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.
Multi-column chromatography system improves resin utilization and reduces buffer quantities decreasing overall manufacturing costs
Multi-column chromatography can lead to a 3- to 5-fold increase in productivity
The BioSMB Process systems enable single-use scale-up and use the same valve technology, recipes and flowpath configuration as the BioSMB PD system
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
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.
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
System Details
BioSMB Process 80 Complete Hardware Systems
Each BioSMB Process 80 system has the following architecture
Item | Description |
|---|---|
Dimensions | 2.7/1.3/2.1 m (106/51/83 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 | 8 |
Number of pumps | 7 |
Maximum operating | 4 bar (58 psi) |
Air supply | 6 bar (87 psi) with integrated pressure regulator |
Electricity supply | 3 phase 400 V – 32 A – 50 Hz |
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. |
Pressure | 7 pressure transmitters (1 after each pump with integrated pressure switch) |
Flow | 7 ultrasonic non-invasive flowmeters (1 after each pump) |
Air | 7 integrated with flowmeters |
Conductivity | 4 sensors (on outlets 1-4) |
pH | 4 sensors (on outlets 1-4) Range of 2-10, |
UV | 4 UV-VIS sensors each with wavelengths in |
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 | 2.7/1.3/2.1 m (106/51/83 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 | 8 |
Number of pumps | 7 |
Maximum operating | 4 bar (58 psi) |
Air supply | 6 bar (87 psi) with integrated pressure regulator |
Electricity supply | 3 phase 400 V – 32 A – 50 Hz |
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 |
Pressure | 7 pressure transmitters (1 after each pump with integrated pressure switch) |
Flow | 7 ultrasonic non-invasive flowmeters (1 after each pump) |
Air | 7 integrated with flowmeters |
Conductivity | 4 sensors (on outlets 1-4) |
pH | 4 sensors (on outlets 1-4) Range of 2-10, |
UV | 4 UV-VIS sensors each with wavelengths in |
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. | |
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 |
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.