Cadence™ BioSMB PD System product photo Primary L

Cadence™ BioSMB PD System

Continuous Single-Use,
Multi-Column Chromatography

Pall’s Cadence BioSMB platform is the first disposable flow path, continuous multi-column chromatography solution that is fully scalable from the Process Development (PD) laboratory to GMP manufacturing. The BioSMB system is specifically designed to allow users to convert an existing batch process into a continuous chromatography step without changing the chromatographic sorbent, buffer system or product quality assays. BioSMB technology provides process consistency across all scales – development, clinical and full production – and is also practical to implement in flexible, multi-product facilities.

  • Inherent unit operation efficiency of the Cadence BioSMB PD system reduces the cost of chromatographic media by up to 80% without changing either the sorbent or buffer used in the chromatographic process.
  • Entire chromatographic process can be conducted in a smaller system containing a fraction of the media and buffer that would be required in a standard batch process to produce the same amount of material.
  • Ability to use up to 16 columns increases specific productivity and application flexibility. Position of the buffer selection valve eliminates composition gradients and wash steps.

Benefits

Batch chromatographic processing typically utilizes only 50% to 70% of the chromatographic column’s total binding capacity. The Cadence BioSMB PD system, on the other hand, uses a series of substantially smaller, interconnected columns. The first column in the load zone is allowed to reach breakthrough and the product breakthrough is captured on a second column. The binding capacity of the first column can thus be exploited well beyond its batch dynamic binding capacity. In many cases, such processes can be operated close to the equilibrium or static binding capacity of the chromatographic media, thus leading to a significant reduction in chromatographic media use.

The Cadence BioSMB PD system use of continuous countercurrent loading means that the load zone must accommodate only the mass transfer zone, which generally represents a small percentage of a batch column. This allows the entire process to be conducted in a much smaller system carrying only a fraction of the chromatography media used in a standard batch process. When used in larger scale applications, BioSMB technology can eliminate the need for packing skids, large stainless steel columns, and other support infrastructure. This results in a smaller overall footprint and a more scalable configuration.

While competitive systems use a complex set of valves, the Pall BioSMB technology uses an integrated valve cassette specially designed and patented as a single-use component. The new valve system eliminates the need for a difficult cleaning validation process.

The ability to use up to 16 columns with Cadence BioSMB PD system means that it supports the broader application base of capture and polishing steps such as in HIC, SEC, mixed mode chromatography, as well as combinations of these technologies. The availability of a greater number of columns provides a particular benefit to applications with feeds that have been concentrated and those with production titers greater than 5 g/L.

Compared with competing systems, the Cadence BioSMB system is designed to offer far greater capabilities than those that can be provided by simple chromatographic media utilization optimization. As an example, the position of the buffer selection valves in the Cadence BioSMB PD system is very different from other systems and contributes directly to process optimization in multiple ways. Because each column used with the Cadence BioSMB PD system is assigned a series of valves arranged in a single-use array, the result is that every pump is delivering one buffer throughout the entire process and will never undergo composition gradients and/or wash steps. In addition, the system volume that actually is subject to composition changes in the Cadence BioSMB PD system is minimized well beyond that of other system designs. This eliminates many of the uncertainties associated with scale-up/scale-down, validation and process control.



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Description
Continuous Single-Use,
Multi-Column Chromatography

Pall’s Cadence BioSMB platform is the first disposable flow path, continuous multi-column chromatography solution that is fully scalable from the Process Development (PD) laboratory to GMP manufacturing. The BioSMB system is specifically designed to allow users to convert an existing batch process into a continuous chromatography step without changing the chromatographic sorbent, buffer system or product quality assays. BioSMB technology provides process consistency across all scales – development, clinical and full production – and is also practical to implement in flexible, multi-product facilities.

  • Inherent unit operation efficiency of the Cadence BioSMB PD system reduces the cost of chromatographic media by up to 80% without changing either the sorbent or buffer used in the chromatographic process.
  • Entire chromatographic process can be conducted in a smaller system containing a fraction of the media and buffer that would be required in a standard batch process to produce the same amount of material.
  • Ability to use up to 16 columns increases specific productivity and application flexibility. Position of the buffer selection valve eliminates composition gradients and wash steps.

Benefits

Batch chromatographic processing typically utilizes only 50% to 70% of the chromatographic column’s total binding capacity. The Cadence BioSMB PD system, on the other hand, uses a series of substantially smaller, interconnected columns. The first column in the load zone is allowed to reach breakthrough and the product breakthrough is captured on a second column. The binding capacity of the first column can thus be exploited well beyond its batch dynamic binding capacity. In many cases, such processes can be operated close to the equilibrium or static binding capacity of the chromatographic media, thus leading to a significant reduction in chromatographic media use.

The Cadence BioSMB PD system use of continuous countercurrent loading means that the load zone must accommodate only the mass transfer zone, which generally represents a small percentage of a batch column. This allows the entire process to be conducted in a much smaller system carrying only a fraction of the chromatography media used in a standard batch process. When used in larger scale applications, BioSMB technology can eliminate the need for packing skids, large stainless steel columns, and other support infrastructure. This results in a smaller overall footprint and a more scalable configuration.

While competitive systems use a complex set of valves, the Pall BioSMB technology uses an integrated valve cassette specially designed and patented as a single-use component. The new valve system eliminates the need for a difficult cleaning validation process.

The ability to use up to 16 columns with Cadence BioSMB PD system means that it supports the broader application base of capture and polishing steps such as in HIC, SEC, mixed mode chromatography, as well as combinations of these technologies. The availability of a greater number of columns provides a particular benefit to applications with feeds that have been concentrated and those with production titers greater than 5 g/L.

Compared with competing systems, the Cadence BioSMB system is designed to offer far greater capabilities than those that can be provided by simple chromatographic media utilization optimization. As an example, the position of the buffer selection valves in the Cadence BioSMB PD system is very different from other systems and contributes directly to process optimization in multiple ways. Because each column used with the Cadence BioSMB PD system is assigned a series of valves arranged in a single-use array, the result is that every pump is delivering one buffer throughout the entire process and will never undergo composition gradients and/or wash steps. In addition, the system volume that actually is subject to composition changes in the Cadence BioSMB PD system is minimized well beyond that of other system designs. This eliminates many of the uncertainties associated with scale-up/scale-down, validation and process control.

Applications
 


Applications

Cadence BioSMB PD technology is the ideal solution for biopharmaceutical production applications ranging from early stage process development through clinical manufacture and beyond. This integrated single-use device contains all the valves necessary to fully automate a wide variety of chromatographic processes including bind/elute chromatography (Protein A affinity, ion exchange, mixed mode, hydrophobic interaction) and flow through such as size exclusion or ion exchange polishing. It provides an open platform for downstream processing that enables the use of any separation technology including packed bed chromatography, membrane chromatography, monoliths, and expanded bed adsorption (EBA) chromatography.

Specifications

General Specifications

Width / Depth / Height

120 / 73 / 58 cm (47.2 / 28.7 / 22.8 in.)

Weight

170 kg (375 lbs)

Electrical Requirements

115 V or 230 V

Required Air Supply

At least 1 barg (14.5 psig) above process pressure

System and Valve Cassette Specifications

Flow Rate Range

1 mm cassette: Up to 50 mL/min
3 mm cassette: Up to 100 mL/min

Inlets

Maximum 8 (including loopback)

Outlets

Maximum 6 (including loopback)

Columns

Maximum 16

Maximum Operating Pressure

10 barg (145 psig)

Sensor Specifications

Pressure

Linear up to 13.8 barg (200 psig)

Ultraviolet-Visible (UV-VIS)

Four UV-VIS sensors each with wavelengths in 210-850 nm range

pH

Maximum 8 Range of 0-14, accuracy of 0.1 pH unit (from 2 to 12)

Conductivity

Range: 1 μS/cm – 200 mS/cm
Accuracy: 0.25 mS/cm (range 10 – 200 mS/cm) 3.0 μS/cm (range 0 – 100 μS/cm)

Pump Specifications

Maximum of 7 pumps
Stepper motor belt drive dual piston pumps, PEEK fluid path, automated piston seal wash, double capsule check valve with additional anti-siphoning valve

Accuracy

0.5 - 50 mL/min ± 5% (with 1 mm cassette)
0.5 - 100 mL/min ± 5% (with 3 mm cassette)

Additional Information

 


Continuous Biomanufacturing Implementation Now and in the Future

Ordering Information
 
Part Number Description
BIOSMB-PD-LD100 BioSMB PD 1 mm Process Development System
BIOSMB-VC-1 BioSMB PD 1 mm Process Development Valve Cassette only
BIOSMB-VC-3 BioSMB PD 3 mm Process Development Valve Cassette only
BIOSMB-PW-200 Pump wash kit 1-200 mL/min
BIOSMB-TK-1A 1 mm tubing kit - LD100 pumps ONLY with 1 mm cassette
BIOSMB-TK-3A 3 mm tubing kit - LD100 pumps ONLY with 3 mm cassette
BIOSMB-PH BioSMB pH probe
BIOSMB-PH-1 BioSMB pH housing for 1 mm setup
BIOSMB-PT-1 BioSMB pressure transducer
BIOSMB-COND BioSMB conductivity sensor
BIOSMB-UV-1S Cadence BioSMB UV flow cell, 2.5 mm optical path
BIOSMB-UV-1L Cadence BioSMB UV flow cell, 10 mm optical path
BIOSMB-PD-CH Pack of column holders
 
Application
Systems
Segment
Continuous Processing