPT and O2DOOPT, CO and O2pH and CO2
Compact design
Allows for development ofcomplex control schemes
Ethernet port for dataacquisition
Autoswitching 110/220 VACoperation
pH and DO probes
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CUSTOM ENGINEERING
Custom systems can beengineered for specialapplications. For example,the CABINET20/50 shownhere can accommodatethree SYSTEM20/50units and all associatedinstrumentation in aspace-saving roll-arounddesign.
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WORKING VOLUMERANGE
INTEGRAL FEATURES
OPTIONS
WEIGHT
DIMENSIONS
UTILITIES
BASE 2/10EH
0.1 L – 5 L
Speed/Angle controlTemperature controlAeration
CO2MIXO2MIXDOPHPERFUSION CTRL
BASE 2/10EH
9 lbs (4.2 kg)
19 x 13.1 x 8 in(489 x 330 x 200 mm)
110/220 VAC
BASE 20/50EHT
0.1 L – 25 L
Speed/Angle controlTemperature control Aeration
WAVEPODCO2MIXO2MIXDOPHLOADCELLDUAL AIR/TEMP
BASE 20/50EHTa
34 lbs (15.5 kg)
22.6 x 18.3 x 7.1 in (573 x 465 x 179 mm)w/ KIT20:28 x 22.6 x 10 in (711 x 575 x 254 mm) w/ KIT50:30.5 x 27.6 x 10 in (775 x 700 x 254 mm)
100/240 VAC6/3 A 50/60Hz
BASE 200EH
5 L – 100 L
Speed/Angle controlTemperature controlAeration Loadcell
CO2MIXO2MIXDOPHDUAL AIR/TEMP
BASE 200EHb
780 lbs (350 kg)
73 x 43 x 44 in(185 x 110 x 112 cm)Unit can be tilted fortransportation
200-240 VAC50/60Hz 15A3-PhasePhase-Phase ±5%NEMA L2130 Plug
BASE 500/1000EH
50 L – 500 L
Speed/Angle controlTemperature controlAerationLoadcell
CO2MIXO2MIXDOPH
BASE 500/1000EHb,c
w/ KIT500:2000 lbs (925 kg) w/ KIT1000:2250 lbs (1020 kg)
79 x 49 x 63 in (201 x 124 x 160 cm)w/ KIT500:89 x 49 x 63 in (226 x 124 x 160 cm) w/ KIT1000:89 x 91 x 63 in (226 x 231 x 160 cm)
200–240 VAC 50/60 Hz, 30A3-PhasePhase-Phase ±5%NEMA L2130 Plug
Specifications
NOTES:
a – BASE20/50 requires selection of KIT20 or KIT50. KIT20 accommodates Cellbag2L, 10L, & 20L. KIT50 accommodates Cellbag22L & 50L.
b – Unit provided with casters.
c – BASE500/1000 requires selection of KIT500 or KIT1000. KIT500 accommodates Cellbag500L. KIT1000 accommodates Cellbag1000L.
Features
10
Cellbag bioreactor chambers are intended for single-use,and are suitable for cGMP production of human therapeutics.Cellbag components are similar to those used for biologicalstorage bags and meet USP Class VI specifications forplastics. Validation data and Cellbag DMF are available to demonstrate biocompatibility, however the user isadvised to validate suitability for specific applications.
FILM Cellbags are manufactured from multi-layer laminatedclear plastic films designed to provide high mechanicalstrength and bioinert fluid contact. Typically, the fluid contact layer is a medical grade low density polyethylene.The second or outer layer provides mechanical strengthand a gas-impermeable barrier. This non-contact layer is typically made of low density polyethylene, EVA or Nylon/EVOH copolymers. Other films for specialty applications are available.
STERILITY AND ENDOTOXINSterilized by gamma radiation at 25-40 kGy. Individual radiation indicators are affixed to each Cellbag. Lot radiation information provided. Each lot is tested for bacterial endotoxin. Lot release requires endotoxin below 0.125 EU/ml.
CUSTOMIZATIONCellbags can be readily customized for user-specified connectors, tube sets, and special components.
MECHANICAL STRENGTHFilm seal strength >67 N/cm. Each chamber is tested for leaks by pressure-hold test prior to sterilization.
CONNECTORS (TYPICAL)Air inlet 0.2 micron gas filter
Air outlet 0.2 micron gas filter with check valve
Sampling Needleless self-sealing syringe portNo laminar hood required
Fill/Harvest C-Flex™ tubing suitable for sterile fusing terminated with luer or MPC coupling
Multiuse Luer port with cap
Oxywell2TM Silicone sheath for DO probe
Many optional fittings such as pH probes, dip tubes, screw cap ports, temperature ports, perfusion filters, and special tubing ports are available.
BIOCOMPATIBILITY Testing is performed on irradiated film (50 kGy):
USP XXII plastic class VI and ISO 10993:
ISO 10993-4 Hemolysis study in vivo, extraction method
ISO 10993-5 Cytotoxicity study using ISO elution method
ISO 10993-6 Muscle implantation study in rabbit
ISO 10993-10 Acute intracutaneous reactivity study in rabbit
ISO 10993-11 Acute systemic toxicity in mouse
TEMPERATURE & PRESSURE RATINGCellbags may be used from 0°C to 50°C. Maximum operating pressure is 1.5 psig (0.1 bar).
Bioreactor Bags
CELL CULTURE CELLBAGS™
Outlet air filter
Inoculation/Harvestlines
Inlet air filter
Oxywell2
Needlelesssampling port
Spare luer port/optional pH probeCellbag rod
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Make Your Own Waves!
Add a filter, quick connect fitting or 10 feet of tubing – you decide! Disposable bioreactors can be easily customizedto suit your specific cell culture process needs for research,development or commercial manufacturing operations. Ourproduct specialists will work with you to create your ideal cell culture bag for use with the WAVE Bioreactor System.
The Wave Approach to MixingThe WAVE Mixer provides efficient mixing in a sealed bag by an innovative method. Instead of using a pump or
impeller to induce circulation flow, it uses waves generated by rocking motion. Wave motion moves large volumes
of fluid and disperses solids. The rocking motion is very efficient at generating waves because it essentially uses
gravity to accelerate the wave. The WAVE Mixer eliminates the need for a mixing tank and conventional mixer.
This also eliminates equipment cleaning, sterilization and validation.
12
FLUID
WAVE MIXER ™
MIXFLUIDS
13
14
WAVE MIXING THEORYThe WAVE Mixer makes it possible to mix materials contained in bags in a completely sterile manner. This special rocking platform induces a wave motion in the liquid without an impeller or other invasive mixer.The WAVE Mixer has been optimized for extremely efficient mixing and dispersion. Ten liters of liquid can be mixed to homogeneity in less than 7 seconds.
The M*Bag™ allows ingredients to be mixed and dissolved using the WAVE Mixer. The unique M*Bag is made of a multi-layer laminated clear plastic designed to provide high mechanical strength. A large screw capport allows powders or other solids to be easily pouredinto the bag. Probes to measure pH and conductivity can be inserted. A large outlet port allows the M*Bag to be drained completely.
SCALABLE TECHNOLOGYStandard systems are available for 20 liter and 50 literbags. These can be used to mix volumes from 1 to 35 litersof liquid. Larger systems up to 500 liters liquid volume areavailable. The WAVE Mixer principle has also been used forthe mixing of materials in custom-shaped rigid containers.
Features
Applications
MIXER20/50ET• In-process blending
• In-process pooling
• Blending for sampling
• Mixing prior to fill
• Reconstitution and dissolution
• In-process reactions
MIXER20/50EHT• Thawing of frozen materials
• Warming blood and other biological fluids
• Maintaining temperature duringpooling operations
MIX Let the Wave Mixer rock the M*Bag to mix and dissolve the ingredients
2 3M*Bag
1
INSTALL A NEW M*BAG ADD INGREDIENTS Simply pour in the ingredients through the large screw cap port
PUMP FILTER
S*Bag
FILTER STERILIZE Connect the M*Bag to the sterilizing filter and pump into the presterile receptacle
4
Up to15LitersMIXER20/50EHT + MIXKIT20
5
FLUID WAVE MIXER™
Up to 40LitersMIXER20/50EHT + MIXKIT50
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WORKING VOLUMERANGE
INTEGRAL FEATURES
OPTIONS
WEIGHT
DIMENSIONS
UTILITIES
MIXER20/50ETMIXER20/50EHT
1 L – 35 L
Speed/Angle controlTemperature control (EHT)
pHLOADCELL
MIXER20/50ETa
MIXER20/50EHTa
40 lbs (18 kg)
19.75 x 15 x 6.75 in(502 x 381 x 172 mm)w/ MIXKIT20:19.75 x 25.75 x 10 in (502 x 654 x 254 mm) w/ MIXKIT50:29 x 25 x 12 in (740 x 635 x 300 mm)
110/220 VAC, 10A
MIXER500/1000EMIXER500/1000EH
50 L – 500 L
Speed/Angle controlTemperature control (EHT)Loadcell
pH
MIXER500/1000Eb,c
MIXER500/1000EHb,c
w/MIXKIT500:2000 lbs (925 kg) w/MIXKIT1000:2250 lbs (1020 kg)
79 x 49 x 63 in (201 x 124 x 160 cm)w/ MIXKIT500:89 x 49 x 63 in(226 x 124 x 160 cm)w/ MIXKIT1000:89 x 91 x 63 in (226 x 231 x 160 cm )
208 - 240 VAC, 30A3-Phase
LOADCELL CONTROLLERAdds the capability to continuously weigh materials in themixing bag. This enables dispensing precise volumes whilerocking. Includes a 60kg capacity loadcell platform with 4 beam-type loadcells and controller. Installs in minutes. For use with MIXER20/50 models.
Features
Specifications
NOTES:
a – MIXER 20/50 requires selection of MIXKIT20 or MIXKIT50. MIXKIT20 accommodates M*BAG20L. MIXKIT50 accommodates M*BAG50L.
b - MIXER 500/1000 requires selection of MIXKIT500 or MIXKIT1000. MIXKIT500 accommodates M*BAG500L. MIXKIT1000 accommodates M*BAG1000L.
c – Unit provided with casters
Accessories
Safe and Rapid Fluid TransferThe Sterile Tube Fuser is a fully automated device for welding together thermoplastic tubing in a sterile operation
without the need for a laminar flow cabinet. The machine is useful for connecting tubing between sterile
containers, bioreactor bags, and process equipment. The unit can connect large diameter (up to 7/8 inch OD)
tubing for the rapid and safe transfer of large volumes. Major uses are bioprocessing, aseptic pharmaceutical
applications and final fill operations.
STERILE TUBE FUSERJOINED TUBING
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STERILE TUBE FUSER
6 8 11 13 16 19 220
1
2
3
4
5
6
1/4" OD5/16" OD
7/16" OD
1/2" OD
5/8" OD
3/4" OD
7
8
9
10
11
12
13
14
15
7/8" OD
* dr
y w
elds
on
ly
Large diameter tubing greatly increases the maximum flowrate that can be achievedmaking transfers of large volumes muchquicker. This graph shows the typicalflowrates possible with a peristaltic pumpusing tubing from 1/4" to 7/8" OD.
MA
X F
LOW
LIT
ER
S/M
IN
TU B I NG OD (mm)
• Sterile media transfer
• Vaccine manufacture
• Filling and formulation
• Bioreactors feed and harvest
• Pharmaceutical processfluid transfer
• High containment operations
• In-process pooling
• Transferring buffers
Applications
Insert a new blade and the tubing to be connected into the fuser and start the program1
The hot blade cuts the tubing and the cut ends are heldagainst the hot (>200°C) blade2
The machine slides the cut tubing into alignment alongthe hot blade ensuring sterile operation3
The blade moves out and the tubing ends are fusedtogether to form a welded connection4
Features How It WorksSTF-IRc
TUBING OD RANGE 0.25 – 0.875 in(6.4 – 22.2 mm)
TUBING CONDITION Dry thermoplastic
FUSING CYCLE 2 – 3 minutes
OPTIONS Thermal PrinterTUBE1-IR (0.625 in/15.5 mm)TUBE2-IR (0.75 in/19.1 mm)TUBE3-IR (0.4375 in/11.2 mm)TUBE4-IR (0.25 in/6.4 mm)TUBE5-IR (0.3125 in/8 mm)TUBE6-IR (0.375 in/9.6 mm)TUBE7-IR (0.50 in/12.5 mm)TUBE8-IR (0.875 in/22.2 mm)
STF-IRcWEIGHT 35 lbs (16 kg)
DIMENSIONS 15.5 x 14 x 10.4 in(395 x 355 x 265 mm)
UTILITIES 110/220 VAC, 1A
Specifications
19
HOT LIPS TUBE SEALER
Applications
• Sealing tubing attached to bags
• Tamperproof sealing
• Sampling
• Shipping/storage
• Sealing transfer/sampling lines
1-1/4" 1/4"
TUBING OD
Specifications
WEIGHT 18 lbs (8 kg)
DIMENSIONS 14 x 6.5 x 8 in(356 x 165 x 203 mm)
UTILITIES 110/220 VAC, 1A
The tubing to be sealed is placed in the jaws. Push button to closejaws to a preset distance based on type and size1
Jaws heat to melt tubing2
Jaws push together to form the seal3
Fans cool the seal. Jaws open once seal is cool. The entire operationis performed by a sophisticated motion control system capable of0.01 mm positioning accuracy
4
Features
TUBING OD RANGE 0.25 – 1.25 in(6.4 – 31.8 mm)
TUBING CONDITION Dry or fluid-filled thermoplastic
FUSING CYCLE Approx. 2 minutes
How It Works
“The Pipeless Plant” is a reality!The biopharma industry has embraced the use of single-use systems in pilot plant operations as well as in commercial
production of approved therapeutics over the last decade. Disposables can be easily integrated as individual process
steps in existing stainless-steel operations, or as an entire production platform. Disposable bioreactors, mixers, tube
welders & sealers, allow users to configure facilities using disposables exclusively.
From scalable, customizable bioreactors & mixers, to integrated, single-use sensors, to tube welders & sealers,
WAVE products provide an integrated solution for rapid, efficient & reliable bioprocessing.
DISPOSABLE BIOPROCESSING
MEDIA & BUFFER PREP
STERILE FLUID TRANSFERTUBE WELDING & SEALING
INOCULUM PROPAGATION
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INTEGRATELARGE SCALE CELL CULTURE OPERATIONS
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STERILE FLUID TRANSFERTUBE WELDING & SEALING
The WAVE Products Group understands the need for prompt, reliable service in today’s research & development
labs, pilot plants & cGMP production environments. Our service engineers are factory-trained and have the
experience to install your instruments and maintain them in peak condition. We offer a range of support services
through GE Healthcare LabCrew Service to match your needs, including Preventive Maintenance, On-Site and/or
Mail-In Service Agreements, Operational Training and Time and Material Services.
SUPPORT &
TRAINING
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MAINTENANCE &
SERVICE
Preventive Maintenance is critical to instrument uptime and your success. Varying laboratory environments, daily
usage and multiple users can all affect instrument performance. We recommend an annual PM to ensure your
instruments are running at optimal performance, and to identify and fix problems before they result in process
downtime. Unlike some preventive maintenance plans, we offer Preventive Maintenance including full calibration of
all relevant instrument components and any necessary software upgrades. GE Healthcare LabcrewTM Instrument
Service offers a range of support services, tailored to your service needs.
SUPPORT
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INSTALLATIONInstallation by factory-trained service engineers is offered on our larger WAVE Bioreactors such as the System200 and System500/1000. Installation includes pre-installationinspection, set-up and a full system check utilizing theinstrument’s “Startup Checklist.” Installation is also availablefor the smaller System20/50 for complex installations, multiple unit purchases, or purchases requiring high-levelbioreactor control strategies.
WAVE Product Group offers both FAT (Factory AcceptanceTest) and SWT (Site Warranty Test) services for the WAVEBioreactor to assist our customers with installation, validation activities & regulatory compliance. Please contactyour Sales Representative or our LabCrew ServiceDepartment for further details on FAT and SWT services.
TRAININGGEHC Fast TrakTM Training Courses include a theory andoperational session on the disposable bioreactor. We alsooffer an in-depth, hands-on cell culture course throughPacificGMP in San Diego, CA. This WAVE DisposableBioProcessing Training Program is a two and a half dayprogram focused on creating expert-level WAVE Bioreactorusers. The course is centered on implementing disposableprocesses, scale-up, perfusion and ease of fluid transfers.Visit our website for additional information & currentcourse dates. Please contact your local Sales Specialist or Customer Service for further information about any ofour Training Programs.
SUPPORT
Installation & Training
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SERVICE AGREEMENTSWe offer a range of support services, tailored to your serv-ice needs.
Service Agreements offer:• Peace of mind• Total control over maintenance costs• Assistance in meeting regulatory requirements• Priority service response
Gold Service Agreement: Full instrument coverage of electrical and mechanical assemblies, should emergencyservice be required, for the duration of the agreement.Includes one annual Preventive Maintenance visit. Includesall covered replacement parts, labor, and travel. GoldService customers also enjoy priority response.
Silver Service Agreement: Full instrument coverage of electrical and mechanical assemblies, should emergencyservice be required, for the duration of the agreement.Includes all covered replacement parts, labor, and travel.Silver Service customers also enjoy priority response.
Field Preventive Maintenance: Annually scheduled fieldservice following a customized maintenance procedure,including calibration. Includes PM parts, labor and travel.
Bronze Plus Service Agreement: Full instrument coverage ofelectrical and mechanical assemblies, should emergencyservice be required, for the duration of the agreement.Includes one annual PM. Instruments to be serviced onlyat Labcrew facilities worldwide. Includes all coveredreplacement parts and labor. Customer to bear cost ofshipping to GE Healthcare; GEHC will bear return shipping costs.
Mail-In Preventive Maintenance: Scheduled service at customer-requested time interval following a customizedmaintenance procedure, including calibration. Includes PM parts and labor. PM will be performed only at Labcrewfacilities worldwide. Customer pays for shipping to GEHealthcare; GEHC will bear return shipping costs.
TIME AND MATERIAL SERVICEWe offer the same quality service for those customers whowish to maintain their instruments on a time and material basis. Call us with the model name and serialnumber of your instrument and we will be glad to processyour service request.
Please call our Labcrew Service Specialist to learn more about service agreements.
Maintenance & Service
INSPIRE.
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WAVE PRODUCTS GROUP
Learning CenterY
The nation’s first hands-on disposable bioprocessing training program. Featuring the latest WAVE equipment, we are now offering practical instruction and hands-on production experience in the set-up, the transition to and the use of disposable bioprocessing systems.
Register online at www.gelifesciences.com/wave
Wave Biotech was founded by Dr. Vijay Singh, a recognized authority on large-scale cell culture and fluid mixing. Dr. Singh is the author
of many technical papers and the holder of several US patents. He has been involved with the design and operation of bioreactors
since 1980. The concept of wave-induced agitation for fluid mixing and oxygenation in inflated plastic bags was pioneered by him
in 1995 as a replacement for expensive and labor-intensive stirred tank bioreactors. This concept was developed into what is now
known as the WAVE Bioreactor, hundreds of which have been sold since introduction in 1996. Technical innovations include the
development of bags with internal filters patented for perfusion and the scale up to culture volumes over 500 liters. Spinoffs of the
technology include WAVE Mixers which provide non-invasive sterile mixing, heating for thawing applications, and a host of
instrumentation suitable for introduction into disposable bags. In April, 2007, WAVE was acquired by GE Healthcare. The
combination of GE Healthcare and Wave Biotech will allow for future expansion into new applications and creation of a broad
offering of added value tools and services for the biopharmaceutical marketplace.
WAVE BIOTECH
OUR HISTORYY
Vijay Singh, Ph.D
“A whole new generation of
drugs will evolve from our
increased knowledge and skills
in understanding the genetic
basis for disease. Disposable
cell culture will play a
dominant role in providing
cost-effective therapies.”
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cGMP PRODUCTION
NS0
INSECT CELL/BACULOVIRUS
PERFUSION CULTURE PLANT CELLSHEK293/ADENOVIRUS
CELL THERAPY
HELA
INOCULUM PROPAGATION
MONOCLONAL ANTIBODIES
PROTEIN EXPRESSIONCHO
PLANT CULTUREVACCINES
MICROCARRIERS
WAVE Bioreactor, Cellbag, WAVE Mixer, Hot Lips Tube Sealer, M*BAG, WAVEPOD, Oxywell, Fast Trak and Labcrew are registered trademarks of GE Healthcare Companies
GE Healthcare Bioscience BioProcess Corp.800 Centennial AvenuePiscataway, NJ 08855-1327 USA
Toll free (800) 526-3593Tel (732) 457-8000Fax (732) [email protected]
www .wavebiotech.com www.gelifesciences.com/wave
28-9282-57 ABRev August 2008
Wave Biotech, LLC is now part of GE Healthcare Life Sciences.
