- OVERVIEW
- PRODUCTS
- 3M™ Emphaze™ AEX Hybrid Purifier
- 3M™ Harvest RC Chromatographic Clarifier
- 3M™ Polisher ST
- 3M™ Zeta Plus Depth Filters
- 3M™ LifeASSURE™ Filters
- View All Products
- SOLUTIONS
- Harvest and Clarification Solutions
- Fiber Chromatographic Clarification Solutions
- Purification and Contaminant Removal Solutions
- View All Solutions
- APPLICATIONS
- mAb and Recombinant Protein Manufacturing
- Plasma Fractionation
- Gene Therapy
- Vaccines
- Chemical Pharmaceuticals
- EDUCATION
- SUPPORT
Harvest and Clarification Solutions
Drive efficiency in your biopharmaceutical manufacturing process.
Find solutions from core methods to next-generation technologies
Increasing cell densities and titers in pharmaceutical manufacturing, along with changing regulations and the desire for single-use technologies, are driving developments in the harvest and clarification of cell culture. 3M can help you address these trends in cell culture purification while driving efficiency in your biopharma manufacturing, whether you are using depth filtration or next-generation technologies like fiber chromatographic clarification.
Streamline your harvest and clarification process
Advancements in cell culture engineering means higher productivity and higher cell densities. This has shifted the burden to clarification and downstream processing. Learn how we can help to efficiently separate cells, cell debris and DNA from the harvest fluid with single-step chromatographic clarification.
Benefits of fiber chromatographic clarification
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Cleaner effluent: introduce chromatographic separation earlier to remove soluble impurities such as DNA -
High purity: lower HCPs and DNA post Protein-A -
Linear scalability: from lab to commercial production
Fiber chromatographic clarification FAQ
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What is fiber chromatography?
Fiber chromatography is one of the chromatography methods which utilise fibrous matrix as chromatographic media. Due to larger porous structure of fibrous media, fiber chromatography can process significantly larger biological targets, such as cells, micelles, virus and chromatic DNA, which are too large for traditional chromatographic media like chromatographic beads and chromatographic membrane. Also, binding is predominantly convection-driven, enabling a fast processing rate.
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What is the difference between depth filtration and chromatographic clarification?
Depth filtration removes contaminants primarily by size, while chromatographic clarification removes contaminants by charge. For direct clarification of harvested cell culture fluid, depth filtration typically needs two-stage (primary and secondary depth filters), while chromatographic clarification is one-stage.
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Can fiber chromatography be used in harvest and clarification?
Yes. Fiber chromatography can be used in harvest and clarification and offer many benefits including high mAb recovery (>95%), consistent high quality of clarified fluid and linear scalability from lab to pilot to manufacturing.
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Are single-use chromatography technologies cost effective?
Yes. Single-use chromatography provide overall cost reduction of biotherapeutic production.
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Can fiber chromatography replace a depth filter upstream?
Yes. Fiber chromatography can be used for harvest and clarification instead of depth filtration.
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Can fiber chromatography reduce cell shear during the clarification?
Yes. Direct clarification by fiber chromatography minimises cell shear due to low-pressure operation.
Depth filters use porous filtration media to retain particles throughout the media, rather than just on the media surface. They are commonly used when process fluid contains a high particle load because, relative to other types of filters, they can retain a large mass of particles before becoming clogged.
High-performance filter media combined with proper media selection and sizing can provide excellent throughput performance and filtration efficiency for legacy processes. 3M™ Zeta Plus™ EXT Series Depth Filters’ dual-layer construction can enhance the filter’s contaminant holding capacity, reducing premature plugging and helping extend the service life of the media.
Depth filtration FAQ
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How does depth filtration work?
Depth filtration utilizes the thickness, or depth, of the filter media to trap insoluble suspended particles, separating them from the process fluid that passes through the media. Particles are captured by various mechanisms through the tortuous or complex path of the media, including direct interception, inertia impaction and electrostatic adsorption.
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Is a depth filter a membrane filter?
Depth filters differ from membrane filters in that they do not have a defined, or absolute, pore size. Membrane filters have holes or pores in the surface of the filter that will trap larger objects while those smaller than the pore will flow through. Therefore, membrane filters’ only mechanism of action is mechanical sieving. Depth filters, on the other hand, must rely on a combination of materials and thickness to create a maze or tortuous pathway to trap the suspended particles.
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What are the primary materials used to make a depth filter?
Depth filters are comprised typically of three components: cellulose, a filter aid, and a polymer binder resin. The material can also be functionalised to contain additional functional chemistry for enhanced performance.
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What are the optimal number of depth filters necessary for monoclonal antibodies (mAb) manufacturing?
Depending on the process, a mAb purification train will traditionally utilise a two-stage depth filter operation. The filter(s) used in the first stage have a wider nominal pore size to remove larger cells and insoluble fragments. The fluid is then fed into a filter with a narrower nominal pore size to remove finer debris. Depth filters with a certain level of positive charge may also remove some negatively charged DNA and host cell proteins.
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What is the difference between single-layer and dual-layer depth filters?
Single-layer depth filters contain only a single layer of filtration media. 3M™ Zeta Plus™ EXT Series Filter Capsules and Cartridges have dual-layer configuration with two distinct layers or zones of filter media. This construction increases the holding capacity of the filter, extending its service life and providing enhanced clarification of biological fluids. In some processes, using two or more single-layer depth filters in a chain may be advantageous, as each filter could serve a specific purpose that might not be possible with a dual-layer filter.
Biopharmaceutical industry trends
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Industry leaders discuss next-generation bioprocess and future approaches that deliver high productivity, increased manufacturing flexibility and increased speed with reduced risk.
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Cell harvesting and clarifications are both crucial steps that can have a significant impact on the design of downstream processes. By mapping the different process inter-dependencies, harvest and clarification operation can be optimised.
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From Frost & Sullivan, "A Virtual Think Tank Executive Summary - A Frost & Sullivan Perspective on Next Generation Harvest Techniques" summarizes discussions from academic and industry leaders.
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Find 3M biopharmaceutical solutions
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Find solutions for process-related impurities leveraging membrane and chromatography technology.
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Find solutions for more efficient bioprocessing across our portfolio.
Explore applications
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One step can transform your mAb and recombinant protein manufacturing process. At 3M, we’re helping build better, more efficient and simpler manufacturing processes by developing solutions to enhance biologic drug recovery that leads to improved process economics.
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Gene therapy is a fast-changing, promising field with new challenges for manufacturing and separation. Learn how we can help with our technologies and expertise.
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Plasma fractionation has existed for decades, but additional separation methods are becoming increasingly common. We offer a range of products to help you with your process.
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Getting the most out of your manufacturing process with speed and on budget is an increasing challenge. Our solutions may help you develop manufacturing processes for vaccines to help maximise purity, leading to overall process economics.
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If you need solutions for catalyst removal and recovery, colour removal, particulate filtration and fill-finish, 3M offers a wide range of adsorptive depth filters and membrane products for application in the chemical pharmaceutical manufacturing.
