pall,颇尔,Cadence 单向流切向流过滤组件和系统,CD010T010815

产品名称:
Cadence 单向流切向流过滤组件和系统
产品型号:
CD010T010815
产品描述:

产品介绍

pall,颇尔,Cadence 单向流切向流过滤组件和系统,CD010T010815
pall,颇尔,Cadence 单向流切向流过滤组件和系统

Cadence 单向流切向流过滤组件和系统

Eliminate the Recirculation Loop and Streamline Operations to Optimize Downstream Processing

Cadence Single-Pass TFF ( SPTFF ) is a patented breakthrough technology that allows direct flow-through concentration with no recirculation of product.SPTFF enables high concentration of shear sensitive proteins and antibodies >160 grams/liter.What makes this possible is a unique flow path design and staging of cassettes in a serial flow.

See the Cadence™ system in action, watch the video.

Single-pass TFF patent numbers:

  • See the Cadence™ system in actionUS patent number 7.682.511 B2
  • US patent number 7.384.549 B2
  • US patent number 7.967.987 B2
  • US patent number 8.157.999

This exciting new technology leads to
economic and practical benefits, including:

  • Increased yield of product due to improved recovery capability and lower hold-up volume.
  • Increased final product concentration due to high concentration factor capability.
  • Elimination 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.
  • Available in single use format.

Cadence single-pass TFF modules and systems can be easily integrated with other downstream processes such as chromatography or virus removal. 

Using Cadence modules 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 cassettes.

Optimize Economic and Operational Benefits

  • Enhance downstream processing to increase capacity and reduce costs – Cadence systems can eliminate or reduce intermediate storage tanks and associated cleaning of tanks when using the systems for in-process volume reduction before or after existing steps.
  • Increase yield and achieve high product recovery > 98 % – The single-pass TFF process collects most of the process volume during the process run, leaving only a small percentage of the product in the module at the end of the run.This small percentage of product can be easily recovered due to the low hold-up volume in the system.
  • Enable high concentration factors > 20X – High concentration factors are achieved due to the staging of cassettes in series, which results in high conversions of feed-to-permeate in one flow path.This is accomplished by optimizing the module staging configuration based on cassette performance for a particular application.
  • Optimize processing of highly shear-sensitive products – Processing results in only one pass through the pump and cassette, reducing shear exposure.For products sensitive to pumping, 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.
  • Use smaller, more compact systems – Cadence systems require less pump capacity, allowing smaller piping or tubing diameters for a more compact system design with lower working and hold-up volumes.
  • Simplify installation and use – Cadence modules are supplied preassembled.The modules’ feed, retentate and permeate ports are easily connected to clearly-marked system ports.

Product Platform

Innovative single-pass TFF processing takes place within Cadence modules.Cadence modules incorporate 颇尔’s proven T-Series cassettes with Delta membrane, and are available in different sizes to accommodate various processing volumes (see Ordering Information).Cadence modules are designed for use with a 颇尔 Cadence single-pass TFF system.(Contact 颇尔 for information on a Cadence system to meet your application requirements.)

Cadence Modules Incorporate High Performance T-Series Cassettes with Delta Membrane

Delta 再生纤维素膜可提供高流量和选择性。这些专门研发的膜可最大程度地降低表面蛋白质结合以及膜的填隙结构。这类亲水性膜显示了低蛋白质吸附特征,是涉及亲水性蛋白质工艺的理想选择。Delta regenerated cellulose membrane shows low fouling characteristics, allowing consistent performance or flux from run to run.It is easy to clean and typically recovers normalized water permeability (NWP) by using 0.1 N NaOH.

Cadence T01 Module Installed in Holder

 
 
Cadence single-pass TFF modules and systems are used tconcentrate biomolecules.They alscan be used for salt-level reduction by concentrating followed by in-line dilution.Volume capacities range from several liters tthousands of liters.Single-pass TFF may be used tperform various steps in a wide range of applications in the biopharmaceutical industry, including:
  • In-process volume reduction
  • Desalting protein solutions
  • 抗体或重组蛋白的纯化和回收
  • Preparation of samples (concentrating, desalting) before or after column chromatography

Single-Use Applications

Depending on the application, Cadence modules may alsbe applied for single use.When applied for single use, Cadence modules are used with a specially-designed Cadence system.Contact 颇尔 for more information on single-use systems.

应用说明:Cadence™ Systems Employ New Single-Pass TFF Technology tSimplify Processes and Lower Costs
  • The commercialization of a revolutionary TFF technology by 颇尔 Life Sciences presents opportunities tsimplify biopharmaceutical process design and lower capital and operational costs.The new technology, single-pass TFF, is brought tlife through 颇尔’s Cadence systems and modules.This Application Note introduces the design innovations of Cadence single-pass TFF systems tbiopharmaceutical researchers and manufacturers.
Protein Concentration with Single-Pass Tangential Flow Filtration (SPTFF):This peer-reviewed journal article on the Cadence Single-Pass Tangential Flow Filtration (SPTFF) technology has been published in the Journal of Membrane Science (Volume 384, Issues 1-2, 2011, pp 82-88).The article highlights the novel SPTFF process including:
  • SPTFF process is continuous, produces high concentration factors, significantly higher conversion in one pass through flow rating control and eliminates the need for the conventional recirculation loop.
  • Elimination of the conventional recirculation loop minimizes aggregation problems and requires no mixing, minimizes shear exposure and also alows the SPTFF step to be coupled with other downstream process steps.
  • Additional SPTFF benefits over conventional TFF include lower system hold-up volumes, higher recoveries, and lower flush volume requirements.
  • Applications that can leverage SPTFF technology include but are not limited tin-process volume reduction, inline salt reduction, high-concentration formulations, and processing of fragile biomolecules.
 

The operating conditions and module configurations for any single-pass TFF process must be established by performing trials and analyzing results.颇尔’s Technical Support Group is available to assist in conducting trials to select configurations and develop operating conditions necessary to achieve the desired process objectives.

 

Cadence Module Materials of Construction

  
Delta regenerated cellulose, 10 kD and 30 kD
支持 聚丙烯
Screens 聚丙烯
Encapsulant Polyurethane with white pigment (TiO2)
Permeate Seals Medical grade, platinum cured silicone
Gaskets Medical grade, platinum cured silicone
 
 
Cadence Module Operating Limits   
Maximum Pressure 6 barg (87 psig) @ 23 °C
4.1 barg (60 psig) @ 55 °C
Maximum Transmembrane Pressure (TMP) 4.1 barg (60 psig) @ 4 - 55 °C
Processing Temperature Range 4 to 40 °C (freezing will damage module)
pH 范围 2 至 13
Flow Rate Range During Cleaning < 5 L/min/m2
(0.2 L/min/ft2)
 

The performance of Cadence modules, based on an IgG model feed solution, is demonstrated in the table below over a wide range of feed flow rates (L/min/m2) and volumetric concentration factors (X) for various module configurations and feed concentrations (g/L).

 
Cadence Module Typical Feed Flow Rates in L/min/m2 浓缩倍数
Process Flux* 4X 10X 30X
10 LMH 0.22 0.19 0.17
50 LMH 1.11 0.93 0.86
100 LMH 2.22 1.85 1.72
 

* LMH = Liters/meter2/hour

 
Cadence Module Integrity Test  
Systems Integrity Test Pressure 4.1 barg (60 psig)
Acceptable Pressure Decay (System) < 0.07 barg (1 psig) per minute
Module 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 Life

The shelf life of Cadence modules packaged in preservative is expected to be two years from the date of manufacture when the modules are stored unopened in the original packaging at ambient temperature up to 25 °C and protected from direct light.Extended shelf life studies are ongoing.

Biological Safety

Materials of construction for Cadence modules have been tested and meet the requirements for the Biological Reactivity Tests listed in the United States Pharmacopeia (USP) under USP <88> for Class VI - 70 °C Plastics.

文件材料

Each module is supplied with the following comprehensive documentation to ensure the Cadence module is operated successfully:

  • Certificate of Quality
  • Care and Use Procedures
  • Material Safety Data Sheet for the module preservative

Contact your local 颇尔 representative to obtain:

  • 验证指南
  • Validation service for specific tests such as compatibility testing with your product fluid
  • Training and technical support to optimize your process using Cadence systems

颇尔 Provides Comprehensive Documentation with Each Cadence Module

 
 

Achieve High Concentration Factors:
Flux Versus Concentration for Cadence Modules with Delta 30 kD Membrane
MAb Material (53.2 g/L Initial Concentration)

 

Identify

and order Cadence modules using the table below.For example, a Cadence T01 module with 10 kD Delta regenerated cellulose membrane area of 0.14 m2 (1.5 ft2) is part number CD010T010815.注意事项:a 颇尔 Cadence system must be used to operate Cadence modules.(Contact 颇尔 for information on a Cadence system to meet your application requirements.)

 

Guide to Cadence Module Part Numbers

例如:Part number CD010T010815

 
C D 010 T01 08 15
浓缩 Delta membrane Nominal molecular weight cutoff (10 kD) Cassette format Number of cassettes in series Total number of cassettes in module
 

 

 
Cadence 膜柱 Configuration Delta 10 kD Membrane Area (m2) Part Number
T01 4-in-series 0.065 CD 010 T010407
T01 7-in-series 0.12

CD 010 T010713

T01 8-in-series 0.14 CD 010 T010815
T01 9-in-series 0.17

CD 010 T010918

T02 4-in-series 0.13

CD 010 T020407

T02 7-in-series 0.24

CD 010 T020713

T02 8-in-series 0.28 CD 010 T020815
T02 9-in-series 0.33 CD 010 T020918
T12 4-in-series 0.7 CD 010 T120407
T12 7-in-series 1.3

CD 010 T120713

T12 8-in-series 1.5

CD 010 T120815

T12 9-in-series 1.8 CD 010 T120918
T06 4-in-series 3.5 CD 010 T060407
T06 7-in-series 6.5 CD 010 T060713
T06 8-in-series 7.5 CD 010 T060815
T06 9-in-series 9.0 CD 010 T060918
Cadence 膜柱 Configuration Delta 30 kD Membrane Area (m2) Part Number
T01 4-in-series 0.065 CD 030 T010407
T01 7-in-series 0.12

CD 030 T010713

T01 8-in-series         0.14 CD 030 T010815
T01 9-in-series 0.17

CD 030 T010918

T02 4-in-series 0.13

CD 030 T020407

T02 7-in-series 0.24

CD 030 T020713

T02 8-in-series         0.28 CD 030 T020815           
T02 9-in-series 0.33 CD 030 T020918         
T12 4-in-series 0.7 CD 030 T120407
T12 7-in-series 1.3

CD 030 T120713

T12 8-in-series         1.5

CD 030 T120815

T12 9-in-series 1.8 CD 030 T120918
T06 4-in-series 3.5 CD 030 T060407
T06 7-in-series 6.5 CD 030 T060713
T06 8-in-series 7.5 CD 030 T060815
T06 9-in-series 9.0 CD 030 T060918
 

 


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