pall,颇尔,Cadence Inline Concentrator,ILD010T010407, ILD010T020407, ILD010T120407, ILD010T060407, ILD030T010407, ILD030T020407, ILD030T120407, ILD030T060407

pall,颇尔,Cadence Inline Concentrator

The Cadence Inline Concentrator simplifies concentrating solutions of biomolecules to an in-line and ready-to-use process.The recirculation loop associated with tangential flow filtration (TFF) conventionally used for this process is eliminated.Pump and tube sizes are reduced, product recovery is maximized, and sensitive proteins are exposed to less shear.The Cadence Inline Concentrator moves the product being processed through a proprietary design flow path in a pre-assembled module with all connections already in place and designed to couple to available standard tubing manifolds.

Typical applications include monoclonal antibodies, fractionated antibodies, recombinant proteins, other proteins and recombinant blood factors.The Cadence Inline Concentrator is used to concentrate clarified bulk after fermentation, and to reduce the number or size of bags needed and increase product concentration to improve chromatography performance.

Cost projections with BioSolve* software show that, compared to conventional single-use TFF, the Cadence Inline Concentrator provides a 31% cost of goods sold and a 66% capital investment savings per batch because of the elimination of the need for intermediate tanks, ability to use smaller chromatography columns, energy savings, and the ability to couple processes to reduce downtime.

特色及优点

Unique design enables Single-Pass TFF

In Tangential Flow Filtration (TFF), also known as Crossflow Filtration, liquid is pumped across the membrane surface, minimizing fouling by sweeping retained molecules off the surface.在回流中对膜形成压力，从而使溶质和小分子通过膜以实现过滤。Multiple passes are normally needed to achieve the required level of concentration and this is accomplished in conventional TFF by initially filling a tank with solution and recirculating retentate into the tank after each pass through the membrane cassette to gradually increase its concentration.



The Inline Concentrator delivers the required concentration in a single-pass through the device

The Inline Concentrator, on the other hand, is delivered as module with a series of cassettes in series.Retentate from the first cassette is cycled through a staged flow path consisting of multiple cassettes so that a single-pass through the device delivers the final concentration level.This approach eliminates the need to accumulate a batch in a tank.

Advantages of inline concentrator

• In-process volume reduction provided by the inline concentrator reduces the cost of chromatography steps and helps increase throughput from existing tank volume and floor space.
• The single-pass TFF process substantially reduces exposure to shear, stress and foaming, making it ideal for fragile molecules such as monoclonal antibodies.
• Capital investment and installation time are reduced because Cadence Inline Concentrator modules are provided as assembled units that do not require a holder.
• The Inline Concentrator is designed for one-time use, eliminating the expense of cleaning and cleaning validation, one of the major cost factors involved in re-use operations.
• Elimination of recirculation enables 5-10X lower feed flow rate and 2-3X smaller line sizes which allows a more compact or smaller set-up with minimized hold-up volume, contributing to higher product recovery.

* The BioSolve Platform helps clients make well informed decisions quickly, saving time and resources during the development and manufacture of cost effective medicines.www.biopharmservices.com

Volume Reduction

Based on the application the Cadence Inline Concentrator with a Delta 10 or 30 kD membrane can increase the volumetric concentration factor by 2 – 5 x

Product Recovery

Testing shows that the Cadence Inline Concentrator provides 99+% product recovery after processing with just one system volume flush.

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 Service Group is available to assist in conducting trials to select configurations and develop operating conditions necessary to achieve the desired process objectives.

材料成分

Cassette: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 platinuum cured silicone
• T01/T02 - female luer connection and cap:聚丙烯
• T12 - MPC quick disconnect connector and plug:聚砜

Operating Limits

Maximum 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

T01:120 – 295 LMH (0.13 – 0.32 L/min)
T02:138 – 295 LMH (0.30 – 0.64 L/min)
T12:150 – 318 LMH (1.80 – 3.70 L/min)
LMH = Liters/meter²/hour

Module Integrity Test

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 Inline Concentrator packaged in preservative is expected to be 2 years from the date of manufacture when the modules are stored unopened in the original packaging at temperature up to 25 °C and protected from direct light.Extended shelf life studies are ongoing.

Biological Safety

Materials of construction for Cadence Inline Concentrator 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 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 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 Inline Concentrators

颇尔 Provides Comprehensive Documentation with Each Cadence Module

图 2

Cadence Inline Concentrator Concentration Factor vs.Permeate Flux at Various IgG Feed Concentrations (2, 10 and 58 g/L) and Various Feed Pressures (20 – 60 psig)

图 3

Cadence Inline Concentrator Case Study.~10 g/L IgG Processing with Delta 30 kD, T01 (0.065 m²) Module

*Data generated during in-house studies utilizing R&D prototype modules

 

Identify and order Cadence Inline Concentrator using the table below.For example, a T01 module with 10 kD Delta regenerated cellulose membrane area of 0.065 m2 (0.006 ft2) is part number CD010T010407.

Guide to Cadence Inline Concentrator Module Part Numbers

IL Inline concentrator
D Delta regenerated cellulose membrane
010 Nominal molecular weight cut-off
T01 Cassette format
04 Number in series
07 Number of cassettes
例如：Part number CD010T010407

Cadence Inline Concentrator Part Number and Membrane Area (m²)

Part Number	Cadence Inline Concentrator	Number in Series	Membrane Area [m2]	MWCO [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

pall,颇尔,Cadence Inline Concentrator