Chromatographic Clarification for Biopharmaceutical Manufacturing
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Redefine and simplify your pharmaceutical manufacturing process. 3M’s anion exchange (AEX) chromatography, single-use, hybrid purifier is designed for bringing chromatography in upstream processing for particle control and reduction of DNA and host cell proteins. Our new solutions are the next generation in harvest and clarification technology. They are designed as an efficient option to increase monoclonal antibody (mAb) yields while streamlining the upstream process.
Single-use chromatographic clarification and polishing using anion exchange chromatography (AEX)
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Next-generation harvestThe next generation in harvest and clarification technology, 3M™ Harvest RC, is designed as an efficient option to increase monoclonal antibody (mAb) yields while streamlining the upstream process by replacing the centrifuge and/or depth filtration process steps.
Features:
- Capsule format enables typical product recoveries of >95%
- Replaces primary, secondary, and guard membrane clarification stages
- Predictably scales from discovery to manufacturing in terms of clarification consistency and cell loading capacity
- Fits into discovery to manufacturing scale workflows with a range of product formats
- Lowers total cost of manufacturing compared to conventional approaches
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Polishing3M™ Polisher ST is an anion exchange (AEX) chromatographic solution designed for the downstream processing of monoclonal antibodies (mAbs) and other recombinant proteins in flow-through mode. 3M Polisher ST is designed to reduce host cell protein impurities, viruses and other negatively charged contaminants in flow-through polishing chromatography of biopharmaceutical process streams.
3M Polisher ST is a synthetic, hybrid purifier containing two complementary AEX-functional media: a quaternary ammonium (“Q”) functional nonwoven and a guanidinium-functional membrane. The upstream Q-functional nonwoven provides reduction of turbidity (when present), DNA, and endotoxin, as well as a portion of the product’s AEX capacity for HCP and virus reduction. The downstream guanidinium functional membrane layers of 3M Polisher ST are salt tolerant and provide high HCP and virus reduction performance in a wider range of conditions compared to conventional Q-functional AEX resins.
Chromatography in upstream and downstream processing
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Purification in upstream processing3M Harvest RC is a solution that utilises fibrous anion exchange (AEX) chromatography to efficiently separate the cells, cell debris and DNA from the harvest fluid containing the target product.
The anion exchange chromatography of the functional nonwoven provides substantial reduction of soluble impurities and of insoluble particles. The harvest and clarification technology is designed as an efficient option to increase monoclonal antibody (mAb) yields while streamlining the upstream process by replacing the centrifuge and/or depth filtration process steps.
Users may see substantial reductions of DNA and host cell proteins (HCP). Integrating the purifier at the clarification stage may reduce the total cost of ownership for the monoclonal antibodies (mAb) purification process.
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AEX chromatography in downstream processing3M Polisher ST is a synthetic, fully encapsulated anion exchange product containing two complementary AEX-functional medias: a quaternary ammonium (“Q”) functional nonwoven and a guanidinium-functional membrane. The Q-functional nonwoven provides reduction of turbidity (when present), DNA and endotoxin, as well as a portion of the product’s AEX capacity for HCP and virus reduction. The guanidinium functional membrane provides salt tolerant HCP and viral clearance over a wider range of pHs compared to the Q chemistry.
3M Polisher ST eliminates the need for packing and cleaning validation and has 100X higher binding capacity for proteins, viruses, virus-like particles, and other large negatively charged complexes when to compared to resins.
Featured Applications
From anion exchange chromatographic clarification of cell cultures, to bioburden reduction and flow through chromatography for polishing, 3M provides a range of technologies to deliver robust scalable solutions for applications in biotech.
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Clarification tools designed for particle size control in clarified cell culture fluid. 3M offers efficient depth filters that enable high throughput. This can eliminate the need for centrifugation and enable implementation of a fully single-use clarification process train, completely scalable from lab to pilot to manufacturing.
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Reduce insoluble impurities to help prevent plugging or fouling of capture and polishing chromatography columns.
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Reduce microorganisms and control fine particles downstream.
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Reduce DNA to target specification to help meet U.S. FDA requirements for protein therapeutic formulations.
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Polishing
3M Polisher ST is a compact, small footprint solution. It has a high capacity and can deliver greater purity and yield in the polishing step of the downstream process. 3M Polisher ST allows a facility strategy that can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for biologics. It can be deployed in a batch process or as part of a connected continuous downstream process for the flexible facility of the future. Find out more in the brochure below.
Improve efficiency in your biopharmaceutical manufacturing process
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3M™ Harvest RCThe next generation in harvest and clarification technology is designed as an efficient option to increase monoclonal antibody (mAb) yields while streamlining the upstream process by replacing the centrifuge and/or depth filtration process steps.
Precision quaternary ammonium (Q) functionalized polypropylene fibre, combined with a 0.2 µm PES membrane, provides scalable and predictable clarification from discovery to commercial manufacturing scale.
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3M™ Emphaze™ AEX Hybrid Purifier3M chromatography single use hybrid purifiers are designed for soluble and insoluble impurities reduction using anion exchange chromatography in clarification of mAbs and other recombinant proteins. Designed for DNA reduction, 3M™ Emphaze™ AEX Hybrid Purifier is a multi-mechanism single-use device containing anion exchange chromatography media integrated with a fine particle, bioburden reduction membrane.
The 3M Emphaze AEX Hybrid Purifier is a combination of two types of media (anion exchange chromatographic functional nonwoven and membrane) that work together to provide unsurpassed product purity when using a single unit operation. The integral combination of the 0.2 micron rated membrane and anion exchange nonwoven provides robust reduction of insoluble particles well below 0.1 micron.
Want to simplify your process?
Innovation in cell culture production has created additional complexities for the clarification process. 3M offers single-stage and single-use solutions to help simplify your process and increase manufacturing efficiency.
Ask an expert
Fill out this form for any technical or process-related question, and an appropriate 3M Biopharmaceutical representative will contact you to answer your question or direct your request.
Explore publications from industry experts to learn about the latest innovations and emerging trends in chromatographic clarification for pharmaceutical manufacturing.
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Research Paper: Chromatographic clarification enhances continuous Protein A performance. -
Research Paper: Impact of clarification on problematic HCP removal of Protein A chromatography. -
Technical Note: Removal of problematic host cell proteins (HCPs) in downsteam mAb purification. -
Application Note: Endotoxin removal by 3M™ Emphaze™ AEX Hybrid Purifier.
