Recombinant Protein Manufacturing

Separation and Purification Sciences - Lab Capsules
Separation and Purification Sciences
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Biopharmaceutical Manufacturing

  • When you work in the biopharmaceutical industry, you want to reduce time and bring efficiencies in the manufacturing of biologics drugs from the clinic to market. 3M products combine our expertise in material science, filtration and polishing of proteins that provide solutions in upstream and downstream processing of biologics.

    3M wants to help you do that. 3M™ Zeta Plus™ Depth Filter, 3M™ Emphaze™ AEX Hybrid Purifier, 3M™ LifeASSURE™ Filters and 3M™ Polisher ST are single-use products that enable robust purification platformability across diverse biopharmaceutical modalities, designed for all process stages from lab scale-up to manufacturing.

Monoclonal Antibodies Manufacturing

  • Monoclonal antibody (mAb) therapeutics manufacturing requires robust, scalable solutions throughout the process train from clarification to purification. 3M Zeta Plus Depth Filter and 3M Emphaze AEX Hybrid Purifier are uniquely engineered and designed specifically for the biopharmaceutical industry to optimise cell harvest and clarification needs. 3M Polisher ST is a new product uniquely engineered and designed to be a single-use cost-efficient option to increase biomass production in therapeutic recombinant protein processes across most operating conditions.

    3M Emphaze AEX Hybrid Purifier’s is a single-use technology for polishing stage clarification of mammalian cell culture fluid and is designed to reduce both soluble and insoluble impurities. 3M Emphaze AEX Hybrid Purifier combines two types of media: Q-functional nonwoven and a membrane that work together to provide high clarification efficiency in a single clarification stage. The 3M Zeta Plus Depth Filter and 3M Emphaze AEX Hybrid Purifier enable centrifuge replacement with a scalable single-use system.

    3M Polisher ST is the newest solution: a cost-efficient single-use option to allow for an increase in biomass production in therapeutic recombinant protein processes across a wide range of operating conditions. 3M Polisher ST can be used to replace downstream AEX polishing columns in both fed batch and or continuous manufacturing. It is a compact, small footprint solution with higher capacity for delivering higher purity and yield in the downstream polishing unit operation as part of a connected continuous downstream operation for the flexible facility of the future. 3M Polisher ST allows for a facility strategy that can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for biologics.


Bioprocessing reimagined

You can achieve higher yield through chromatographic clarification of cell culture fluid, including the reduction of HCP, DNA and endotoxins. The newest solution, 3M Polisher ST, is a single-use membrane adsorber purification solution designed for the downstream processing of monoclonal antibodies (mAbs) and other recombinant proteins in flow-through mode. 3M Polisher ST is designed to improve monoclonal antibody (mAb) development and manufacturing processes in a wide range of polishing process conditions. These solutions enable elimination and/or reduction in the size of unit operations, leading to better overall process economics.

These process trains illustrate how 3M products work together to create solutions that simplify the purification process and eliminate process steps.

3M Solutions

Eliminate the centrifuge

The combination of 3M™ Zeta Plus™ Series Depth Filter, 3M™ Emphaze™ AEX Hybrid Purifier and 3M™ LifeASSURE™ Membrane Filters may be a compelling alternative to a centrifuge-based Harvest-Clarification process.

Want to learn more? Check out this article.
Comprehensive options

Single-use, encapsulated devices for the removal of cell mass with low cell shear. A wide selection of grades and two charge levels for small particle removal and membrane filter protection.

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Simplify the process

Synthetic, single-use chromatographic clarification device. Delivers consistent, high-purity clarified process fluid by providing flow-through chromatographic separation of negatively charged HCP, DNA and endotoxins.

Download data sheet (PDF, 827.54 KB)

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Quality and Reliable

3M™ Emphaze™ AEX Hybrid Purifier enables use of a smaller 3M™ LifeASSURE™ PDA filter capsule and/or tighter grade membrane for more consistent bioburden control and higher product recovery.

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Cost-efficient and compact

3M™ Polisher ST is a fully encapsulated single-use anion exchange (AEX) product intended to reduce host cell protein impurities, viruses, and other negatively charged contaminants in flow-through polishing chromatography.

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Product Categories | Biomanufacturing Purification Platform

To help boost your biopharmaceutical manufacturing efficiency, 3M offers a robust portfolio of biopharmaceutical manufacturing products – from membranes and hybrid chromatographic purifiers to depth filtration systems and process hardware. Our filtration and purification products are designed for robust performance, efficiency and easy scale-up from lab scale to production scale.

  • The goal of harvest and clarification is to prepare your cell culture process fluid for downstream purification by different chromatography unit operations or steps. 3M Zeta Plus Depth Filter and 3M Emphaze AEX Hybrid Purifier help biopharmaceutical drug manufacturers design and deploy robust clarification processes. 3M solutions are designed for recombinant mAbs expressed in mammalian cell cultures and for plasma-derived proteins.

  • Our membrane filters are engineered for high-capacity and fast-flow rates. Our portfolio includes solutions for sterile filtration, bioburden control, and endotoxin reduction. Validated membranes make these filters a reliable choice for process and contaminant control strategy.

  • We combine advanced anion exchanges (AEX) chromatography media, fine fibre nonwovens and fine particle reduction membranes to create a novel purification solution. The result is a synthetic, single-use clarifying product that provides high purity.

  • 3M Polisher ST is compact, small footprint solution.

    Polishing

    The goal of the polishing step is the fast and efficient removal of residual contaminants in your process to achieve injectable product purity in the least number of polishing steps. 3M Polisher ST is a fully encapsulated single-use anion exchange (AEX) product intended to reduce host cell protein impurities, viruses and other negatively charged contaminants in flow-through polishing chromatography of biopharmaceutical process streams.

    3M Polisher ST combines two complementary synthetic AEX functional media: 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 is salt tolerant and provides high HCP and virus reduction performance in a wider range of conditions compared to conventional Q-functional AEX resins.

    3M Polisher ST eliminates the need for packing and cleaning validation and has100X higher binding capacity to proteins, viruses, virus-like particles and other large complexes when compared to resins.

    Production capsules will be available at a later date.


Need help streamlining your process?

Our experts will work with you to help find the optimal 3M purification and filtration solution for your application and to test our products within your process. We also provide trial data when we work with you to demonstrate product in-use.


Featured Applications

From cell culture fluid clarification and soluble impurity reduction to mycoplasma retention and final sterilizing filtration, our technologies deliver economical, robust solutions for a wide variety of applications within biopharmaceutical production.

  • Clarification tools designed for particle size control in the clarified cell culture fluid. 3M offers efficient depth filters that enable high throughput. This can eliminate the need for centrifugation and enables the implementation of a fully single-use clarification process train, completely scalable from lab to pilot to manufacturing scale.

  • Reduce insoluble impurities to help prevent plugging or fouling of capture and polishing chromatography columns.

  • Reduce microorganisms and control fine particles downstream.

  • Reduce DNA to target specification to help meet U.S. FDA requirements for protein therapeutic formulations.

  • 3M Polisher ST is compact, small footprint solution.

    Polishing

    The single-use, anion exchange chromatography (AEX) solution found in 3M Polisher ST is designed for the downstream processing of monoclonal antibodies (mAbs) and other recombinant proteins in flow-through mode. It is designed to reduce host cell protein impurities, viruses and other negatively charged contaminants through the use of two complementary AEX-functional media: 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. Under typical conditions, the salt-tolerant guanidinium functional membrane provides high HCPand virus reduction performance in a wider range of pH and conductivities compared to conventional Q-functional AEX resins.

    Photographs used are representative of the production scale capsule, which will be available on a future date


Need help finding the right bioprocessing product?

Our experts will work with you to help find the optimal 3M purification and filtration solution for your application and to test our products within your process. We also provide trial data when we work with you to demonstrate the product in-use.