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Recombinant Protein Manufacturing

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Biopharmaceutical Manufacturing

  • When you work in the biotech industry, your aim is to reduce the time to market and improve the efficiency of the of biologics manufacturing process. 3M wants to help you do that.

    3M products combine our expertise in material science, filtration and polishing of proteins to provide solutions in upstream and downstream processing of biologics. 3M™ Zeta Plus™ Depth Filters, 3M™ Emphaze™ AEX Hybrid Purifier, 3M™ LifeASSURE™ Filters and 3M™ Polisher ST are single-use products that enable platformability and robust purification across diverse biopharmaceutical modalities. They are designed for all process stages from lab scale to manufacturing.

Monoclonal Antibodies Manufacturing

Monoclonal antibody (mAb) therapeutics manufacturing requires robust, scalable solutions throughout the process train from clarification to polishing.

3M Zeta Plus Depth Filters and 3M Emphaze AEX Hybrid Purifier are uniquely designed specifically for the biopharmaceutical industry, to optimise cell harvest and meet clarification needs. 3M Polisher ST is a new product engineered to be a single-use cost-efficient option, to increase yield and purity in therapeutic recombinant protein processes across most operating conditions.

  • 3M Emphaze AEX Product Family
    3M Emphaze AEX Hybrid Purifier

    3M Emphaze AEX Hybrid Purifier is a single-use technology for polishing stage clarification of mammalian cell culture fluid and is designed to reduce both soluble (DNA and HCP) 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 Product Family
    3M Polisher ST

    3M Polisher ST is our latest solution: a cost-efficient, single-use option to maximise purity and yield in the polishing of recombinant proteins across a wide range of operating conditions. 3M Polisher ST can be used to replace the downstream AEX polishing column in both fed batch and continuous manufacturing. It is a compact, small footprint solution with high loading capacity. 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. To facilitate this, it can be deployed in a batch process or as part of a connected continuous downstream process for the flexible facility of the future.


Bioprocessing reimagined

3M aims to support you in the development of more efficient bioprocesses. Chromatographic clarification of cell culture fluid using the 3M Emphaze AEX Hybrid Purifier enables the early removal of soluble impurities such as HCP, DNA and endotoxins, which allows the downstream unit operations to perform better. 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 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.

  • Click the red spots for more information
    Click the red spots for more information

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. 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.

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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 pharmaceutical 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. 3M Zeta Plus Depth Filters and 3M Emphaze AEX Hybrid Purifier help biopharmaceutical drug manufacturers design and deploy robust clarification processes. 3M solutions are designed for recombinant therapeutic proteins expressed in mammalian cells as well as 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 exchange (AEX) chromatography media, fine fibre nonwovens and fine particle reduction membranes to create novel purification solutions. The result is a synthetic, single-use clarifying product that provides high purity.

  • With five standard types of activated carbon filters for a broad range of uses, 3M offers you a high degree of application flexibility. Our filter portfolio is designed for purification of a range of chemical and biological pharmaceutical fluids.

  • 3M Polisher ST

    Polishing

    • The goal of the polishing step is 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 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 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 has 100X higher binding capacity to proteins, viruses, virus-like particles and other large complexes when compared to resins.
    • Lab scale capsules are available now. Production capsules will be available at a later date.
    • Discover 3M™ Polisher ST

Need help streamlining your process?

Our experts will work with you to help find the optimal 3M purification 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 clarified cell culture fluid. 3M offers efficient depth filters that enable high throughput. This can eliminate the need for centrifugation and enables 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.