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 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 optimize cell harvest and clarification needs. 3M Polisher ST is 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. The newest 3M solution, 3M™ Harvest RC, utilizes fibrous anion exchange (AEX) chromatography to efficiently separate cells, cell debris and DNA from the harvest fluid containing the target product.

  • 3M Harvest RC
    • High product recovery (> 95%), single-stage, single-use, encapsulated harvest and clarification solution for recombinant proteins expressed in high-density Chinese hamster ovary (CHO) cell cultures
    •  Innovative fully synthetic fibrous anion exchange chromatography media, combined with 0.2 µm polyethersulfone (PES) membrane, enable high degree of soluble and insoluble contaminant reduction while protecting the final sterilizing grade membrane down to 0.1 µm in pore size
    • Chromatographic single-stage clarification and versatile product line enables simple deployment and consistent scale-up of the system from discovery to manufacturing across different cell cultures
  • 3M Emphaze AEX Hybrid Purifier
    • Encapsulated single-use chromatographic clarification technology for polishing stage clarification of recombinant proteins expressed in mammalian cell cultures
    • Combination of synthetic fibrous AEX media and 0.2 µm polyamide membrane enables high efficiency of insoluble (< 5 NTU) and key soluble > 4 LRV of DNA contaminant reduction
    • The 3M Zeta Plus Depth Filter together with 3M Emphaze AEX Hybrid Purifier enable centrifuge replacement with a scalable single-use harvest and clarification solution
    • Scalable product line enables simple and rapid scale up from small scale lab to commercial manufacturing
  • 3M Polisher ST
    • High-performance, scalable, single-use replacement of polishing anion exchange (AEX) column
    • Combination of quaternary ammonium (Q) fibrous media and a guanidinium (Gu) ligand functionalized membrane enable potent reduction of DNA and HCP across a wide range of pH, conductivity and various buffer types
    • Salt- and pH-tolerant Gu ligand enable robust viral clearance across a wide range of pH and salt concentrations
    • Scalable single-use product line enables compact footprint, consistent integrity test method and rapid scale up from lab to manufacturing

Bioprocessing reimagined

You can achieve higher yield through chromatographic clarification of cell culture fluid with reduction turbidity, HCP and DNA. Our newest solution, 3M Harvest RC, encapsulates innovative synthetic fibrous anion exchange (AEX) chromatography media and a 0.2 µm polyether sulfone (PES) membrane. This enables a single-stage clarification process of low- to high-density cell culture (> 40 million cells per mL) with high recovery and high fidelity of soluble and insoluble contaminant separation.

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. 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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Next-generation process

3M™ Harvest RC
  • Removes soluble and insoluble contaminants
  • Turbidity reduction from >2000 to <15 NTU
  • High mAb recovery, >95%
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Quality and reliability

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

View all products
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.

  • 3M™ Harvest RC is the next generation in harvest and clarification technology for high cell density cultures. This solution is designed as an efficient option to increase monoclonal antibody (mAb) yields while simplifying the upstream process by replacing the centrifuge and/or depth filtration unit operations.

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

  • 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.

Harvest and polishing solutions

  • Individual in protective clothing working with the newly introduced 3M™ Harvest RC
    Harvest

    Introducing 3M™ Harvest RC: a new single-stage, single-use chromatographic clarification solution. It is the next generation in harvest and clarification technology and 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.

    • 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
  • Individual working with the 3M Polisher ST product
    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.

     


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.


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 product in-use.