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Cadence™ Inline Concentrator
Delta 10 kD and 30 kD Regenerated Cellulose Membrane
Single-pass TFF made simpler Single-pass tangential flow filtration (TFF) is revolutionizing how TFF is implemented in biotech, vaccine,blood plasma and other applications. Pall is now making it even easier to implement this breakthroughpatented technology into your process. As with the original Cadence single-pass TFF module, the newCadence Inline Concentrator allows direct flow-through in-process volume reduction and can beimplemented into an existing process system or operate as a stand alone unit.
This exciting new technology leads to economic and practical benefits, including:Potential reduction of product damage or aggregation due to reduced residence time and shear exposure.
Ability to couple the concentration of product before or after other downstream process steps, consequently optimizing other steps and reducing in-process pool tank volumes.
Elimination of cleaning requirements.
Easy integration of the assembled module, allowing plug and play.
The preassembled modules do not need a holder. A tubing set is available to connect the ports to a pressurized feed source and the appropriate outlets. Once the feed port is connected to a pressurizedfeed source, the module is ready for use. The built-in resistor in the retentate manifold eliminates the need for downstream instrumentation and allows volume reduction of 2 to 4X (or higher), depending on the application.
Using Cadence Inline Concentrator with Delta membrane, the innovative benefits of single-pass TFF technology are enhanced by the proven high flux, high selectivity, and low protein binding attributes of Delta regenerated cellulose membrane.
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Optimize Economic and Operational Benefits Enhance downstream processing to increase capacity and reduce costs – Cadence Inline Concentrator modules canhelp to eliminate or reduce the size of intermediate storage tanksand associated cleaning of tanks when used for in-process volume reduction before or after existing steps.
Enable in-process volume reduction – Depending on the initial concentration and product characteristics, a volume reduction of 2 to 4X (or higher) can be achieved with minimal instrumentation or system.
Optimize processing of highly shear-sensitive products –Processing results in only one pass through the pump and module, reducing shear exposure. For products sensitive topumping, the pump can be completely eliminated by using pressurized vessels to flow the process fluid through the module. Further benefits are achieved by eliminating any mixing or foaming issues associated with the feed tank.
No holder required – Cadence Inline Concentrator modulesare provided assembled, and the cassettes and manifolds arepre-torqued between two end plates so that no extra holder isrequired. Benefits include:
Easy connection to a pressure source, like a pump or pressure vessel
Simplified in-process volume reduction
The module feed, retentate and permeate ports are easily connected to the appropriate outlets using clearlymarked ports
Product PlatformInnovative single-pass TFF processing takes place within theCadence SPTFF modules. Cadence SPTFF modules incorporatePall’s proven T-Series cassettes with Delta membrane, and areavailable in different formats to accommodate various processingvolumes (see Ordering Information).
Figure 1Cadence Inline Concentrator Modules
T-Series Cassettes with Delta MembraneDelta regenerated cellulose membrane offers high flux andselectivity. The membrane has been specifically developed tominimize protein binding to the surface and interstitial structureof the membrane. Inherently hydrophilic, this membrane showslow protein adsorption properties and is optimal for processesinvolving very hydrophilic proteins.
Delta regenerated cellulose membrane shows low foulingcharacteristics, allowing consistent performance.
ApplicationsThe Cadence Inline Concentrator is designed for in-processvolume reduction in various steps in a wide range of applicationsin the biopharmaceutical industry including recovery of antibodiesor recombinant proteins and preparation of samples (concentrating,desalting) before or after column chromatography and can be implemented in existing facilities facing tank capacity issuesor to optimize existing processes.
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SpecificationsThe operating conditions and module configurations for anysingle-pass TFF process must be established by performingtrials and analyzing results. Pall’s Technical Service Group isavailable to assist in conducting trials to select configurationsand develop operating conditions necessary to achieve thedesired process objectives.
Materials of ConstructionCassette: Delta regenerated cellulose membrane, 10 kD or 30 kD with polypropylene screen, white polyurethane encapsulant with white pigment (TiO2), and medical grade silicone for the permeate seals
Gaskets: Medical grade, platinum cured silicone
Manifold Plates: UHMW polyethylene
Tubing and Connectors:• Tubing - pharmaceutical grade platinum cured silicone• T01/T02 - female luer connection and cap: Polypropylene • T12 - MPC quick disconnect connector and plug: Polysulfone• T06 - MPX quick disconnect connector and plug: Polysulfone
Operating LimitsMaximum Pressure: 4.1 barg (60 psig)
Maximum Transmembrane Pressure (TMP): 4.1 barg (60 psig)
Processing Temperature Range: 4 – 40 °C(freezing will damage module)
pH Range: 2 – 13
Typical Feed Flow Rates JFEED, DIW [LMH]
ILC Area (20-60 psig) QFEEDModules (m2) Low High (L/min)
T01 0.065 80 300 0.1 - 0.3
T02 0.13 0.2 - 0.7
T12 0.7 0.9 - 3.5
T06 3.5 4.7 - 17.5
Module Integrity TestModule Integrity Test Pressure: 4.1 barg (60 psig)
Acceptable Forward Flow Rate: < 50 sccm/ft2 (538 sccm/m2)
Each Cadence module has a unique serial number for full traceability.
Shelf LifeThe shelf life of Cadence Inline Concentrator packaged in preservative is expected to be 1 year from the date of manufacture when the modules are stored unopened in the original packaging at temperature up to 25 °C and protectedfrom direct light. Extended shelf life studies are ongoing.
Biological SafetyMaterials of construction for Cadence Inline Concentrator modules have been tested and meet the requirements for the Biological Reactivity Tests listed in the United StatesPharmacopeia (USP) under USP <88> for Class VI - 70 °CPlastics.
DocumentationEach module is supplied with the following comprehensive documentation to ensure the Cadence Inline Concentrator module is operated successfully:
Certificate of Quality
Care and Use Procedures
Material Safety Data Sheet for the Module Preservative Solution
Contact your local Pall representative to obtain:Validation Guide
Validation Service for specific tests such as compatibilitytesting with your product fluid
Training and Technical Support to optimize your process usingCadence Inline Concentrators
Pall Provides Comprehensive Documentation with eachCadence Module
PerformanceFigure 2Cadence Inline Concentrator Concentration Factor vs. PermeateFlux at Polyclonal Bovine IgG Feed Concentrations of 2 and 10 g/L over Various Feed Pressures (20 – 60 psig)
Figure 3Case Study: 2 g/L Polyclonal Bovine IgG Processing with Delta30 kD, T01 (0.065 sqm.) Module
Figure 4Case Study: 5 g/L Polyclonal Bovine IgG Processing with Delta10 kD, T06 (3.5 sqm.) Module
Ordering InformationIdentify and order Cadence Inline Concentrator using the tablebelow. For example, a T01 module with 10 kD Deltaregenerated cellulose membrane area of 0.065 m2 (0.7 ft2) is part number ILD010T010407.
Guide to Cadence Inline Concentrator Module Part Numbers
IL Inline concentratorD Delta regenerated cellulose membrane 010 Nominal molecular weight cut-offT01 Cassette format04 Number in series07 Number of cassettesExample: Part number ILD010T010407
Cadence Inline Concentrator Part Number andMembrane Area (m2)
Cadence Part Inline Number in Membrane MWCO Number Concentrator Series Area [m2] [kD]
ILD010T010407 T01 4 0.065 10
ILD010T020407 T02 4 0.13 10
ILD010T120407 T12 4 0.7 10
ILD010T060407 T06 4 3.5 10
ILD030T010407 T01 4 0.065 30
ILD030T020407 T02 4 0.13 30
ILD030T120407 T12 4 0.7 30
ILD030T060407 T06 4 3.5 30
Corporate HeadquartersPort Washington, NY, USA+1.800.717.7255 toll free (USA)+1.516.484.5400 [email protected] e-mail
European HeadquartersFribourg, Switzerland+41 (0)26 350 53 00 [email protected] e-mail
Asia-Pacific HeadquartersSingapore+65 6389 6500 [email protected] e-mail
International OfficesPall 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, andVietnam. Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit www.pall.com/contact.
The information provided in this literature was reviewed for accuracy at the time of publi-cation. Product data may be subject to change without notice. For current informationconsult your local Pall distributor or contact Pall directly.
© 2014, Pall Corporation. Pall, , and Cadence are trademarks of Pall Corporation. ® indicates atrademark registered in the USA and TM indicates a common law trademark. Filtration. Separation.Solution. is a service mark of Pall Corporation.
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Visit us on the Web at www.pall.com/biopharmE-mail us at [email protected]
