Continuous Chromatography
Multi-Column Chromatography Solutions for Minimizing Costs
The Sartorius chromatography systems portfolio gives the ability to intensify a process through two pathways. At the unit operation level, the BioSMB leverages Mult-Column Chromatography (MCC) to intensify any chromatography unit operation through a decrease in media usage or processing time and the ability to expand the performance envelope chromo step outside of that delivered by the batch equivalent. This could be as part of a batch or continuous process.
The other path through the Resolute® BioSC technology (Multi-Step Chromatography) allows the intensification at process level, where multiple unit operations are joined together – saving time and footprint through the consolidation of unit operations within one integrated system and the ability to conduct parallel unit operations. The Resolute® BioSC also provides a route for multi-use multi-column operations.
Choose the Right System
Find the Right Multi-Column Chromatography Solution
The BioSMB platform is a fully scalable solution for your manufacturing environment and is supported by a global Field Application Services team with MCC experts who can provide installation support. BioSMB PD is designed for process development and small-scale manufacturing, while BioSMB Process systems are designed for clinical and commercial manufacturing. In the latter, there are two flow range variants available — BioSMB Process 80 and BioSMB Process 350. The two systems cover typical single-use perfusion and fed-batch bioreactor-based processes.
BioSMB PD | BioSMB Process 80 | 350 | Resolute® BioSC | |
---|---|---|---|
Scale | PD / Clinical | Clinical | Commercial Manufacturing | Clinical | Commercial Manufacturing |
Intensification Level | Unit operation | Unit operation | Unit operation | Integrated process |
Core Capability | Multi-column chromatography | Multi-column chromatography | Multi-step chromatography |
Mode | Single-use | Single-use | Multi-use |
BioSMB PD
BioSMB PD is an integrated single-use device for process development to fully automate a wide variety of chromatographic processes, including bind/elute chromatography and flow-through polishing.
The BioSMB PD system is designed specifically for lab-scale process development and features:
- Up to 16 column positions
- Flow rate range of .06–6 L/hr
- 2 sizes of disposable flow kit, changed as part of preventive maintenance
BioSMB Process 80/350
The BioSMB Process 80 and 350 systems are sized and specified for clinical and commercial manufacturing under GMP. They feature a unique single-use, eight-column architecture for a highly flexible chromatography system that delivers high throughput and very efficient resin utilization.
There are two flow range variants available — BioSMB Process 80 and BioSMB Process 350. The two systems cover typical single-use perfusion and fed-batch bioreactor-based processes:
- Up to 8 column positions
- Flexible flow configuration through single-use valve cassette
- Flow rates ranging from 5-350 L/hr
- Interchangeable pump modules that can be swapped between systems
Resolute® BioSC
Resolute® BioSC low pressure liquid chromatography (LPLC) platform enabling batch, multiple multi-column processes (parallel batch, continuous chromatography) or multi-step integration resulting in Process Intensification.
Traditional Batch vs. Multi-Column Chromatography
Continuous Multi-Column Chromatography: Better Than Batch Chromatography
In traditional single-column batch chromatography, there are inherent limitations because the system rarely uses the full capacity of the stationary phase during loading. In multi-column chromatography, the large column is split into a number of smaller columns that can be processed individually, eliminating idle zones. In addition, the flexible valve configuration allows breakthrough of the product stream to a secondary column, which allows the full capacity of the column to be used through overloading, leading to improved process efficiency with increased resin capacity utilization.
Batch Chromatography
- Single large column
- Column capacity limited to prevent product loss
- Cycle times influenced by high operational residence times and low linear flow rates
- Resin requirements heavily influenced by batch sizes and processing time (desired throughput)
- Large columns require significant clean room space and support infastructure
Multi-Column Chromatography
- Number of smaller columns
- Efficiency Gain 1: Column overloading reduces risk of product loss and increases ability to operate at higher binding capacities
- Efficiency Gain 2: Continuous cycling operation eliminates non-loading idle time
- Resin volume requirements reduced by up to 80% without impacting process throughput
- Small footprint, eliminating the need for packing skids and other support infrastructure
How to Select Your DSP Chromatography Technology
Making the switch from single batch to multi-column chromatography can dramatically reduce resin utilization, reducing costs and eliminating bottlenecks without sacrificing quality. This animated feature compares the traditional, single column batch approach to a multi-column alternative for mAb capture.
Learn More About Continuous Chromatography
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Webinar explores expertise and experimentation behind the new generation of Celsius® FFT products
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Featured Assets
Success Story - BioSMB for Increased Productivity at mAB Capture Step
Our experts recommended that a CDMO upgrade from traditional batch chromatography to the BioSMB multi-column chromatography platform to achieve higher productivity at the mAb capture step. Read how the CDMO saw dramatic improvements in both resin utilization and measured productivity.
Case Study - Merck Process Transfer and Scale-Up of Batch Chromatography to Multi-Column Platform
The driver for the study was an exploratory evaluation of the impact and benefits of multi-column chromatography. Product quality consistency was considered, as well as the possible cost and resin savings associated with transitioning from batch to continuous.