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.
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 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.
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.
Three layers of guanidinium-functionalized membrane provide HCP and viral reduction in a salt tolerant manner compared with conventional Q-functional technologies.
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.
3M™ Polisher ST compresses the downstream polishing process by eliminating the need for depth and membrane filters used for column protection.
Without significant adjustments to pH and conductivity, 3M™ Polisher ST has robust performance with respect to HCP and DNA clearance and better mAb recovery.
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.
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.
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.
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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).
¹Parenteral Drug Association, PDA J. Pharma. Sci. Technol., Technical Report No. 26 – Sterilising Filtration of Liquids, 2008, 62, No. S-5
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.
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.
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.
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.