Female scientist using a pipette to move liquid

3M Purification and Contaminant Removal Solutions

Drive efficiency in your biopharmaceutical manufacturing process.

Optimise biopharmaceutical manufacturing with novel technologies

Process-related impurity and bioburden control is critical in the biomanufacturing process. With continuously increasing demand to deliver high-quality biopharmaceuticals at an accelerated speed to market, manufacturers needs solutions that work through the entire process. 3M has proven solutions and expertise that help you address HCP reduction, viral clearance and bioburden control for a variety of applications leveraging membrane and chromatographic technologies.

A male scientist in white lab coat standing next to a 3M™ Encapsulated System Holder, Small 16EZA, loaded with 3M™ Polisher St. Next to them is a male scientist in blue lab coat standing besides a competitor's column.
Purification. Simplified.

3M™ Polisher ST is the next generation in single-use anion exchange technology, designed as a cost-efficient option to increase yields in therapeutic recombinant protein processing.

Looking to improve your anion exchange unit operation? 3M™ Polisher ST offers the flexibility to operate in a wide range of conditions and can replace anion exchange polishing columns or membrane adsorbers in fed batch and/or continuous manufacturing processes. 3M™ Polisher ST is a compact solution with greater capacity for delivering higher purity and yield in the downstream polishing unit operation.

Benefits of 3M™ Polisher ST

  • Arrows pointing upwards icon
    Increased yields: >95% mAb recovery
  • Arrows pointing upwards icon
    Higher purity: Robust removal of process and product related contaminants in a wide range of operating conditions
  • Bar graph icon with arrow pointing up
    Process intensification: Enables elimination of post viral inactivation (VI) depth and membrane filters

Designed for the flexible facility of the future

  • Infographic showing a standard Q column in size relative to a smaller 3M(TM) Polisher ST

    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.

See what industry experts say about 3M™ Polisher ST

  • Cover of 3M™ Polisher ST Beta Testing Series

    Many industry experts participated in the 3M™ Polisher ST beta test program and found that one of the key benefits is its performance across all tested process conditions. Its disposability, speed and ease of use were also key advantages. Find out more about major benefits hailed by expert panelists.

    View the Virtual Think Tank article

3M™ Polisher ST: A game-changer in polishing

  • Cover of 3M™ Polisher ST— The Next Frontier in Downstream Processing

    3M™ Polisher ST is being tested in different polishing mAb process train layouts and is on target to replace the AEX flow-through column in a variety of conditions.

    This highlights an excellent opportunity to invest in new intensification technologies and demonstrate a clear increase in return on assets/investment (RoA/RoI) and plant productivity.

    Read The Infographic of Next Frontier in Downstream Processing

A synthetic, fully encapsulated single-use AEX device containing two complementary AEX-functionalised media

  • A scanning electron microscopy showing the nonwoven fiber
    AEX-functionalised non-woven fiber

    Four layers of Q functionalised non-woven fiber provide reduction of turbidity (when present), DNA and endotoxin. These layers can also provide a portion of the product’s AEX capacity for HCP and virus reduction.

  • A scanning electron microscopy showing the membrane
    AEX-functionalised membrane

    Three layers of guanidinium-functionalised membrane provide HCP and viral reduction in a salt tolerant manner compared with conventional Q-functional technologies.

Introducing the novel guanidinium ligand

The novel guanidinium functionality of the downstream AEX polishing membrane mimics arginine, one of three positively charged standard amino acids that make up proteins. It can interact to form robust salt bridges that involve two hydrogen bonding interactions in addition to an electrostatic interaction.

This novel ligand enables robust impurity removal and viral clearance across a variety of conditions and its high density enables 50-100x higher mAb loading capacity than traditional chromatography resin beads.

  • Molecular structure of guanidinium ligand
  • Interaction of protein carboxylate group with the guanidinium ligand

Performance: Streamlined polishing and viral clearance

Achieve robust HCP and viral clearance while increasing process yields

Infographic showing that a 3-step polishing step is compressed into a single stage process by using 3M™ Polisher ST

Intensify your polishing step.

3M™ Polisher ST compresses the downstream polishing process by eliminating the need for depth and membrane filters used for column protection.

  • Bar chart showing the mAb recovery in % at various pH levels by using 3M™ Polisher ST
    mAb recovery

    Without significant adjustments to pH and conductivity, 3M™ Polisher ST has robust performance with respect to HCP and DNA clearance and better mAb recovery.

  • Bar chart showing the HCP reduction in % at various pH level by using 3M™ Polisher ST
    HCP reduction
    • Approximately 500 ppm HCP in a VIN mAb pool
    • More than 60% removal in Phosphate buffer
    • More than 22% removal in Citrate buffer

Robust viral clearance

3M™ Polisher ST removes HCP and DNA and is also an effective virus removal step as part of an orthogonal viral clearance technology platform. AEX performance of the guanidinium-functional membrane of 3M™ Polisher ST provides HCP and virus reduction in a salt tolerant (ST) manner.

  • Cover of 3M™ Polisher ST brochure

    Robust viral clearance is achieved over a range of buffer and pH conditions, which provide a wide design space for operation. Performance is maintained at high conductivity (20 mS/cm) even in citrate buffer, which reduces the need for feed dilution or buffer exchange requirement resulting in a simplified process with reduced cost factors.

    Read the test data here

  • Cover of Streamlined Polishing and Viral Clearance Using a New Hybrid, Biomimetic, Single-Use Anion Exchanger

    See results for streamlined polishing and viral clearance

    Learn about the potential for simplification of downstream polishing. Our results show the capability to replace complex, buffer hungry, condition-limiting AEX resin columns with simple, small-footprint, single-use chromatography devices. These devices offer a high degree of flexibility in buffer types and fluid conditions, providing HCP and viral clearance even in the presence of turbidity. Investigators working with prototypes of the single-use AEX device have also been able to simplify their mAb purification processes significantly in turbid post-viral inactivation fluids by eliminating a unit process and avoiding the process fluid dilution required for an alternative commercial, non-salt tolerance AEX single-use device.

    Read the paper

Ask an expert

Fill out this form for any technical, business or process-related question, and an appropriate 3M Biopharmaceutical representative will contact you to answer your question or direct your request.

Request a sample

Fill out this form and a 3M Biopharmaceutical representative will contact you to help you select and receive a sample or trial based on your needs.

3M™ LifeASSURE™ Filters

Membrane Filtration

Advanced pleat technology enables high capacity and sterilising grade filters for biopharmaceutical manufacturing processes.

Biopharmaceutical membrane filters overview

3M™ LifeASSURE™ Filters are ideal for biopharmaceutical manufacturing applications where low protein binding is critical. Our 3M series of membrane filters are optimised for both high-throughput and fast-flow applications. Our membrane filters offer 0.1pm and 0.2pm absolute rated filtration and increased effective filtration area (EFA) due to our Advance Pleat Technology (APT).

  • Hands showing care icon
    Sterile filtration
  • Arrows pointing upwards icon
    High throughput enabled by advanced pleat technology
  • Expansion icon
    High contaminant capacity
  • Water flow icon
    Fast flow rate

3M™ LifeASSURE™ products are suited for a variety of applications

    • Cell culture media and additives​
    • Serum​
    • Vaccines​
    • Pharmaceutical bulk chemical solutions​
    • Intermediate process filtration​
    • Buffers

Membrane filtration FAQ

See all 3M™ LifeASSURE™ filters
  • What is a membrane filter?
    Membrane filters are a physical barrier with a defined pore size, or absolute rating, that allows particles smaller than that pore size to flow through into the permeate, while particles that are larger remain in the retentate, or feed side, of the membrane.
  • Sterile is defined as a validated condition or process that results in the complete exclusion and removal of all live microbes in a product [1]. Bioburden is the quantification for identifying the population number of viable micro-organisms in a product sample prior to sterile filtration [1]. Since classification of a sterilising grade filter by pore size has limited value, the determination is defined by the filter’s bacterial retention performance. Therefore, a sterilising grade membrane will reproducibly remove 100% of a test microbial contaminant while a bioburden reduction membrane will reduce the microbial level down to a pre-determined amount that is suitable for a process to handle.
  • Membranes can be constructed from a range of materials from polymers to metal to ceramics. For biopharmaceutical applications, the material choices include polyamide (nylon), polyethersulfone (PES), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), cellulose acetate, cellulose nitrate and polypropylene (PP).
  • For a mAb process, microfiltration membranes are used to pre-condition buffers and media before they are fed into various unit operations, as well as before and after chromatographic steps and at the end of the purification process before fill and finish. Ultrafiltration membrane filters are also used in the ultrafiltration/diafiltration (UF/DF) steps.
  • References

    ¹Parenteral Drug Association, PDA J. Pharma. Sci. Technol., Technical Report No. 26 – Sterilising Filtration of Liquids, 2008, 62, No. S-5

Need help choosing the right product for the job?​

Get help with finding the optimal 3M biopharmaceutical solution for your application. Our experts can work with you to find products that will work with your process.

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.

Find 3M biopharmaceutical solutions

  • Find solutions for cell culture purification while driving efficiency whether you are using depth filtration or fiber chromatographic clarification.

  • Find solutions for more efficient bioprocessing across our portfolio.

Explore applications

  • 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.​

  • 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.

  • 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.

  • 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.​
  • 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.