Resolute® BioSMB Platform
Single-Use Multi-Column Chromatography From Process Development to Manufacturing
Downstream process intensification starts with capture chromatography. Achieving up to 80% reduction in affinity resin use, the Resolute® BioSMB Platform is designed to eliminate throughput bottlenecks and deliver substantial cost savings.
Transitioning a chromatography method to Resolute® BioSMB multi-column chromatography offers:
- A simple, proven process backed by experience across hundreds of chromatography applications
- A validated solution suitable for both clinical and commercial GMP production
- Greater plant flexibility, enabling increased throughput and cost optimization to meet production targets
Improved resin utilization and reduced resin volumes decreases overall manufacturing costs.
Up to 2x reduction in buffer volumes, improving sustainability.
The system uses the same valve technology, recipes, and flowpath configuration for process development and manufacturing systems, streamlining scale-up.
Multi-Column Chromatography Portfolio
Multi-Column Chromatography Solutions for All Bioprocessing Challenges
Our multi-column chromatography (MCC) portfolio has been designed to support all bioprocessing challenges, including bioburden control, high-titer bottlenecks, and long-duration perfusion harvests.
| Resolute® BioSMB PD | Resolute® BioSMB 80 | Resolute® BioSMB 350 | |
|---|---|---|---|
| Flow Rate | 1-100 mL/min | 5-80 L/hr | 18-350 L/hr |
| Applications | MCC for process development | MCC single-use capture for pilot and clinical perfusion processes | MCC single-use capture for clinical and commercial perfusion and fed-batch processes |
| Scale | Process development | Manufacturing | Manufacturing |
| Column Flexibility | 1-16 columns | 1-8 columns | 1-8 columns |
| Fluid Path | Re-usable, replaceable process development flowkit | Single-use, gamma-irradiated flowkit validated for biologics manufacturing | Single-use, gamma-irradiated flowkit validated for biologics manufacturing |
|
Learn More About Multi-Column Chromatography
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Continuous Processing Can Reduce Quality Risks
MCC is a well-understood process that has been accepted in bioprocessing and does not pose substantial regulatory hurdles compared to single-column operation. In fact, many aspects of MCC contribute to a stronger, safety-focused manufacturing strategy. These include:
- Single-use closed processing for better bioburden management
- Higher resin cycling for increased data collection and easier deviation detection
- Sub-lots | batches to quarantine and avoid full batch loss
- Manageable tech transfer and scale-up thanks to the easier qualification of columns (usually less than 10 L)
Sartorius specialists are ready to support your transition to MCC and assist with any risk assessments.
- A risk-based approach to process development and qualification should be taken, just like with single-column development
- If core parameters are investigated and verified, then quality is expected to remain the same when transitioning from batch to MCC
Frequently Asked Questions
Multi-column chromatography (MCC) is a description of chromatography processes that utilize more than one column to increase the efficiency of a chromatography operation. Typically, MCC is executed by cycling more than one column with a continuous non-interrupted feed flow rate so that a batch can be processed faster and with less chromatography media.
No, columns do not need to be connected together in the loading zone of a chromatography operation. There are still benefits to operating with more than one column without sequential loading. The main benefits of this are continuous loading and column cycling. These allow the chromatographer to process material faster, with less resin, while also achieving higher resin utilization by increasing the number of cycles on the resin. Sequential loading further expands on these benefits by offering the capability to increase the operating binding capacity.
Sartorius refers to operations with sequential loading as "sequential multi-column chromatography“ (SMCC). When columns are not loaded sequentially, Sartorius uses the term "batch multi-column chromatography“ (BMCC).
There is no industry standard for the number of columns used for MCC. Optimal process design for MCC results in the "number of columns" parameter as an output, with multiple factors as inputs. These inputs could be, but are not limited to, product concentration, operating capacity, duration of process, and intended number of cycles on the columns.
Our chromatography software allows chromatographers to easily design and visualize a chromatography method as one would in standard single-column operation. The software can "balance" the number of columns to achieve the optimum performance or outputs expected by the user.
MCC is not a new concept. It does not change the chromatography process nor the separation mechanisms that are utilized in a single-column chromatography method.
At Sartorius, we don’t believe that continuous processing expertise should be required to design and understand an MCC process. Our MCC systems are designed to simplify chromatography for the user so that programming, troubleshooting, and method revision can be executed swiftly, accurately, and thoroughly. Our applications teams have experience training hundreds of customers and are confident that one day of knowledge transfer is sufficient for a new user to be capable of MCC design.
Yes. We have multiple customers, manufacturing on multiple continents, who have implemented MCC for capture chromatography in commercial processes. It has been proven that there are no insurmountable risks that could prevent MCC from being validated for commercial production.
