BioSMB PD - Multi-Column Chromatography for Early-Stage Process Development
The BioSMB PD system is a multi-column chromatography (MCC) solution sized for lab-scale process development. Unlike batch chromatographic processing, which relies on a single large column, the BioSMB PD system can process from 1 to 16 columns.
The use of MCC leads to increased productivity and a consequent significant reduction in chromatographic resin use.
Inherent unit operation efficiency of the system reduces resin costs by up to 80% without changing either the separation media or buffer used.
Availability of 16 column positions can support a range of capture and polishing steps, such as in HIC, SEC and mixed-mode chromatography.
Valve technology, flow path configuration and recipe handling consistent between benchtop and GMP scale systems to ensure scalability.
Disposable valve cassette designed as a single-use component, eliminating the need for difficult cleaning validation processes.
Eliminate the need for packing skids, large stainless-steel columns and other support infrastructure .
Selecting The Right Technology for Your Process : Batch vs Continuous
As the industry moves toward process intensification and continuous processing, the BioSMB platform provides an ideal opportunity to start exploring possible starting points. For customers seeking lower production costs with a single-use solution for clinical and commercial processing, BioSMB can reduce resin usage by up to 80% with minimal disruption to the accepted ways of doing chromatography today. This presents a considerable saving on operational expenditure, particularly when considering affinity capture steps.
For users who are actively evaluating perfusion, BioSMB delivers a viable entry point and scale-up pathway.
The BioSMB platform provides:
- A highly flexible multicolumn chromatography system
- High throughput and very efficient resin utilization
- An open platform that enables the use of many chromatography technologies
- A fully scalable solution for applications ranging from early-stage process development through clinical manufacture and beyond
Designed for Performance and Productivity
Because the BioSMB PD system contains 16 smaller columns, it overcomes many limitations of larger, single-column batch systems. The first column in the load zone is allowed to reach breakthrough, and product breakthrough is captured on a second column. As a result, the binding capacity of the first column far exceeds its batch dynamic binding capacity. In many cases, processes can be operated close to the equilibrium or static binding capacity of the resins, leading to a significant reduction in overall resin usage.
The BioSMB PD system:
- Uses only a fraction of the chromatography resin used in a standard batch process
- Offers a smaller overall footprint and more scalable configuration
- Accommodates production titers greater than 5 g/L
- Automates a wide variety of separation modes, including bind/elute mode and flowthrough mode
System Details
General Specifications
Item | Description |
|---|---|
Width / Depth / Height | 120 / 73 / 58 cm |
Weight | 170 kg |
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
Item | Description |
|---|---|
Flow Rate Range | 1 mm cassette: Up to 50 mL/min |
Inlets | Maximum 8 (including loopback) |
Outlets | Maximum 6 (including loopback) |
Columns | Maximum 16 |
Maximum Operating Pressure | 10 barg (145 psig) |
Sensor Specifications
Item | Description |
|---|---|
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 |
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)
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 |
Simplify the Management and Analysis of BioSMB PD Data
With our BioSMB Data Analysis and Reporting software, users can speed up processing large volumes of BioSMB PD data in a user-friendly interface. This software is designed to:
- Perform a wide range of chromatography calculations on both peaks and transitions
- View and Analyze historical BioSMB PD results rapidly
- Visualize BioSMB PD data from multiple cycles or runs
Learn More About the BioSMB PD System
Meet the New Generation of Celsius® FFT and FFTp | August 31
Webinar explores expertise and experimentation behind the new generation of Celsius® FFT products
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.
