- 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
3M Purification and Contaminant Removal Solutions
Drive efficiency in your biopharmaceutical manufacturing process.
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.
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
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Increased yields: >95% mAb recovery -
Higher purity: Robust removal of process and product related contaminants in a wide range of operating conditions -
Process intensification: Enables elimination of post viral inactivation (VI) depth and membrane filters
Designed for the flexible facility of the future
See what industry experts say about 3M™ Polisher ST
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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.
3M™ Polisher ST: A game-changer in polishing
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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
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AEX-functionalised non-woven fiberFour 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.
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AEX-functionalised membraneThree 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.
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.
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mAb recoveryWithout significant adjustments to pH and conductivity, 3M™ Polisher ST has robust performance with respect to HCP and DNA clearance and better mAb recovery.
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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.
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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.
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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.
3M™ Polisher ST FAQ
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Can a single-use 3M™ Polisher ST replace an AEX column?
Yes. Modern chromatographic membranes such as 3M™ Polisher ST have been shown to be robust and scalable from the bench up to production scales. This allows for a single-use chromatographic device to replace a large multi-use column, saving space and buffers.
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Can 3M™ Polisher ST be used to remove problematic host cell proteins (HCPs)?
Yes. Newer anion exchange functionalities such as guanidinium and, to a lesser extent, primary amines have been shown to be able to remove problematic HCPs under a wider range of conditions compared to traditional Q chemistries.
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What are the benefits of 3M™ Polisher ST in the downstream purification space?
Benefits of 3M™ Polisher ST include a smaller footprint, higher loading capacities, less buffer usage and no need to pack/repack/validate.
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Can 3M™ Polisher ST be used in viral clearance?
Yes, 3M™ Polisher ST is also an effective virus removal step as part of an orthogonal viral clearance technology platform. Under process conditions of pH 5.5 to 7.5 and 5 to 20 mS/cm, 4 to 7 LRV can be achieved. Viral clearance performance is independent of the format, for example, the traditional AEX column vs. 3M™ Polisher ST. Performance is directly related to the functional ligand, feed and process conditions used.
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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).
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Sterile filtration -
High throughput enabled by advanced pleat technology -
High contaminant capacity -
Fast flow rate
3M™ LifeASSURE™ products are suited for a variety of applications
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- Cell culture media and additives
- Serum
- Vaccines
- Pharmaceutical bulk chemical solutions
- Intermediate process filtration
- Buffers
Membrane filtration FAQ
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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.
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What is the difference between a sterilising grade membrane and a bioburden reduction 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.
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What types of materials or polymers are membranes made from?
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).
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Where in a process is a membrane required/typical?
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.
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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?
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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
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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.
