BioSMB Process 80/350

Single-Use Multi-Column Chromatography for Clinical and Commercial Manufacturing

The BioSMB Process system uses the principle of multi-column chromatography to enable manufacturers to fully utilize resins at clinical and commercial scale, significantly reducing resin costs. In fact, the BioSMB platform is the first single-use solution on the market that can be scaled up from process development to commercial manufacturing. These systems are viable as a direct replacement for a single chromatography unit operation within a batch process, providing an entry point to process intensification in downstream unit operations.

Up to 80% reduction in resin costs

Multi-column chromatography system improves resin utilization and reduces buffer quantities decreasing overall manufacturing costs

3-5x increase in productivity

Multi-column chromatography can lead to a 3- to 5-fold increase in productivity

Scale up to single-use processes

The BioSMB Process systems enable single-use scale-up and use the same valve technology, recipes and flowpath configuration as the BioSMB PD system

Modular and flexible design

The system comes with multiple flow paths & column arrangements that can accommodate batch or continuous processes and eliminates the need for packing skids and large stainless-steel columns

Quick and easy changeovers

Easy-to-install manifolds, which can be placed onto the system in less than 30 minutes

Versatile Platform for Continuous or Batch Chromatography

The BioSMB platform is a multi-column chromatography system that delivers high throughput and efficient resin utilization when used in batch configuration or for continuous chromatography. This is achieved through a unique single-use, eight-column system architecture, which enables a highly flexible flow configuration through the single-use valve cassette.  

There are two flow range variants available  

  • BioSMB Process 80 system for perfusion based or continuous chromatography. 
  • BioSMB Process 350 system for batch processes. Chromatographic processes developed using batch chromatography can be readily scaled without changing the sorbent, buffer system or product quality assays. 

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Seamless Scale-up from Process Development to GMP Manufacturing

The BioSMB Process has a single-use flow path, a feature that no other system has. The single-use flow path helps increase turn-around efficiency, reduce cleaning validation, minimize bioburden risk and product carry over in a multi-product facility. Single-use and Multi-use manufacturing strategies are generally fixed at the time of plant design. Multi-column chromatography and single-use are closely aligned and make most sense when coupled as a manufacturing strategy.  

In addition, the BioSMB Process systems provide: 

  • Consistent product quality comparable to batch processing  
  • Significant productivity increases  
  • Longer run times, with control and monitoring provided by integrated software 

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System Details

BioSMB Process 80 Complete Hardware Systems

Each BioSMB Process 80 system has the following architecture

Item

Description

Dimensions
w/d/h

2.7/1.3/2.1 m (106/51/83 in.)
Height without alarm tower: 1.9 m (75 in.)

Flow Rate Range

5 - 80 L/h

Weight

1500 kg

Inlets

8 (7 usable + 1 for system use as second pass)

Outlets

6 (5 usable + 1 for system use as second pass)

Number of column
positions

8

Number of pumps

7

Maximum operating
pressure

4 bar (58 psi)

Air supply

6 bar (87 psi) with integrated pressure regulator

Electricity supply

3 phase 400 V – 32 A – 50 Hz
(other voltages available)


BioSMB Pump Modules

If a complete BioSMB Process 80 system is purchased, then it is possible to buy a BioSMB Process 80 pump module to increase the flexibility of the main system.

The pump module can be exchanged easily, requiring a mechanical changeout of the module and a switch in the software. The mechanical swap of the two pump modules typically takes less than an hour. This modularity allows the system to run from 5 L/h - 80 L/h.

If a BioSMB Process 80 pump module is used then the BioSMB Process 80 manifold set must be used.


BioSMB Process 80 - Manifold Specifications

Item

Description

Hose and connectors 

Silicone braided tubing ID: 1/4 in. Kleenpak® Presto sterile connector for external connections.
HFC39 connectors for internal connections
(NOTE: The process 80 manifold is available with sanitary connection connections in place of the Kleenpak connectors.)

Pressure

7 pressure transmitters (1 after each pump with integrated pressure switch)
0 to 5 barg/72 psig
(NOTE: Maximum operating pressure for system is 4 barg/58 psig)

Flow

7 ultrasonic non-invasive flowmeters (1 after each pump)

Air

7 integrated with flowmeters

Conductivity

4 sensors (on outlets 1-4)
Range: 0 μS/cm – 150 mS/cm, accuracy of 2% measuring range
Built-in temperature compensation and monitoring.

pH

4 sensors (on outlets 1-4) Range of 2-10,
accuracy of 0.15 pH unit

UV

4 UV-VIS sensors each with wavelengths in
280 nm as standard
0-2 AU

Process pump

4 piston diaphragm single-use The single-use pump heads are Quattroflow™ sanitary diaphragm pumps, 4 pistons with polypropylene (PP), ethylene propylene diene monomer (EPDM)/PP compound diaphragm and EPDM valves

Gamma irradiation dose

25 kGy


Process Wetted Components Materials of Construction

Description

Materials

Tube

Platinum cured silicone

Fittings

Polycarbonate, polypropylene, polyphenylsulfone

Valve diaphragm

Fluoroelastomer (FKM)

pH sensor

Glass

Pump head

Polypropylene, EPDM/PP compound

Pressure sensor

Polysulfone

UV-VIS sensor windows

Quartz

Conductivity sensor

Polysulfone

BioSMB Process 350 Complete Hardware Systems

Each BioSMB Process 350 system has the following architecture

Item

Description

Dimensions
w/d/h

2.7/1.3/2.1 m (106/51/83 in.)
Height without alarm tower: 1.9 m (75 in.)

Flow Rate Range

30-350 L/h

Weight

1500 kg

Inlets

8 (7 usable + 1 for system use as second pass)

Outlets

6 (5 usable + 1 for system use as second pass)

Number of column
positions

8

Number of pumps

7

Maximum operating
pressure

4 bar (58 psi)

Air supply

6 bar (87 psi) with integrated pressure regulator

Electricity supply

3 phase 400 V – 32 A – 50 Hz
(other voltages available)


BioSMB Pump Modules

If a complete Process 350 system is purchased, then it is possible to buy a BioSMB Process 350 pump module to increase the flexibility of the main system.

The pump module can be exchanged easily, requiring a mechanical change out of the module and a switch in the software. The mechanical swap of the two pump modules typically takes less than an hour. This modularity allows the system to run from 30 - 350 L/h.

If a BioSMB Process 350 module is used then a BioSMB Process 350 manifold set must be used.


BioSMB Process 350 Platform - Manifold Specifications   

Item

Description

Hose and connectors 

Silicone braided tubing ID: ⅜ in. with HFC39 connectors for internal connections and sanitary connection clamp 3/4 in. for upstream and
downstream connections

Pressure

7 pressure transmitters (1 after each pump with integrated pressure switch)
0 to 5 barg/72 psig
(NOTE: Maximum operating pressure for system is 4 barg/58 psig)

Flow

7 ultrasonic non-invasive flowmeters (1 after each pump)

Air

7 integrated with flowmeters

Conductivity

4 sensors (on outlets 1-4)
Range: 0 μS/cm – 150 mS/cm, accuracy of 2% measuring range
Built-in temperature compensation and monitoring.

pH

4 sensors (on outlets 1-4) Range of 2-10,
accuracy of 0.15 pH unit

UV

4 UV-VIS sensors each with wavelengths in
280 nm as standard
0-2 AU

Process pump

4 piston diaphragm single-use The single-use pump heads are Quattroflow™ sanitary diaphragm pumps, 4 pistons with polypropylene (PP), ethylene propylene diene monomer (EPDM)/PP compound diaphragm and EPDM valves

Gamma irradiation dose

25 kGy


Process Wetted Components Materials of Construction

Description

Materials

Tube

Platinum cured silicone

Fittings

Polycarbonate, polypropylene, polyphenylsulfone

Valve diaphragm

Fluoroelastomer (FKM)

pH sensor

Glass

Pump head

Polypropylene, EPDM/PP compound

Pressure sensor

Polysulfone

UV-VIS sensor windows

Quartz

Conductivity sensor

Polysulfone


BioSMB Process 80 SU Systems

The BioSMB Process 80 SU system is comprised of one single manifold. The system is supplied double bagged and gamma irradiated.

Part Number

Description

BIOSMB-PF-5

BioSMB Process 80 SU system comprising inlets, valve cassette, outlets and column connectors only.
Other connectors are available on request.

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BioSMB Process 350 SU Systems

The BioSMB Process 350 SU system is comprised of four separate manifolds; inlet manifold, valve cassette manifold, column manifold and outlet manifold. These can be purchased individually, the manifolds are supplied individually double bagged and gamma irradiated.
 

Part Number

Description

BIOSMB-IT-8

BioSMB Process 350 inlet tubing set

BIOSMB-OT-8

BioSMB Process 350 outlet tubing set

BIOSMB-CT-8

BioSMB Process 350 column tubing set

BIOSMB-VB-8

BioSMB 8 mm Process 350 valve cassette

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Learn More About the BioSMB Process Systems

Virtual Demo of the BioSMB Platform

To learn how the BioSMB platform can easily scaled up from early-stage process development through clinical manufacture and beyond, watch the...

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Featured Case Study

Protein A Resin Reduction Achieved With Process Transfer From Batch to BioSMB

Sanofi wanted to upgrade from an existing batch chromatography process to the BioSMB multi-column format, then scale up that process to a continuous perfusion run. This case study details the real-world results.

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Related Assets

Application Note: BioSMB Process System - Scale-up of...

PDF 421.1 KB

Success Story: BioSMB Increased Productivity at mAB Capture Step

PDF 230.4 KB

Datasheet: BioSMB Process 80 & 350 System

PDF 1.6 MB

In with the New: Embracing Multicolumn Chromatography

PDF 595.7 KB

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