Evaluation of the Financial Impact of Continuous Chromatography in the Production of Biologics
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, Resolute® BioSMB leverages Multi-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. Resolute® BioSC also provides a route for multi-use multi-column operations.
Choose the Right System
Find the Right Multi-Column Chromatography Solution
The Resolute® 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. Resolute® BioSMB PD is designed for process development and small-scale manufacturing, while Resolute® BioSMB Process systems are designed for clinical and commercial manufacturing. In the latter, there are two flow range variants available — Resolute® BioSMB Process 80 and Resolute® BioSMB Process 350. The two systems cover typical single-use perfusion and fed-batch bioreactor-based processes.
| Resolute® BioSMB PD | Resolute® 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 |
| Explore Resolute® BioSMB PD | Explore Resolute® BioSMB Process | Explore Resolute® BioSC |
Resolute® BioSMB PD
Resolute® 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 Resolute® 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
Explore Resolute® BioSMB PD Request a Demo
Resolute® BioSMB Process 80/350
The Resolute® 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 — Resolute® BioSMB Process 80 and Resolute® 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
Explore Resolute® BioSMB Process Request a Demo
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.
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Virtual Demo of the Resolute® BioSMB MCC Platform
To learn more about how the Resolute® BioSMB platform reduces resin utilization by 80% versus batch chromatography and enables rapid process scale-up,...
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.
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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
Featured Assets
Success Story - Resolute® BioSMB for Increased Productivity at mAB Capture Step
Our experts recommended that a CDMO upgrade from traditional batch chromatography to the Resolute® 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.
Read the Success Story
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.
Read the Case Study
Related Assets
MCC Process Modelling for Process Performance Prediction
5 Reasons to Switch to Multi-Column Chromatography
Resolute® In with the New: Embracing Multicolumn Chromatography
Consult Our Experts
Source: https://www.sartorius.com/en/products/process-chromatography/chromatography-systems/continuous-chromatography
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