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Anion exchange chromatography

Overview Efficiencies gained  Video: 3M™ Polisher ST AEX technology School of Purification  FAQ Next steps Ask an expert
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Overview
Efficiencies gained 
Video: 3M™ Polisher ST
AEX technology
School of Purification 
FAQ
Next steps
Ask an expert

We solve the challenges of process intensification and loading capacity 

Protein purification has significant downstream effects, particularly when moving from lab to production, and can be challenging to scale while intensifying the process and achieving high loading capacity. Solventum brings innovative solutions to AEX polishing unit operations that incorporate both a Q-functionalized fibrous non-woven and an innovative guanidinium-functionalized membrane, which combined provide robust viral clearance and host cell protein reduction. Operating across a wide range of conditions, 3M™ Polisher ST allows you to do more with less. It’s also available for easy trialing, so our experts can show you how to optimize your process to address your manufacturing challenges.  

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Simplified, intensified, time and cost-efficient purification 

3M™ Polisher ST can replace multiple steps downstream 

With its proprietary technology that enhances mAb recovery and viral clearance with marked reductions in HCPs, the 3M™ Polisher ST can help you simplify your process and replace multiple steps. Our global experts can help you determine the right product for your process, helping you save time and money as you compress purification and contaminant removal into a single step. 

Explore 3M™ Polisher ST 
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Reach full-scale production, faster

Elevating the efficiency of your downstream process (DSP), the 3M™ Polisher ST will help your innovations go from idea to full-scale production — fast. It is a synthetic, fully encapsulated single-use AEX device that contains two complementary AEX-functionalized media including one with a novel guanidinium ligand. These innovative materials enhance your high productivity chromatographic purification processes which can lead to increased yields, higher purity and process intensification all in a cost-effective and compact solution that is available in lab scale for easy trialing. 

Read about new frontiers in DSP
One scientist’s hand holding two vials while another points at the contents.

Increase the yield and purity of your process 

By intensifying the polishing step, 3M™ Polisher ST eliminates the need for depth and membrane filters downstream. Enhanced viral clearance, increased mAb recovery and marked reductions in host cell protein have been independently verified in a range of operating conditions — by professionals like you. 3M™ Polisher ST is the result of our dedication to and proven expertise in membrane science for chromatography in manufacturing. 

Read peer reviewed paper
Graphic showing HCP reduction and mAb recovery contour plots

A solution for your efficiency and sustainability goals 

Greater yield per batch means you can achieve your target production with fewer batches—or higher output with the same number of batches. All while reducing costs. In a case study, 3M™ Polisher ST on its own was estimated to increase annual production capacity by 12%, while reducing the cost of goods sold by 13%. It was also estimated to reduce facility energy use by 3% and facility energy intensity by 13%.
 
Process intensification requires less floor space and less energy consumption, with corresponding decreases in greenhouse gas emissions. 3M™ Polisher ST alone can provide a reduction in energy use.
 
Even greater efficiencies are possible with other Solventum solutions in your process. 

Read the case study
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3M™ Polisher ST video

Discover the technology, performance and efficiencies that 3M™ Polisher ST can offer your bioprocessing operation.

AEX technology

Think beyond quaternary ammonium (“Q”) functional media in your downstream polishing operation. 3M™ Polisher ST has that — and more. With two complementary AEX-functional media in a single device, it has greater capacity and delivers higher purity and yield to your downstream polishing operation.  

AEX-functionalized membrane

Superior performance is obtained with the addition of three layers of a polyamide microporous membrane that have been AEX functionalized with a covalently attached guanidinium-functional polymer. Downstream of Q-functional media and with a nominal 0.8 µm pore size, the result is robust HCP and viral reduction. 

Learn more about our media
Microscopic image of membrane

Novel guanidinium ligand 

The novel guanidinium ligand mimics the positively charged amino acid, arginine. It interacts with negatively charged impurities in a salt-tolerant manner, both electrostatically and with two hydrogen bonds. The high ligand density enables 50-100x higher mAb loading capacity than traditional chromatography resin beads. 

Discover the guanidinium ligand
Line art illustration of buanidinium ligand

mAb recovery 

3M™ Polisher ST has robust mAb recovery. It can achieve >95% recovery in monovalent or polyvalent buffers, irrespective of pH (from 5.0 to 7.5) and conducivity (from <5.0 mS/cm to 20 mS/cm). 

See mAb recovery data
Bar graph depicting % mAb recovery in monovalent and polyvalent buffers

HCP reduction

With high dynamic antibody-loading capacities (10 kg/m2) and one-fifth the residence time of Q-resin, 3M™ Polisher ST achieves >60% HCP removal in a phosphate buffer and >22% removal in a citrate buffer in a VIN mAb pool with ~500 ppm HCP.

Learn more about HCP reduction
Bar graph depicting HCP reduction in monovalent and polyvalent buffers

Viral clearance

Under process conditions of 5 to 20 mS/cm and a pH 5.5 to 7.5, 4 to 7 LRV can be achieved using 3M™ Polisher ST. For XMuLV, Reo-3 and PrV, >6 LRV was seen, and >4 LRV for MVM.

View viral reduction results
Bar graph depicting BSA DBC at 10% Breakthrough

Scalability 

3M™ Polisher ST can help get your innovations from bench to market. 3M™ Polisher ST lab and scale-up capsules have target mAb loading capacities from 1 g to 1 kg. The bovine serum albumin (BSA) protein dynamic binding capacity (DBC) per unit area was consistent across all capsule sizes.

See scalability information
Bar graph depicting BSA DBC at 10% Breakthrough

School of Purification: Start learning today

Developed by our global experts, passionate about innovative approaches to biopharmaceutical separation and purification, School of Purification provides resources to help you and your team ramp up quickly. These free webinars and on-demand learning resources cover overcoming bottlenecks, optimizing efficiency, current trends, and future possibilities.

Explore School of Purification
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Explore 3M™ Polisher ST frequently asked questions 

Yes. Modern chromatographic membranes such as 3M™ Polisher ST have been shown to be robust and scalable from the bench up to production scale. This allows for a single-use chromatographic device to replace a large, multi-use column, saving space and buffers. 

Yes. Newer anion exchange functionalities, such as guanidinium and, to a lesser extent, primary amines, have been shown to be able to remove problematic HCPs under a wider range of conditions, compared to traditional Q chemistries. 

The benefits of 3M™ Polisher ST include a smaller footprint, higher loading capacities, less buffer usage and no need to pack/repack/validate. 

Yes, 3M™ Polisher ST is also an effective virus removal step as part of an orthogonal viral clearance technology platform. Under process conditions of pH 5.5 to 7.5 and 5 to 20 mS/cm, 4 to 7 LRV can be achieved. Viral clearance performance is independent of the format, for example, the traditional AEX column vs. 3M™ Polisher ST. Performance is directly related to the functional ligand, feed and process conditions used. 

Next steps

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